Is there a generic for Hydrocortisone?

Yes. The FDA Orange Book lists 131 approved generic (ANDA) applications for Hydrocortisone, referencing the brand KHINDIVI. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Hydrocortisone?

KHINDIVI (NDA 218980, ETON) is the reference-listed drug, the approved product a generic applicant must show its version is the same as.

What patents protect Hydrocortisone?

The Orange Book lists 5 patents against Hydrocortisone products, with the earliest listed expiry in 2032. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

What dosage forms of Hydrocortisone are approved?

Hydrocortisone is approved in the following dosage forms: aerosol, cream, enema, gel, granule, injectable, lotion, ointment, powder, solution, tablet.

FDA Orange Book · active-ingredient family

Hydrocortisone

Hydrocortisone: 12 brands, 131 generics; first approved Mar 29, 1982; generic available.

Generic availableHas discontinued products

Generic status & protection

Generic available: 131 ANDA applications approved.

Earliest patent expiry Nov 19, 2032

Brands (NDA)

Generics (ANDA)

131

Listed patents

Next patent expiry

Nov 19, 2032

in 6 yr 2 mo

Brand (NDA) products

Originator applications

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KHINDIVIRLDRS
ETONNDA 2189802025
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1MG/ML SOLUTION ORAL Rx -
ALKINDI SPRINKLERLDRS
ETONNDA 21387620204 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.5MG GRANULE ORAL Rx -
1MG GRANULE ORAL Rx -
2MG GRANULE ORAL Rx -
5MG GRANULE ORAL Rx -
CORTENEMARLDRS
ANI PHARMSNDA 016199-
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
100MG/60ML ENEMA RECTAL Rx AB
CORTEFRLD
PHARMACIA AND UPJOHNNDA 008697-3 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10MG TABLET ORAL Rx AB
20MG TABLET ORAL Rx AB
5MG TABLET ORAL Rx AB
CORT-DOME
BAYER PHARMSNDA 009585-2 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% CREAM TOPICAL Discontinued -
0.5% CREAM TOPICAL Discontinued -
CORTEF
PHARMACIA AND UPJOHNNDA 009864-
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
50MG/ML INJECTABLE INJECTION Discontinued -
CORT-DOME
BAYER PHARMSNDA 009895-2 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% LOTION TOPICAL Discontinued -
0.5% LOTION TOPICAL Discontinued -
CORTRIL
PFIZER GLOBALNDA 009176-2 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% OINTMENT TOPICAL Discontinued -
2.5% OINTMENT TOPICAL Discontinued -
CORTRIL
PFIZERNDA 009127-2 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
20MG TABLET ORAL Discontinued -
10MG TABLET ORAL Discontinued -
HYDROCORTISONE
PANRAYNDA 009659-2 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10MG TABLET ORAL Discontinued -
20MG TABLET ORAL Discontinued -
HYDROCORTONE
MERCKNDA 008506-2 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10MG TABLET ORAL Discontinued -
20MG TABLET ORAL Discontinued -
CORTRIL
PFIPHARMECSNDA 009796-
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10MG TABLET VAGINAL Discontinued -

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1MG/ML	SOLUTION	ORAL	Rx	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.5MG	GRANULE	ORAL	Rx	-
1MG	GRANULE	ORAL	Rx	-
2MG	GRANULE	ORAL	Rx	-
5MG	GRANULE	ORAL	Rx	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
100MG/60ML	ENEMA	RECTAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG	TABLET	ORAL	Rx	AB
20MG	TABLET	ORAL	Rx	AB
5MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1%	CREAM	TOPICAL	Discontinued	-
0.5%	CREAM	TOPICAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
50MG/ML	INJECTABLE	INJECTION	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1%	LOTION	TOPICAL	Discontinued	-
0.5%	LOTION	TOPICAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1%	OINTMENT	TOPICAL	Discontinued	-
2.5%	OINTMENT	TOPICAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
20MG	TABLET	ORAL	Discontinued	-
10MG	TABLET	ORAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG	TABLET	ORAL	Discontinued	-
20MG	TABLET	ORAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG	TABLET	ORAL	Discontinued	-
20MG	TABLET	ORAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG	TABLET	VAGINAL	Discontinued	-

Generic (ANDA) products (131)

