MedPath

Betamethasone Dipropionate

Betamethasone Dipropionate Cream, 0.05% (Augmented*)

Approved
Approval ID

cadb8d68-5fe6-471d-9d14-5bda6034b802

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Mar 1, 2011

Manufacturers
FDA

Physicians Total Care, Inc.

DUNS: 194123980

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 Code54868-6292
Application NumberANDA078930
Product Classification
M
Marketing Category
C73584
G
Generic Name
Betamethasone Dipropionate
Product Specifications
Route of AdministrationTOPICAL
Effective DateOctober 3, 2011
FDA Product Classification

INGREDIENTS (10)

PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
BETAMETHASONE DIPROPIONATEActive
Quantity: 0.5 mg in 1 g
Code: 826Y60901U
Classification: ACTIB
CHLOROCRESOLInactive
Code: 36W53O7109
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
WHITE WAXInactive
Code: 7G1J5DA97F
Classification: IACT
PETROLATUMInactive
Code: 4T6H12BN9U
Classification: IACT
CARBOMER HOMOPOLYMER TYPE CInactive
Code: 4Q93RCW27E
Classification: IACT
CYCLOMETHICONEInactive
Code: NMQ347994Z
Classification: IACT
CETEARETH-30Inactive
Code: 1R9DCZ5FOX
Classification: IACT

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.