Is there a generic for Hydrocortisone butyrate?

Yes. The FDA Orange Book lists 7 approved generic (ANDA) applications for Hydrocortisone butyrate, referencing the brand LOCOID. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Hydrocortisone butyrate?

LOCOID (NDA 022076, BAUSCH) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Hydrocortisone butyrate are approved?

Hydrocortisone butyrate is approved in the following dosage forms: cream, lotion, ointment, solution.

FDA Orange Book · active-ingredient family

Hydrocortisone butyrate

Hydrocortisone butyrate: 8 brands, 7 generics; first approved Mar 31, 1982; generic available.

Generic availableHas discontinued products

Generic status & protection

Generic available — 7 ANDA applications approved.

Brands (NDA)

Generics (ANDA)

Listed patents

Presentations

Originator applications

Brand (NDA) products

LOCOIDRLD

BAUSCHNDA 0220762007

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.1%	LOTION	TOPICAL	Discontinued	—

LOCOID LIPOCREAMRLDRS

PRECISION DERMATNDA 0207691997

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.1%	CREAM	TOPICAL	Rx	AB2

LOCOIDRLDRS

BAUSCHNDA 0191161987

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.1%	SOLUTION	TOPICAL	Rx	AT

LOCOIDRLD

PRECISION DERMATNDA 0186521982

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.1%	OINTMENT	TOPICAL	Discontinued	—

LOCOIDRLDRS

BAUSCHNDA 0185141982

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.1%	CREAM	TOPICAL	Rx	AB1

LOCOID

YAMANOUCHINDA 0198191988

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.1%	SOLUTION	TOPICAL	Discontinued	—

LOCOID

YAMANOUCHINDA 0191061984

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.1%	OINTMENT	TOPICAL	Discontinued	—

LOCOID

YAMANOUCHINDA 0187951983

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.1%	CREAM	TOPICAL	Discontinued	—

Abbreviated applications

Generic (ANDA) products (7)

HYDROCORTISONE BUTYRATERS

LUPINANDA 2102092018

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.1%	LOTION	TOPICAL	Rx	AB

HYDROCORTISONE BUTYRATE

ACTAVIS MID ATLANTICANDA 2051342017

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.1%	CREAM	TOPICAL	Rx	AB2

HYDROCORTISONE BUTYRATE

THE J MOLNERANDA 2095562017

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.1%	LOTION	TOPICAL	Rx	AB

HYDROCORTISONE BUTYRATE

GLENMARK PHARMS LTDANDA 2021452013

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.1%	CREAM	TOPICAL	Discontinued	—

HYDROCORTISONE BUTYRATE

TARO PHARM INDSANDA 0766542005

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.1%	CREAM	TOPICAL	Rx	AB1

HYDROCORTISONE BUTYRATERS

TAROANDA 0768422004

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.1%	OINTMENT	TOPICAL	Rx	—

HYDROCORTISONE BUTYRATE

TARO PHARM INDSANDA 0763642004

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.1%	SOLUTION	TOPICAL	Rx	AT

Orange Book patent file

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

FDA approval span

Approval history

First approval

Mar 31, 1982

44 yr 11 mo ago

Most recent approval

Aug 17, 2018

8 yr ago

Approvals span 1982–2018 across 15 FDA applications.

Brand (NDA) 853%

Generic (ANDA) 747%

Hydrocortisone butyrate — 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.

Related FDA reference tools

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

Book a Demo