Assyro AI

FDA Orange Book · active-ingredient family

Hydrocortisone

Hydrocortisone is approved as 12 brand and 130 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:KHINDIVI · NDA 218980

12

Brand (NDA)

130

Generics (ANDA)

5

Listed patents

0

Exclusivity periods

Brand (NDA) products · aerosol, cream, enema, gel, granule, injectable, lotion, ointment, powder, solution, tablet

ProductApplicantApplicationTEApproved
KHINDIVIRLDETONNDA 218980—May 28, 2025
ALKINDI SPRINKLERLD×4ETONNDA 213876—Sep 29, 2020
CORTENEMARLDANI PHARMSNDA 016199ABApproved Prior to Jan 1, 1982
CORTEFRLD×3PHARMACIA AND UPJOHNNDA 008697ABApproved Prior to Jan 1, 1982
CORT-DOME×2BAYER PHARMSNDA 009585—Approved Prior to Jan 1, 1982
CORTEFPHARMACIA AND UPJOHNNDA 009864—Approved Prior to Jan 1, 1982
CORT-DOME×2BAYER PHARMSNDA 009895—Approved Prior to Jan 1, 1982
CORTRIL×2PFIZER GLOBALNDA 009176—Approved Prior to Jan 1, 1982
CORTRIL×2PFIZERNDA 009127—Approved Prior to Jan 1, 1982
HYDROCORTISONE×2PANRAYNDA 009659—Approved Prior to Jan 1, 1982
HYDROCORTONE×2MERCKNDA 008506—Approved Prior to Jan 1, 1982
CORTRILPFIPHARMECSNDA 009796—Approved Prior to Jan 1, 1982

Generic (ANDA) products (130)

