Betamethasone Dipropionate
BETAMETHASONE DIPROPIONATE OINTMENT USP, 0.05% (potency expressed as betamethasone) For Dermatologic Use Only – Not for Ophthalmic Use Rx Only
Approved
Approval ID
389cdebb-55fe-4808-a5b7-0f293d9ee45d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 14, 2010
Manufacturers
FDA
Rebel Distributors Corp.
DUNS: 118802834
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 Code21695-614
Application NumberANDA071012
Product Classification
M
Marketing Category
C73584
G
Generic Name
Betamethasone Dipropionate
Product Specifications
Route of AdministrationTOPICAL
Effective DateMarch 30, 2009
FDA Product Classification
INGREDIENTS (3)
PETROLATUMInactive
Code: 4T6H12BN9U
Classification: IACT
Betamethasone DipropionateActive
Quantity: 0.05 mg in 1 g
Code: 826Y60901U
Classification: ACTIB
mineral oilInactive
Code: T5L8T28FGP
Classification: IACT