Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Unit Dose Services
Unit Dose Services
831995316
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
50436-2143Application Number
ANDA089414Marketing Category
ANDA (C73584)Route of Administration
TOPICALEffective Date
July 10, 2014HydrocortisoneActive
Code: WI4X0X7BPJClass: ACTIBQuantity: 25 mg in 1 g
potassium sorbateInactive
Code: 1VPU26JZZ4Class: IACT
benzyl alcoholInactive
Code: LKG8494WBHClass: IACT
paraffinInactive
Code: I9O0E3H2ZEClass: IACT
glycerinInactive
Code: PDC6A3C0OXClass: IACT
glyceryl monostearateInactive
Code: 230OU9XXE4Class: IACT
waterInactive
Code: 059QF0KO0RClass: IACT
isopropyl palmitateInactive
Code: 8CRQ2TH63MClass: IACT
stearyl alcoholInactive
Code: 2KR89I4H1YClass: IACT
sorbitan monostearateInactive
Code: NVZ4I0H58XClass: IACT
LACTIC ACID, UNSPECIFIED FORMInactive
Code: 33X04XA5ATClass: IACT
polyoxyl 40 stearateInactive
Code: 13A4J4NH9IClass: IACT