Betamethasone Dipropionate
These highlights do not include all the information needed to use BETAMETHASONE DIPROPIONATE CREAM (augmented) safely and effectively. See full prescribing information for BETAMETHASONE DIPROPIONATE CREAM (augmented). BETAMETHASONE DIPROPIONATE cream, for topical use Initial U.S. Approval: 1983
Approved
Approval ID
000ae256-a337-4903-845b-003777a4efa8
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 6, 2021
Manufacturers
FDA
Taro Pharmaceuticals U.S.A., Inc.
DUNS: 145186370
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 Code51672-1310
Application NumberANDA076543
Product Classification
M
Marketing Category
C73584
G
Generic Name
Betamethasone Dipropionate
Product Specifications
Route of AdministrationTOPICAL
Effective DateDecember 1, 2020
FDA Product Classification
INGREDIENTS (12)
carbomer homopolymer type c (allyl pentaerythritol crosslinked)Inactive
Code: 4Q93RCW27E
Classification: IACT
ceteareth-30Inactive
Code: 1R9DCZ5FOX
Classification: IACT
Betamethasone DipropionateActive
Quantity: 0.5 mg in 1 g
Code: 826Y60901U
Classification: ACTIM
chlorocresolInactive
Code: 36W53O7109
Classification: IACT
cyclomethicone 5Inactive
Code: 0THT5PCI0R
Classification: IACT
glyceryl oleateInactive
Code: 4PC054V79P
Classification: IACT
propylene glycolInactive
Code: 6DC9Q167V3
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
sodium hydroxideInactive
Code: 55X04QC32I
Classification: IACT
petrolatumInactive
Code: 4T6H12BN9U
Classification: IACT
sorbitolInactive
Code: 506T60A25R
Classification: IACT
white waxInactive
Code: 7G1J5DA97F
Classification: IACT