Last Updated: September 24, 2026

Details for New Drug Application (NDA): 076842

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NDA 076842 describes HYDROCORTISONE BUTYRATE, which is a drug marketed by Actavis Mid Atlantic, Glenmark Pharms Ltd, Taro Pharm Inds, Lupin, The J Molner, and Taro, and is included in seven NDAs. It is available from five suppliers. Additional details are available on the HYDROCORTISONE BUTYRATE profile page.

The generic ingredient in HYDROCORTISONE BUTYRATE is hydrocortisone butyrate. There is one drug master file entry for this compound. Six suppliers are listed for this compound. Additional details are available on the hydrocortisone butyrate profile page.

Summary for 076842

Tradename:	HYDROCORTISONE BUTYRATE
Applicant:	Taro
Ingredient:	hydrocortisone butyrate
Patents:	0

Pharmacology for NDA: 076842

Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Suppliers and Packaging for NDA: 076842

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
HYDROCORTISONE BUTYRATE	hydrocortisone butyrate	OINTMENT;TOPICAL	076842	ANDA	Sun Pharmaceutical Industries, Inc.	51672-4083	51672-4083-1	1 TUBE in 1 CARTON (51672-4083-1) / 15 g in 1 TUBE
HYDROCORTISONE BUTYRATE	hydrocortisone butyrate	OINTMENT;TOPICAL	076842	ANDA	Sun Pharmaceutical Industries, Inc.	51672-4083	51672-4083-2	1 TUBE in 1 CARTON (51672-4083-2) / 30 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	OINTMENT;TOPICAL			Strength	0.1%
Approval Date:	Dec 27, 2004	TE:		RLD:	No

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