Clobetasol Propionate
These highlights do not include all the information needed to use safely and effectively. See full prescribing information for . Initial U.S. Approval: 1985
Approved
Approval ID
a178bb79-c0dc-4561-93df-8f7bd9d57bae
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 12, 2024
Manufacturers
FDA
Bryant Ranch Prepack
DUNS: 171714327
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 Code63629-9460
Application NumberANDA077763
Product Classification
M
Marketing Category
C73584
G
Generic Name
Clobetasol propionate
Product Specifications
Route of AdministrationTOPICAL
Effective DateOctober 31, 2022
FDA Product Classification
INGREDIENTS (7)
CLOBETASOL PROPIONATEActive
Quantity: 0.5 mg in 1 g
Code: 779619577M
Classification: ACTIB
CETYL ALCOHOLInactive
Code: 936JST6JCN
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
POLYSORBATE 60Inactive
Code: CAL22UVI4M
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
STEARYL ALCOHOLInactive
Code: 2KR89I4H1Y
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT