Last Updated: September 24, 2026

Details for New Drug Application (NDA): 089682

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NDA 089682 describes HYDROCORTISONE, which is a drug marketed by Actavis Mid Atlantic, Alpharma Us Pharms, Altana, Ambix, Chartwell Molecular, Encube, Everylife, Fougera Pharms Inc, G And W Labs, Ingram Pharm, Ivax Pharms, Naska, Padagis Us, Perrigo New York, Pharmaderm, Pharmafair, Rising, Stiefel, Syosset, Taro, Teva, Topiderm, Usl Pharma, Whiteworth Town Plsn, Teva Pharms, Fougera Pharms, Mericon, Sun Pharma Canada, Paddock Llc, Appco, Aurobindo Pharma Ltd, Barr, Elkins Sinn, Ferrante, Hibrow Hlthcare, Hikma Intl Pharms, Impax Labs, Impax Labs Inc, Inwood Labs, Nexgen Pharma Inc, Novitium Pharma, Panray, Parke Davis, Purepac Pharm, Roxane, Sandoz, Strides Pharma, Strides Pharma Intl, Watson Labs, Cenci, Imperium, Bel Mar, Epic Pharma Llc, Fera Pharms, X Gen Pharms, Genus, Bausch And Lomb, Cosette Pharms Nc, Wockhardt, Glenmark Pharms Ltd, Taro Pharm Inds, Lupin, The J Molner, Cmp Pharma Inc, Abraxis Pharm, Apotex, Baxter Hlthcare, Cipla, Intl Medication, Zydus Pharms, Encube Ethicals, and Padagis Israel, and is included in one hundred and thirty-nine NDAs. It is available from thirty-one suppliers. Additional details are available on the HYDROCORTISONE profile page.

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

Summary for 089682

Tradename:	HYDROCORTISONE
Applicant:	Actavis Mid Atlantic
Ingredient:	hydrocortisone
Patents:	0

Pharmacology for NDA: 089682

Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Medical Subject Heading (MeSH) Categories for 089682

Anti-Inflammatory Agents

Suppliers and Packaging for NDA: 089682

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
HYDROCORTISONE	hydrocortisone	CREAM;TOPICAL	089682	ANDA	A-S Medication Solutions	50090-5999	50090-5999-0	1 TUBE in 1 CARTON (50090-5999-0) / 20 g in 1 TUBE
HYDROCORTISONE	hydrocortisone	CREAM;TOPICAL	089682	ANDA	Proficient Rx LP	63187-480	63187-480-20	1 TUBE in 1 CARTON (63187-480-20) / 20 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CREAM;TOPICAL			Strength	2.5%
Approval Date:	Mar 10, 1988	TE:		RLD:	No

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