ProductApplicantApplicationTEApproved
HYDROCORTISONE×3APPCOANDA 220329ABFeb 25, 2026
HYDROCORTISONE×3NOVITIUM PHARMAANDA 217881ABMay 02, 2025
HYDROCORTISONE×3HIBROW HLTHCAREANDA 217160ABNov 25, 2024
HYDROCORTISONE×3AUROBINDO PHARMA LTDANDA 214649ABJul 17, 2023
HYDROCORTISONEENCUBEANDA 203804—Jul 27, 2018
HYDROCORTISONEENCUBEANDA 203810—Jul 23, 2018
HYDROCORTISONE×3STRIDES PHARMAANDA 207029ABApr 27, 2017
ALA-CORT×2CROWN LABSANDA 080706ATJan 05, 2016
HYDROCORTISONE×3HIKMA INTL PHARMSANDA 083365—Feb 23, 2015
HYDROCORTISONERISINGANDA 040879ATAug 20, 2010
HYDROCORTISONE×3STRIDES PHARMA INTLANDA 040761—Jul 16, 2007
HYDROCORTISONE×3IMPAX LABS INCANDA 040646ABMar 30, 2007
HYDROCORTISONECHARTWELL MOLECULARANDA 040503—Mar 12, 2004
HYDROCORTISONECHARTWELL MOLECULARANDA 040417—Jul 30, 2003
HYDROCORTISONESUN PHARMA CANADAANDA 040310—Dec 29, 2000
HYDROCORTISONEFOUGERA PHARMSANDA 040351—Jul 25, 2000
COLOCORTCHARTWELLANDA 075172ABDec 03, 1999
HYDROCORTISONESUN PHARMA CANADAANDA 040247—Jul 23, 1999
HYDROCORTISONETEVA PHARMSANDA 074171—May 27, 1994
HYDROCORTISONEFOUGERA PHARMS INCANDA 081203ATMay 28, 1993
TEXACORTMISSION PHARMAANDA 081271—Apr 17, 1992
HYDROCORTISONETOPIDERMANDA 089273—Feb 17, 1989
HYDROCORTISONEALPHARMA US PHARMSANDA 089754—Feb 01, 1989
HYDROCORTISONENASKAANDA 089705—Apr 25, 1988
NOGENIC HCIVAX PHARMSANDA 087427—Apr 04, 1988
HYDROCORTISONEACTAVIS MID ATLANTICANDA 089682ATMar 10, 1988
HYDROCORTISONENASKAANDA 089706—Mar 10, 1988
HYDROCORTISONENASKAANDA 089704—Mar 10, 1988
BETA-HCBETA DERMACANDA 089495—Jan 25, 1988
HYDROCORTISONEPHARMADERMANDA 088842—Feb 09, 1987
HYDROCORTISONEFOUGERA PHARMS INCANDA 089414ATDec 16, 1986
HYDROCORTISONEPHARMADERMANDA 089413—Dec 16, 1986
HYDROCORTISONEPHARMADERMANDA 088845—Feb 27, 1986
HYDROCORTISONETAROANDA 089024—Feb 12, 1986
STIE-CORTPADAGIS USANDA 089074—Nov 26, 1985
STIE-CORTPADAGIS USANDA 089066—Nov 25, 1985
HYDROCORTISONE IN ABSORBASECMP PHARMA INCANDA 088138ATSep 06, 1985
HYDROCORTISONETAROANDA 088799ATNov 09, 1984
ANUSOL HCSALIX PHARMSANDA 088250ATJun 06, 1984
PENECORTALLERGAN HERBERTANDA 088216—Jun 06, 1984
PENECORTALLERGAN HERBERTANDA 088215—Jun 06, 1984
PENECORTALLERGAN HERBERTANDA 088217—Jun 06, 1984
PENECORTRLDALLERGAN HERBERTANDA 088214—Jun 06, 1984
HYDROCORTISONEROXANEANDA 088539—Mar 21, 1984
GLYCORTHERANANDA 087489—Oct 03, 1983
HYDROCORTISONEUSL PHARMAANDA 088027—Sep 27, 1983
HYDROCORTISONEUSL PHARMAANDA 088029—Sep 27, 1983
HYDROCORTISONEUSL PHARMAANDA 088061—Sep 27, 1983
HYDROCORTISONEUSL PHARMAANDA 088039—Sep 27, 1983
HYDROCORTISONEACTAVIS MID ATLANTICANDA 087795ATMay 03, 1983
HYDROCORTISONEPADDOCK LLCANDA 088082—Apr 08, 1983
BALNEOL-HCSOLVAYANDA 088041—Dec 03, 1982
HYDROCORTISONEACTAVIS MID ATLANTICANDA 087796—Oct 13, 1982
HYDROCORTISONE×2PUREPAC PHARMANDA 084247—Aug 31, 1982
NUTRACORTDOW PHARMANDA 087644—Aug 24, 1982
HYDROCORTISONEPHARMAFAIRANDA 087838—Jul 28, 1982
HYDROCORTISONEALPHARMA US PHARMSANDA 087317—Jun 07, 1982
HYDROCORTISONEALPHARMA US PHARMSANDA 087315—Jun 07, 1982
FLEXICORT×3WESTWOOD SQUIBBANDA 087136—Apr 08, 1982
H-CORTTORCHANDA 087834—Mar 29, 1982
AEROSEB-HCALLERGAN HERBERTANDA 085805—Approved Prior to Jan 1, 1982
DERMACORT×2MONARCH PHARMSANDA 083011—Approved Prior to Jan 1, 1982
ELDECORTVALEANT PHARM INTLANDA 080459—Approved Prior to Jan 1, 1982
ELDECORTVALEANT PHARM INTLANDA 084055—Approved Prior to Jan 1, 1982
H-CORTPHARM ASSOCANDA 086823—Approved Prior to Jan 1, 1982
HC #1×2BAYER PHARMSANDA 080438—Approved Prior to Jan 1, 1982
HC (HYDROCORTISONE)×2C AND M PHARMAANDA 080482—Approved Prior to Jan 1, 1982
HI-CORC AND M PHARMAANDA 080483—Approved Prior to Jan 1, 1982
HYDROCORTISONE×2ALTANAANDA 080848—Approved Prior to Jan 1, 1982
HYDROCORTISONEAMBIXANDA 086080—Approved Prior to Jan 1, 1982
HYDROCORTISONEAMBIXANDA 086271—Approved Prior to Jan 1, 1982
HYDROCORTISONE×2EVERYLIFEANDA 080452—Approved Prior to Jan 1, 1982
HYDROCORTISONERLDFOUGERA PHARMS INCANDA 080693ATApproved Prior to Jan 1, 1982
HYDROCORTISONEG AND W LABSANDA 084059—Approved Prior to Jan 1, 1982
HYDROCORTISONE×2INGRAM PHARMANDA 080456—Approved Prior to Jan 1, 1982
