MedPath
FDA Approval

Hydrocortisone Acetate

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

FDA Approval Summary

Company
Bryant Ranch Prepack
DUNS: 171714327
Effective Date
February 2, 2023
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL

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 Acetate

Product Details

NDC Product Code
63629-1994
Route of Administration
RECTAL
Effective Date
October 19, 2021
Code: 3X7931PO74Class: ACTIBQuantity: 25 mg in 1 1
C10-18 TRIGLYCERIDESInactive
Code: 43AGM4PHPIClass: IACT
© Copyright 2025. All Rights Reserved by MedPath