MedPath
FDA Approval

Hydrocortisone

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.
DUNS: 043838424
Effective Date
January 8, 2020
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Hydrocortisone(25 mg in 1 g)

Products2

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
0168-0146
Application Number
ANDA081203
Marketing Category
ANDA (C73584)
Route of Administration
TOPICAL
Effective Date
July 10, 2014
mineral oilInactive
Code: T5L8T28FGPClass: IACT
petrolatumInactive
Code: 4T6H12BN9UClass: IACT
Code: WI4X0X7BPJClass: ACTIBQuantity: 25 mg in 1 g

Hydrocortisone

Product Details

NDC Product Code
0168-0080
Application Number
ANDA089414
Marketing Category
ANDA (C73584)
Route of Administration
TOPICAL
Effective Date
July 10, 2014
Code: WI4X0X7BPJClass: ACTIBQuantity: 25 mg in 1 g
potassium sorbateInactive
Code: 1VPU26JZZ4Class: IACT
glycerinInactive
Code: PDC6A3C0OXClass: IACT
benzyl alcoholInactive
Code: LKG8494WBHClass: IACT
waterInactive
Code: 059QF0KO0RClass: IACT
isopropyl palmitateInactive
Code: 8CRQ2TH63MClass: IACT
paraffinInactive
Code: I9O0E3H2ZEClass: IACT
stearyl alcoholInactive
Code: 2KR89I4H1YClass: IACT
glyceryl monostearateInactive
Code: 230OU9XXE4Class: IACT
polyoxyl 40 stearateInactive
Code: 13A4J4NH9IClass: IACT
sorbitan monostearateInactive
Code: NVZ4I0H58XClass: IACT
LACTIC ACID, UNSPECIFIED FORMInactive
Code: 33X04XA5ATClass: IACT
© Copyright 2025. All Rights Reserved by MedPath