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Clobetasol Propionate

Clobetasol Propionate Topical Solution, USP, 0.05% w/w

Approved
Approval ID

d2a1bcea-66db-4dd9-b586-7beef185a754

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Mar 11, 2022

Manufacturers
FDA

Akorn

DUNS: 117696873

Products 1

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

Clobetasol Propionate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code50383-266
Application NumberANDA074222
Product Classification
M
Marketing Category
C73584
G
Generic Name
Clobetasol Propionate
Product Specifications
Route of AdministrationTOPICAL
Effective DateMarch 11, 2022
FDA Product Classification

INGREDIENTS (5)

CLOBETASOL PROPIONATEActive
Quantity: 0.4625 mg in 1 mL
Code: 779619577M
Classification: ACTIB
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)Inactive
Code: HHT01ZNK31
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT

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Clobetasol Propionate - FDA Drug Approval Details