Mometasone Furoate
These highlights do not include all the information needed to use MOMETASONE FUROATE CREAM safely and effectively. See full prescribing information for MOMETASONE FUROATE CREAM. MOMETASONE FUROATE Cream, 0.1% for topical useInitial U.S. Approval: 1987
Approved
Approval ID
031283ed-988b-4698-8a2e-00f3d41c0f71
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 9, 2019
Manufacturers
FDA
Glenmark Pharmaceuticals Inc., USA
DUNS: 130597813
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 Code68462-192
Application NumberANDA078541
Product Classification
M
Marketing Category
C73584
G
Generic Name
Mometasone Furoate
Product Specifications
Route of AdministrationTOPICAL
Effective DateJuly 9, 2019
FDA Product Classification
INGREDIENTS (9)
ALUMINUM STARCH OCTENYLSUCCINATEInactive
Code: I9PJ0O6294
Classification: IACT
MOMETASONE FUROATEActive
Quantity: 1 mg in 1 g
Code: 04201GDN4R
Classification: ACTIB
HEXYLENE GLYCOLInactive
Code: KEH0A3F75J
Classification: IACT
HYDROGENATED SOYBEAN LECITHINInactive
Code: H1109Z9J4N
Classification: IACT
PHOSPHORIC ACIDInactive
Code: E4GA8884NN
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
PETROLATUMInactive
Code: 4T6H12BN9U
Classification: IACT
WHITE WAXInactive
Code: 7G1J5DA97F
Classification: IACT