MedPath

Clobetasol Propionate

Approved
Approval ID

c74a755b-b9a2-48cb-9387-f62a37a7a926

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Dec 28, 2010

Manufacturers
FDA

Physicians Total Care, Inc.

DUNS: 194123980

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 Code54868-3698
Application NumberANDA074248
Product Classification
M
Marketing Category
C73584
G
Generic Name
Clobetasol Propionate
Product Specifications
Route of AdministrationTOPICAL
Effective DateApril 28, 2011
FDA Product Classification

INGREDIENTS (4)

PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SORBITAN SESQUIOLEATEInactive
Code: 0W8RRI5W5A
Classification: IACT
PETROLATUMInactive
Code: 4T6H12BN9U
Classification: IACT
CLOBETASOL PROPIONATEActive
Quantity: 0.5 mg in 1 g
Code: 779619577M
Classification: ACTIB

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.

Clobetasol Propionate - FDA Drug Approval Details