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Hydrocortisone Acetate

Hydrocortisone Acetate Suppositories, 25 mg For Rectal Administration Rx only

Approved
Approval ID

60dce400-1138-4781-b621-1774c0dbb64a

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

May 17, 2023

Manufacturers
FDA

QUAGEN PHARMACEUTICALS LLC

DUNS: 073645339

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

NDC Product Code70752-169
Application NumberN/A
Marketing CategoryN/A
Route of AdministrationRECTAL
Effective DateMay 17, 2023
Generic NameHydrocortisone Acetate

INGREDIENTS (2)

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

Drug Labeling Information

HOW SUPPLIED SECTION

LOINC: 34069-5Updated: 5/17/2023

HOW SUPPLIED

Hydrocortisone acetate suppositories 25 mg are white to off-white, smooth surfaced and bullet shaped with one pointed end.
Box of 12 suppositories, NDC 70752-169-02
Box of 24 suppositories, NDC 70752-169-23

STORAGE

Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature]. Excursions permitted to 15°-30°C (59°-86°F). Store away from heat. Protect from freezing. Avoid contact with eyes.

KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

Rx Only

Manufactured by:
Quagen Pharmaceuticals LLC
West Caldwell, NJ 07006

52030
Rev.01/21

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Hydrocortisone Acetate - FDA Drug Approval Details