Clobetasol Propionate
Clobetasol Propionate Ointment USP, 0.05% Rx only FOR TOPICAL DERMATOLOGIC USE ONLY NOT FOR OPHTHALMIC, ORAL OR INTRAVAGINAL USE.
Approved
Approval ID
1f076779-3f76-47d5-99f0-9b0b2d3f5fac
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 22, 2023
Manufacturers
FDA
Encube Ethicals Private Limited
DUNS: 915834105
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Clobetasol Propionate Ointment USP, 0.05%
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code21922-017
Application NumberANDA211295
Product Classification
M
Marketing Category
C73584
G
Generic Name
Clobetasol Propionate Ointment USP, 0.05%
Product Specifications
Route of AdministrationTOPICAL
Effective DateDecember 22, 2023
FDA Product Classification
INGREDIENTS (4)
CLOBETASOL PROPIONATEActive
Quantity: 0.5 mg in 1 g
Code: 779619577M
Classification: ACTIB
SORBITAN SESQUIOLEATEInactive
Code: 0W8RRI5W5A
Classification: IACT
PETROLATUMInactive
Code: 4T6H12BN9U
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT