Betamethasone Dipropionate
BETAMETHASONE DIPROPIONATE CREAM USP, 0.05%BETAMETHASONE DIPROPIONATE OINTMENT USP, 0.05%BETAMETHASONE DIPROPIONATE LOTION USP, 0.05%
Approved
Approval ID
668279da-ff19-47c9-84f7-267d27ad34f8
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 22, 2011
Manufacturers
FDA
H.J. Harkins Company, Inc.
DUNS: 147681894
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 Code52959-721
Application NumberANDA019137
Product Classification
M
Marketing Category
C73584
G
Generic Name
Betamethasone Dipropionate
Product Specifications
Route of AdministrationTOPICAL
Effective DateDecember 22, 2011
FDA Product Classification
INGREDIENTS (10)
betamethasone dipropionateActive
Quantity: 0.5 mg in 1 g
Code: 826Y60901U
Classification: ACTIM
ceteth-20Inactive
Code: I835H2IHHX
Classification: IACT
chlorocresolInactive
Code: 36W53O7109
Classification: IACT
cetostearyl alcoholInactive
Code: 2DMT128M1S
Classification: IACT
petrolatumInactive
Code: 4T6H12BN9U
Classification: IACT
mineral oilInactive
Code: T5L8T28FGP
Classification: IACT
sodium phosphate, monobasic, monohydrateInactive
Code: 593YOG76RN
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
phosphoric acidInactive
Code: E4GA8884NN
Classification: IACT
sodium hydroxideInactive
Code: 55X04QC32I
Classification: IACT