Abbreviated applications

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HYDROCORTISONE
RISINGANDA 2182982026
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2.5% LOTION TOPICAL Rx AT
HYDROCORTISONE
APPCOANDA 22032920263 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5MG TABLET ORAL Rx AB
10MG TABLET ORAL Rx AB
20MG TABLET ORAL Rx AB
HYDROCORTISONE
NOVITIUM PHARMAANDA 21788120253 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5MG TABLET ORAL Rx AB
10MG TABLET ORAL Rx AB
20MG TABLET ORAL Rx AB
HYDROCORTISONE
HIBROW HLTHCAREANDA 21716020243 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5MG TABLET ORAL Rx AB
10MG TABLET ORAL Rx AB
20MG TABLET ORAL Rx AB
HYDROCORTISONE
AUROBINDO PHARMA LTDANDA 21464920233 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5MG TABLET ORAL Rx AB
10MG TABLET ORAL Rx AB
20MG TABLET ORAL Rx AB
HYDROCORTISONE
ENCUBEANDA 2038042018
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2.5% LOTION TOPICAL Discontinued -
HYDROCORTISONE
ENCUBEANDA 2038102018
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2.5% CREAM TOPICAL Rx AT
HYDROCORTISONE
STRIDES PHARMAANDA 20702920173 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5MG TABLET ORAL Rx AB
10MG TABLET ORAL Rx AB
20MG TABLET ORAL Rx AB
ALA-CORT
CROWN LABSANDA 08070620162 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% CREAM TOPICAL Rx AT
2.5% CREAM TOPICAL Rx AT
HYDROCORTISONE
HIKMA INTL PHARMSANDA 08336520153 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
20MG TABLET ORAL Discontinued -
5MG TABLET ORAL Discontinued -
10MG TABLET ORAL Discontinued -
HYDROCORTISONE
RISINGANDA 0408792010
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2.5% CREAM TOPICAL Rx AT
HYDROCORTISONE
STRIDES PHARMA INTLANDA 04076120073 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5MG TABLET ORAL Discontinued -
10MG TABLET ORAL Discontinued -
20MG TABLET ORAL Discontinued -
HYDROCORTISONE
IMPAX LABS INCANDA 04064620073 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5MG TABLET ORAL Rx AB
10MG TABLET ORAL Rx AB
20MG TABLET ORAL Rx AB
HYDROCORTISONE
CHARTWELL MOLECULARANDA 0405032004
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2.5% CREAM TOPICAL Discontinued -
HYDROCORTISONE
CHARTWELL MOLECULARANDA 0404172003
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2.5% LOTION TOPICAL Discontinued -
HYDROCORTISONE
SUN PHARMA CANADAANDA 0403102000
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2.5% OINTMENT TOPICAL Discontinued -
HYDROCORTISONE
FOUGERA PHARMSANDA 0403512000
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2.5% LOTION TOPICAL Discontinued -
COLOCORT
CHARTWELLANDA 0751721999
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
100MG/60ML ENEMA RECTAL Rx AB
HYDROCORTISONE
SUN PHARMA CANADAANDA 0402471999
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2.5% LOTION TOPICAL Discontinued -
HYDROCORTISONE
TEVA PHARMSANDA 0741711994
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
100MG/60ML ENEMA RECTAL Discontinued -
HYDROCORTISONERS
FOUGERA PHARMS INCANDA 0812031993
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2.5% OINTMENT TOPICAL Rx AT
TEXACORTRS
MISSION PHARMAANDA 0812711992
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2.5% SOLUTION TOPICAL Rx -
HYDROCORTISONE
TOPIDERMANDA 0892731989
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% CREAM TOPICAL Discontinued -
HYDROCORTISONE
ALPHARMA US PHARMSANDA 0897541989
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2.5% CREAM TOPICAL Discontinued -
HYDROCORTISONE
NASKAANDA 0897051988
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% LOTION TOPICAL Discontinued -
NOGENIC HC
IVAX PHARMSANDA 0874271988
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% CREAM TOPICAL Discontinued -
HYDROCORTISONE
ACTAVIS MID ATLANTICANDA 0896821988
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2.5% CREAM TOPICAL Discontinued -
HYDROCORTISONE
NASKAANDA 0897061988
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% CREAM TOPICAL Discontinued -
HYDROCORTISONE
NASKAANDA 0897041988
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% OINTMENT TOPICAL Discontinued -
BETA-HC
BETA DERMACANDA 0894951988
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% LOTION TOPICAL Discontinued -
HYDROCORTISONE
PHARMADERMANDA 0888421987
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% OINTMENT TOPICAL Discontinued -
