Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Bryant Ranch Prepack
171714327
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Bryant Ranch Prepack
Bryant Ranch Prepack
Bryant Ranch Prepack
171714327
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Hydrocortisone
Product Details
NDC Product Code
63629-8666Application Number
ANDA085025Marketing Category
ANDA (C73584)Route of Administration
TOPICALEffective Date
July 18, 2023WATERInactive
Code: 059QF0KO0RClass: IACT
STEARYL ALCOHOLInactive
Code: 2KR89I4H1YClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OHClass: IACT
METHYLPARABENInactive
Code: A2I8C7HI9TClass: IACT
CETYL ALCOHOLInactive
Code: 936JST6JCNClass: IACT
HydrocortisoneActive
Code: WI4X0X7BPJClass: ACTIBQuantity: 25 mg in 1 g