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Hydrocortisone Acetate

Hydrocortisone Acetate Suppositories

Approved
Approval ID

7c1d2c8c-26e2-432f-b983-505f259665a9

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Dec 22, 2021

Manufacturers
FDA

Patrin Pharma Inc.

DUNS: 806841677

Products 2

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 Code39328-029
Product Classification
G
Generic Name
Hydrocortisone Acetate
Product Specifications
Route of AdministrationRECTAL
Effective DateDecember 22, 2021
FDA Product Classification

INGREDIENTS (2)

HYDROCORTISONE ACETATEActive
Quantity: 25 mg in 1 1
Code: 3X7931PO74
Classification: ACTIB
HYDROGENATED PALM OILInactive
Code: 257THB963H
Classification: IACT

Hydrocortisone Acetate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code39328-129
Product Classification
G
Generic Name
Hydrocortisone Acetate
Product Specifications
Route of AdministrationRECTAL
Effective DateDecember 22, 2021
FDA Product Classification

INGREDIENTS (2)

HYDROCORTISONE ACETATEActive
Quantity: 30 mg in 1 1
Code: 3X7931PO74
Classification: ACTIB
HYDROGENATED PALM OILInactive
Code: 257THB963H
Classification: IACT

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Hydrocortisone Acetate - FDA Drug Approval Details