Mometasone Furoate
These highlights do not include all the information needed to use safely and effectively. See full prescribing information for .MOMETASONE FUROATE ointment, for topical useInitial U.S. Approval: 1987
Approved
Approval ID
43a91066-1d85-4f67-9856-a11c1bb2b22b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 18, 2023
Manufacturers
FDA
Bryant Ranch Prepack
DUNS: 171714327
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 Code63629-8683
Application NumberANDA076067
Product Classification
M
Marketing Category
C73584
G
Generic Name
Mometasone Furoate
Product Specifications
Route of AdministrationTOPICAL
Effective DateJanuary 20, 2022
FDA Product Classification
INGREDIENTS (7)
PROPYLENE GLYCOL MONOSTEARATEInactive
Code: MZM1I680W0
Classification: IACT
MOMETASONE FUROATEActive
Quantity: 1 mg in 1 g
Code: 04201GDN4R
Classification: ACTIB
HEXYLENE GLYCOLInactive
Code: KEH0A3F75J
Classification: IACT
PHOSPHORIC ACIDInactive
Code: E4GA8884NN
Classification: IACT
PETROLATUMInactive
Code: 4T6H12BN9U
Classification: IACT
WHITE WAXInactive
Code: 7G1J5DA97F
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT