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FDA Approval

Hydrocortisone Acetate

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

FDA Approval Summary

Company
Effective Date
January 18, 2023
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL

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 Acetate

Product Details

NDC Product Code
50090-6331
Route of Administration
RECTAL
Effective Date
February 12, 2020
HYDROGENATED PALM KERNEL OILInactive
Code: FM8D1RE2VPClass: IACT
Code: 3X7931PO74Class: ACTIBQuantity: 25 mg in 1 1
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