MedPath

Betamethasone Dipropionate

BETAMETHASONE DIPROPIONATE LOTION USP 0.05% (AUGMENTED*) (potency expressed as betamethasone) * Vehicle augments the penetration of the steroid.

Approved
Approval ID

90d6c26b-3623-477e-afca-7028587bdf80

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jul 15, 2009

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 Code54868-6288
Application NumberANDA077111
Product Classification
M
Marketing Category
C73584
G
Generic Name
Betamethasone Dipropionate
Product Specifications
Route of AdministrationTOPICAL
Effective DateAugust 19, 2011
FDA Product Classification

INGREDIENTS (7)

isopropyl alcoholInactive
Code: ND2M416302
Classification: IACT
phosphoric acidInactive
Code: E4GA8884NN
Classification: IACT
betamethasone dipropionateActive
Quantity: 0.64 mg in 1 mL
Code: 826Y60901U
Classification: ACTIB
propylene glycolInactive
Code: 6DC9Q167V3
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
sodium phosphate, monobasicInactive
Code: 3980JIH2SW
Classification: IACT
hydroxypropyl celluloseInactive
Code: RFW2ET671P
Classification: IACT

MedPath

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

© 2025 MedPath, Inc. All rights reserved.

Betamethasone Dipropionate - FDA Drug Approval Details