HYDROCORTISONEIVAX PHARMSANDA 085733—Approved Prior to Jan 1, 1982
HYDROCORTISONEPADAGIS USANDA 085025ATApproved Prior to Jan 1, 1982
HYDROCORTISONEPERRIGO NEW YORKANDA 084970—Approved Prior to Jan 1, 1982
HYDROCORTISONEPERRIGO NEW YORKANDA 085026—Approved Prior to Jan 1, 1982
HYDROCORTISONESTIEFELANDA 086170—Approved Prior to Jan 1, 1982
HYDROCORTISONESYOSSETANDA 085527—Approved Prior to Jan 1, 1982
HYDROCORTISONETAROANDA 086154—Approved Prior to Jan 1, 1982
HYDROCORTISONETAROANDA 086155—Approved Prior to Jan 1, 1982
HYDROCORTISONE×3TEVAANDA 080400—Approved Prior to Jan 1, 1982
HYDROCORTISONETEVAANDA 085191—Approved Prior to Jan 1, 1982
HYDROCORTISONEWHITEWORTH TOWN PLSNANDA 080496—Approved Prior to Jan 1, 1982
HYTONERLD×2VALEANT INTLANDA 080472—Approved Prior to Jan 1, 1982
NUTRACORT×2BAUSCHANDA 080442—Approved Prior to Jan 1, 1982
SYNACORTBAUSCHANDA 087459—Approved Prior to Jan 1, 1982
SYNACORTRLDBAUSCHANDA 087458—Approved Prior to Jan 1, 1982
SYNACORTRLDBAUSCHANDA 087457—Approved Prior to Jan 1, 1982
NUTRACORTRLDHEALTHPOINTANDA 084698—Approved Prior to Jan 1, 1982
ACTICORTBAKER NORTONANDA 086535—Approved Prior to Jan 1, 1982
ALA-CORTCROWN LABSANDA 083201—Approved Prior to Jan 1, 1982
ALA-SCALPRLDLEGACY PHARMAANDA 083231—Approved Prior to Jan 1, 1982
CETACORT×2BAUSCHANDA 080426—Approved Prior to Jan 1, 1982
DERMACORTSOLVAYANDA 084573—Approved Prior to Jan 1, 1982
DERMACORTSOLVAYANDA 086462—Approved Prior to Jan 1, 1982
EPICORTBLULINEANDA 083219—Approved Prior to Jan 1, 1982
H-CORTPHARM ASSOCANDA 086824—Approved Prior to Jan 1, 1982
HYDROCORTISONE×2MERICONANDA 085282—Approved Prior to Jan 1, 1982
HYDROCORTISONEPERRIGO NEW YORKANDA 085662—Approved Prior to Jan 1, 1982
HYDROCORTISONEPERRIGO NEW YORKANDA 085663—Approved Prior to Jan 1, 1982
HYTONERLD×2VALEANT INTLANDA 080473—Approved Prior to Jan 1, 1982
NUTRACORT×2DOW PHARMANDA 080443—Approved Prior to Jan 1, 1982
HC (HYDROCORTISONE)×2C AND M PHARMAANDA 080481—Approved Prior to Jan 1, 1982
HYDROCORTISONE×2ALTANAANDA 080489—Approved Prior to Jan 1, 1982
HYDROCORTISONEAMBIXANDA 086079—Approved Prior to Jan 1, 1982
HYDROCORTISONEAMBIXANDA 086272—Approved Prior to Jan 1, 1982
HYDROCORTISONERLDFOUGERA PHARMSANDA 080692ATApproved Prior to Jan 1, 1982
HYDROCORTISONEPADAGIS USANDA 085027ATApproved Prior to Jan 1, 1982
HYDROCORTISONEPERRIGO NEW YORKANDA 084969—Approved Prior to Jan 1, 1982
HYDROCORTISONEPERRIGO NEW YORKANDA 085028—Approved Prior to Jan 1, 1982
HYDROCORTISONESUN PHARMA CANADAANDA 086257—Approved Prior to Jan 1, 1982
HYDROCORTISONETAROANDA 086256—Approved Prior to Jan 1, 1982
HYTONERLD×2DERMIK LABSANDA 080474—Approved Prior to Jan 1, 1982
HYDRO-RXX GEN PHARMSANDA 085982—Approved Prior to Jan 1, 1982
TEXACORTMISSION PHARMAANDA 080425—Approved Prior to Jan 1, 1982
HYDROCORTISONEBARRANDA 083999—Approved Prior to Jan 1, 1982
HYDROCORTISONECHARTWELL MOLECULARANDA 085070—Approved Prior to Jan 1, 1982
HYDROCORTISONEELKINS SINNANDA 080624—Approved Prior to Jan 1, 1982
HYDROCORTISONE×2FERRANTEANDA 080568—Approved Prior to Jan 1, 1982
HYDROCORTISONEIMPAX LABSANDA 080781—Approved Prior to Jan 1, 1982
HYDROCORTISONEINWOOD LABSANDA 080732—Approved Prior to Jan 1, 1982
HYDROCORTISONENEXGEN PHARMA INCANDA 083140—Approved Prior to Jan 1, 1982
HYDROCORTISONEPARKE DAVISANDA 084243—Approved Prior to Jan 1, 1982
HYDROCORTISONEPUREPAC PHARMANDA 080395—Approved Prior to Jan 1, 1982
HYDROCORTISONESANDOZANDA 080642—Approved Prior to Jan 1, 1982
HYDROCORTISONEWATSON LABSANDA 080355—Approved Prior to Jan 1, 1982
HYDROCORTISONE×2WHITEWORTH TOWN PLSNANDA 080344—Approved Prior to Jan 1, 1982

Listed patents (5)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
9717740Nov 19, 2032in 6 yr 6 mo
U-3075
9675559Jan 10, 2033in 6 yr 8 mo
U-3075
9649280May 12, 2034in 8 yr
ProductU-3075
12133914Feb 23, 2043in 16 yr 11 mo
U-4215
11904046Feb 23, 2043in 16 yr 11 mo
ProductU-4216

Hydrocortisone — frequently asked questions

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

Agent CTA Background

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.

Book a Demo