HYDROCORTISONERS
FOUGERA PHARMS INCANDA 0894141986
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2.5% CREAM TOPICAL Rx AT
HYDROCORTISONE
PHARMADERMANDA 0894131986
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2.5% CREAM TOPICAL Discontinued -
HYDROCORTISONE
PHARMADERMANDA 0888451986
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% CREAM TOPICAL Discontinued -
HYDROCORTISONE
TAROANDA 0890241986
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% LOTION TOPICAL Discontinued -
STIE-CORTRS
PADAGIS USANDA 0890741985
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2.5% LOTION TOPICAL Rx AT
STIE-CORT
PADAGIS USANDA 0890661985
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% LOTION TOPICAL Discontinued -
HYDROCORTISONE IN ABSORBASE
CMP PHARMA INCANDA 0881381985
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% OINTMENT TOPICAL Rx AT
HYDROCORTISONE
TAROANDA 0887991984
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2.5% CREAM TOPICAL Rx AT
ANUSOL HC
SALIX PHARMSANDA 0882501984
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2.5% CREAM TOPICAL Discontinued -
PENECORT
ALLERGAN HERBERTANDA 0882161984
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% CREAM TOPICAL Discontinued -
PENECORT
ALLERGAN HERBERTANDA 0882151984
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% GEL TOPICAL Discontinued -
PENECORT
ALLERGAN HERBERTANDA 0882171984
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2.5% OINTMENT TOPICAL Discontinued -
PENECORTRLD
ALLERGAN HERBERTANDA 0882141984
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% SOLUTION TOPICAL Discontinued -
HYDROCORTISONE
ROXANEANDA 0885391984
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10MG TABLET ORAL Discontinued -
GLYCORT
HERANANDA 0874891983
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% LOTION TOPICAL Discontinued -
HYDROCORTISONE
USL PHARMAANDA 0880271983
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% CREAM TOPICAL Discontinued -
HYDROCORTISONE
USL PHARMAANDA 0880291983
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2.5% CREAM TOPICAL Discontinued -
HYDROCORTISONE
USL PHARMAANDA 0880611983
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% OINTMENT TOPICAL Discontinued -
HYDROCORTISONE
USL PHARMAANDA 0880391983
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2.5% OINTMENT TOPICAL Discontinued -
HYDROCORTISONE
ACTAVIS MID ATLANTICANDA 0877951983
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% CREAM TOPICAL Rx AT
HYDROCORTISONE
PADDOCK LLCANDA 0880821983
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
100% POWDER FOR RX COMPOUNDING Discontinued -
BALNEOL-HC
SOLVAYANDA 0880411982
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% LOTION TOPICAL Discontinued -
HYDROCORTISONE
ACTAVIS MID ATLANTICANDA 0877961982
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% OINTMENT TOPICAL Discontinued -
HYDROCORTISONE
PUREPAC PHARMANDA 08424719822 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
20MG TABLET ORAL Discontinued -
10MG TABLET ORAL Discontinued -
NUTRACORT
DOW PHARMANDA 0876441982
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2.5% LOTION TOPICAL Discontinued -
HYDROCORTISONE
PHARMAFAIRANDA 0878381982
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% CREAM TOPICAL Discontinued -
HYDROCORTISONE
ALPHARMA US PHARMSANDA 0873171982
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.5% LOTION TOPICAL Discontinued -
HYDROCORTISONE
ALPHARMA US PHARMSANDA 0873151982
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% LOTION TOPICAL Discontinued -
FLEXICORT
WESTWOOD SQUIBBANDA 08713619823 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2.5% CREAM TOPICAL Discontinued -
1% CREAM TOPICAL Discontinued -
0.5% CREAM TOPICAL Discontinued -
H-CORT
TORCHANDA 0878341982
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
100% POWDER FOR RX COMPOUNDING Discontinued -
AEROSEB-HC
ALLERGAN HERBERTANDA 085805-
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.5% AEROSOL TOPICAL Discontinued -
DERMACORT
MONARCH PHARMSANDA 083011-2 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% CREAM TOPICAL Discontinued -
1% CREAM TOPICAL Discontinued -
ELDECORT
VALEANT PHARM INTLANDA 080459-
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% CREAM TOPICAL Discontinued -
ELDECORT
VALEANT PHARM INTLANDA 084055-
