MedPath

Mometasone Furoate

MOMETASONE FUROATE LOTION (MOMETASONE FUROATE TOPICAL SOLUTION USP 0.1%)

Approved
Approval ID

5839e534-ab67-4303-a20f-2861030b5170

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Nov 5, 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.

Mometasone Furoate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code54868-3757
Application NumberANDA075919
Product Classification
M
Marketing Category
C73584
G
Generic Name
Mometasone Furoate
Product Specifications
Route of AdministrationTOPICAL
Effective DateSeptember 1, 2011
FDA Product Classification

INGREDIENTS (8)

MOMETASONE FUROATEActive
Quantity: 1 mg in 1 mL
Code: 04201GDN4R
Classification: ACTIB
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
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

MedPath

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

© 2025 MedPath, Inc. All rights reserved.

Mometasone Furoate - FDA Drug Approval Details