Betamethasone dipropionate
Betamethasone Dipropionate Cream USP, 0.05%(Potency expressed as betamethasone)FOR DERMATOLOGIC USE ONLY.NOT FOR OPHTHALMIC USE.
Approved
Approval ID
395d40c0-22d9-48d1-8d8e-eeaddf33c53e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 24, 2022
Manufacturers
FDA
Northstar Rx LLC.
DUNS: 830546433
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Betamethasone dipropionate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code16714-996
Application NumberANDA208885
Product Classification
M
Marketing Category
C73584
G
Generic Name
Betamethasone dipropionate
Product Specifications
Route of AdministrationTOPICAL
Effective DateNovember 24, 2022
FDA Product Classification
INGREDIENTS (8)
CETETH-20Inactive
Code: I835H2IHHX
Classification: IACT
BETAMETHASONE DIPROPIONATEActive
Quantity: 0.5 mg in 1 g
Code: 826Y60901U
Classification: ACTIM
CETOSTEARYL ALCOHOLInactive
Code: 2DMT128M1S
Classification: IACT
CHLOROCRESOLInactive
Code: 36W53O7109
Classification: IACT
MINERAL OILInactive
Code: T5L8T28FGP
Classification: IACT
PETROLATUMInactive
Code: 4T6H12BN9U
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM PHOSPHATE, MONOBASICInactive
Code: 3980JIH2SW
Classification: IACT