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2.5% CREAM TOPICAL Discontinued -
H-CORT
PHARM ASSOCANDA 086823-
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.5% CREAM TOPICAL Discontinued -
HC #1
BAYER PHARMSANDA 080438-2 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.5% CREAM TOPICAL Discontinued -
1% CREAM TOPICAL Discontinued -
HC (HYDROCORTISONE)
C AND M PHARMAANDA 080482-2 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.5% CREAM TOPICAL Discontinued -
1% CREAM TOPICAL Discontinued -
HI-COR
C AND M PHARMAANDA 080483-
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2.5% CREAM TOPICAL Discontinued -
HYDROCORTISONE
ALTANAANDA 080848-2 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.5% CREAM TOPICAL Discontinued -
1% CREAM TOPICAL Discontinued -
HYDROCORTISONE
AMBIXANDA 086080-
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% CREAM TOPICAL Discontinued -
HYDROCORTISONE
AMBIXANDA 086271-
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2.5% CREAM TOPICAL Discontinued -
HYDROCORTISONE
EVERYLIFEANDA 080452-2 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.5% CREAM TOPICAL Discontinued -
1% CREAM TOPICAL Discontinued -
HYDROCORTISONERLDRS
FOUGERA PHARMS INCANDA 080693-
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% CREAM TOPICAL Rx AT
HYDROCORTISONE
G AND W LABSANDA 084059-
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% CREAM TOPICAL Discontinued -
HYDROCORTISONE
INGRAM PHARMANDA 080456-2 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.5% CREAM TOPICAL Discontinued -
1% CREAM TOPICAL Discontinued -
HYDROCORTISONE
IVAX PHARMSANDA 085733-
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% CREAM TOPICAL Discontinued -
HYDROCORTISONE
PADAGIS USANDA 085025-
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2.5% CREAM TOPICAL Rx AT
HYDROCORTISONE
PERRIGO NEW YORKANDA 084970-
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.5% CREAM TOPICAL Discontinued -
HYDROCORTISONE
PERRIGO NEW YORKANDA 085026-
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% CREAM TOPICAL Discontinued -
HYDROCORTISONE
STIEFELANDA 086170-
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% CREAM TOPICAL Discontinued -
HYDROCORTISONE
SYOSSETANDA 085527-
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.5% CREAM TOPICAL Discontinued -
HYDROCORTISONE
TAROANDA 086154-
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.5% CREAM TOPICAL Discontinued -
HYDROCORTISONE
TAROANDA 086155-
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% CREAM TOPICAL Discontinued -
HYDROCORTISONE
TEVAANDA 080400-3 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.5% CREAM TOPICAL Discontinued -
1% CREAM TOPICAL Discontinued -
2.5% CREAM TOPICAL Discontinued -
HYDROCORTISONE
TEVAANDA 085191-
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% CREAM TOPICAL Discontinued -
HYDROCORTISONE
WHITEWORTH TOWN PLSNANDA 080496-
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% CREAM TOPICAL Discontinued -
HYTONERLD
VALEANT INTLANDA 080472-2 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% CREAM TOPICAL Discontinued -
2.5% CREAM TOPICAL Discontinued -
NUTRACORT
BAUSCHANDA 080442-2 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.5% CREAM TOPICAL Discontinued -
1% CREAM TOPICAL Discontinued -
SYNACORT
BAUSCHANDA 087459-
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.5% CREAM TOPICAL Discontinued -
SYNACORTRLD
BAUSCHANDA 087458-
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% CREAM TOPICAL Discontinued -
SYNACORTRLD
BAUSCHANDA 087457-
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2.5% CREAM TOPICAL Discontinued -
NUTRACORTRLD
HEALTHPOINTANDA 084698-
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% GEL TOPICAL Discontinued -
ACTICORT
BAKER NORTONANDA 086535-
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% LOTION TOPICAL Discontinued -
ALA-CORT
CROWN LABSANDA 083201-
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% LOTION TOPICAL Discontinued -
ALA-SCALPRLD
LEGACYANDA 083231-
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2% LOTION TOPICAL Rx -
CETACORT
BAUSCHANDA 080426-2 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% LOTION TOPICAL Discontinued -
0.5% LOTION TOPICAL Discontinued -
DERMACORT
SOLVAYANDA 084573-
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.5% LOTION TOPICAL Discontinued -
DERMACORT
