Betamethasone Dipropionate
BETAMETHASONE DIPROPIONATE CREAM USP (AUGMENTED*), 0.05% (potency expressed as betamethasone) * Vehicle augments the penetration of the steroid.
Approved
Approval ID
a8017f39-202d-41dd-957c-42309571c8b4
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 1, 2021
Manufacturers
FDA
Proficient Rx LP
DUNS: 079196022
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 Code63187-286
Application NumberANDA076215
Product Classification
M
Marketing Category
C73584
G
Generic Name
Betamethasone dipropionate
Product Specifications
Route of AdministrationTOPICAL
Effective DateJanuary 1, 2021
FDA Product Classification
INGREDIENTS (12)
CHLOROCRESOLInactive
Code: 36W53O7109
Classification: IACT
BETAMETHASONE DIPROPIONATEActive
Quantity: 0.5 mg in 1 g
Code: 826Y60901U
Classification: ACTIM
PETROLATUMInactive
Code: 4T6H12BN9U
Classification: IACT
WHITE WAXInactive
Code: 7G1J5DA97F
Classification: IACT
CETEARETH-30Inactive
Code: 1R9DCZ5FOX
Classification: IACT
GLYCERYL OLEATEInactive
Code: 4PC054V79P
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)Inactive
Code: 4Q93RCW27E
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
CYCLOMETHICONEInactive
Code: NMQ347994Z
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT