Last Updated: September 24, 2026

Details for New Drug Application (NDA): 075043

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NDA 075043 describes HYDROCORTISONE VALERATE, which is a drug marketed by Cosette Pharms Nc, Encube Ethicals, Glenmark Pharms Ltd, Lupin, Padagis Israel, Sun Pharma Canada, and Fougera Pharms, and is included in eleven NDAs. It is available from six suppliers. Additional details are available on the HYDROCORTISONE VALERATE profile page.

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

Summary for 075043

Tradename:	HYDROCORTISONE VALERATE
Applicant:	Sun Pharma Canada
Ingredient:	hydrocortisone valerate
Patents:	0

Pharmacology for NDA: 075043

Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Suppliers and Packaging for NDA: 075043

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
HYDROCORTISONE VALERATE	hydrocortisone valerate	OINTMENT;TOPICAL	075043	ANDA	Sun Pharmaceutical Industries, Inc.	51672-1292	51672-1292-1	1 TUBE in 1 CARTON (51672-1292-1) / 15 g in 1 TUBE
HYDROCORTISONE VALERATE	hydrocortisone valerate	OINTMENT;TOPICAL	075043	ANDA	Sun Pharmaceutical Industries, Inc.	51672-1292	51672-1292-3	1 TUBE in 1 CARTON (51672-1292-3) / 60 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	OINTMENT;TOPICAL			Strength	0.2%
Approval Date:	Aug 25, 1998	TE:	AB	RLD:	No

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