SOLVAYANDA 086462-
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% LOTION TOPICAL Discontinued -
EPICORT
BLULINEANDA 083219-
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.5% LOTION TOPICAL Discontinued -
H-CORT
PHARM ASSOCANDA 086824-
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.5% LOTION TOPICAL Discontinued -
HYDROCORTISONE
MERICONANDA 085282-2 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.5% LOTION TOPICAL Discontinued -
1% LOTION TOPICAL Discontinued -
HYDROCORTISONE
PERRIGO NEW YORKANDA 085662-
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.5% LOTION TOPICAL Discontinued -
HYDROCORTISONE
PERRIGO NEW YORKANDA 085663-
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% LOTION TOPICAL Discontinued -
HYTONERLD
VALEANT INTLANDA 080473-2 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% LOTION TOPICAL Discontinued -
2.5% LOTION TOPICAL Discontinued -
NUTRACORT
DOW PHARMANDA 080443-2 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.5% LOTION TOPICAL Discontinued -
1% LOTION TOPICAL Discontinued -
HC (HYDROCORTISONE)
C AND M PHARMAANDA 080481-2 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.5% OINTMENT TOPICAL Discontinued -
1% OINTMENT TOPICAL Discontinued -
HYDROCORTISONE
ALTANAANDA 080489-2 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.5% OINTMENT TOPICAL Discontinued -
1% OINTMENT TOPICAL Discontinued -
HYDROCORTISONE
AMBIXANDA 086079-
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% OINTMENT TOPICAL Discontinued -
HYDROCORTISONE
AMBIXANDA 086272-
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2.5% OINTMENT TOPICAL Discontinued -
HYDROCORTISONERLDRS
FOUGERA PHARMSANDA 080692-
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% OINTMENT TOPICAL Rx AT
HYDROCORTISONE
PADAGIS USANDA 085027-
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2.5% OINTMENT TOPICAL Rx AT
HYDROCORTISONE
PERRIGO NEW YORKANDA 084969-
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.5% OINTMENT TOPICAL Discontinued -
HYDROCORTISONE
PERRIGO NEW YORKANDA 085028-
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% OINTMENT TOPICAL Discontinued -
HYDROCORTISONE
SUN PHARMA CANADAANDA 086257-
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% OINTMENT TOPICAL Discontinued -
HYDROCORTISONE
TAROANDA 086256-
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.5% OINTMENT TOPICAL Discontinued -
HYTONERLD
DERMIK LABSANDA 080474-2 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% OINTMENT TOPICAL Discontinued -
2.5% OINTMENT TOPICAL Discontinued -
HYDRO-RX
X GEN PHARMSANDA 085982-
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
100% POWDER FOR RX COMPOUNDING Discontinued -
TEXACORT
MISSION PHARMAANDA 080425-
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% SOLUTION TOPICAL Discontinued -
HYDROCORTISONE
BARRANDA 083999-
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
20MG TABLET ORAL Discontinued -
HYDROCORTISONE
CHARTWELL MOLECULARANDA 085070-
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
20MG TABLET ORAL Discontinued -
HYDROCORTISONE
ELKINS SINNANDA 080624-
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
20MG TABLET ORAL Discontinued -
HYDROCORTISONE
FERRANTEANDA 080568-2 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10MG TABLET ORAL Discontinued -
20MG TABLET ORAL Discontinued -
HYDROCORTISONE
IMPAX LABSANDA 080781-
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
20MG TABLET ORAL Discontinued -
HYDROCORTISONE
INWOOD LABSANDA 080732-
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
20MG TABLET ORAL Discontinued -
HYDROCORTISONE
NEXGEN PHARMA INCANDA 083140-
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
20MG TABLET ORAL Discontinued -
HYDROCORTISONE
PARKE DAVISANDA 084243-
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
20MG TABLET ORAL Discontinued -
HYDROCORTISONE
PUREPAC PHARMANDA 080395-
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
20MG TABLET ORAL Discontinued -
HYDROCORTISONE
SANDOZANDA 080642-
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
20MG TABLET ORAL Discontinued -
HYDROCORTISONE
WATSON LABSANDA 080355-
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
20MG TABLET ORAL Discontinued -
HYDROCORTISONE
WHITEWORTH TOWN PLSNANDA 080344-2 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10MG TABLET ORAL Discontinued -
20MG TABLET ORAL Discontinued -

