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HYDROCORTISONE ACETATE

Hydrocortisone Acetate, 25 mg Rectal Suppositories

Approved
Approval ID

883ff13e-1717-402d-8410-79a5e72550eb

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jul 18, 2018

Manufacturers
FDA

Syntenza Pharmaceuticals LLC

DUNS: 080999747

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

HYDROCORTISONE ACETATE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code72056-010
Product Classification
G
Generic Name
HYDROCORTISONE ACETATE
Product Specifications
Route of AdministrationRECTAL
Effective DateJuly 18, 2018
FDA Product Classification

INGREDIENTS (2)

HYDROGENATED PALM KERNEL OILInactive
Code: FM8D1RE2VP
Classification: IACT
HYDROCORTISONE ACETATEActive
Quantity: 25 mg in 1 1
Code: 3X7931PO74
Classification: ACTIB

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HYDROCORTISONE ACETATE - FDA Drug Approval Details