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FDA Approval

Hydrocortisone

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

FDA Approval Summary

Company
Effective Date
February 4, 2023
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Hydrocortisone(25 mg in 1 g)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

A-S Medication Solutions

A-S Medication Solutions

830016429

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
50090-0350
Application Number
ANDA085025
Marketing Category
ANDA (C73584)
Route of Administration
TOPICAL
Effective Date
December 22, 2016
Code: WI4X0X7BPJClass: ACTIBQuantity: 25 mg in 1 g
WATERInactive
Code: 059QF0KO0RClass: IACT
STEARYL ALCOHOLInactive
Code: 2KR89I4H1YClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
CETYL ALCOHOLInactive
Code: 936JST6JCNClass: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OHClass: IACT
METHYLPARABENInactive
Code: A2I8C7HI9TClass: IACT
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