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2.5%	LOTION	TOPICAL	Rx	AT

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5MG	TABLET	ORAL	Rx	AB
10MG	TABLET	ORAL	Rx	AB
20MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5MG	TABLET	ORAL	Rx	AB
10MG	TABLET	ORAL	Rx	AB
20MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5MG	TABLET	ORAL	Rx	AB
10MG	TABLET	ORAL	Rx	AB
20MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5MG	TABLET	ORAL	Rx	AB
10MG	TABLET	ORAL	Rx	AB
20MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2.5%	LOTION	TOPICAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2.5%	CREAM	TOPICAL	Rx	AT

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5MG	TABLET	ORAL	Rx	AB
10MG	TABLET	ORAL	Rx	AB
20MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1%	CREAM	TOPICAL	Rx	AT
2.5%	CREAM	TOPICAL	Rx	AT

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
20MG	TABLET	ORAL	Discontinued	-
5MG	TABLET	ORAL	Discontinued	-
10MG	TABLET	ORAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2.5%	CREAM	TOPICAL	Rx	AT

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5MG	TABLET	ORAL	Discontinued	-
10MG	TABLET	ORAL	Discontinued	-
20MG	TABLET	ORAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5MG	TABLET	ORAL	Rx	AB
10MG	TABLET	ORAL	Rx	AB
20MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2.5%	CREAM	TOPICAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2.5%	LOTION	TOPICAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2.5%	OINTMENT	TOPICAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2.5%	LOTION	TOPICAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
100MG/60ML	ENEMA	RECTAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2.5%	LOTION	TOPICAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
100MG/60ML	ENEMA	RECTAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2.5%	OINTMENT	TOPICAL	Rx	AT

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2.5%	SOLUTION	TOPICAL	Rx	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1%	CREAM	TOPICAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2.5%	CREAM	TOPICAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1%	LOTION	TOPICAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1%	CREAM	TOPICAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2.5%	CREAM	TOPICAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1%	CREAM	TOPICAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1%	OINTMENT	TOPICAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1%	LOTION	TOPICAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1%	OINTMENT	TOPICAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2.5%	CREAM	TOPICAL	Rx	AT

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2.5%	CREAM	TOPICAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1%	CREAM	TOPICAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1%	LOTION	TOPICAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2.5%	LOTION	TOPICAL	Rx	AT

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1%	LOTION	TOPICAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1%	OINTMENT	TOPICAL	Rx	AT

Patent & exclusivity timeline

Protection horizon

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Patent expiryExclusivity endToday

Listed patents

Orange Book patent file

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Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
9717740	Nov 19, 2032	in 6 yr 2 mo	U-3075
9675559	Jan 10, 2033	in 6 yr 4 mo	U-3075
9649280	May 12, 2034	in 7 yr 8 mo	ProductU-3075
12133914	Feb 23, 2043	in 16 yr 7 mo	U-4215
11904046	Feb 23, 2043	in 16 yr 7 mo	ProductU-4216

Approval history

FDA approval span

Ask AI

First approval

Mar 29, 1982

45 yr 3 mo ago

Most recent approval

Jul 16, 2026

3 mo ago

Approvals span 1982–2026 across 143 FDA applications.

Brand (NDA) 128%

Generic (ANDA) 13192%

Hydrocortisone: frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Ask AI about Hydrocortisone

Key facts

Active ingredient: Hydrocortisone
Brand (NDA): 12
Generic (ANDA): 131
Reference-listed drug: KHINDIVI
Dosage forms: AEROSOL, CREAM, ENEMA, GEL, GRANULE, INJECTABLE, LOTION, OINTMENT, POWDER, SOLUTION, TABLET
Routes: FOR RX COMPOUNDING, INJECTION, ORAL, RECTAL, TOPICAL, VAGINAL
TE codes: AB, AT
Earliest patent expiry: Nov 19, 2032