Montelukast
MONTELUKAST SODIUM TABLETS. These highlights do not include all the information needed to use MONTELUKAST SODIUM TABLETS safely and effectively. See full prescribing information for MONTELUKAST SODIUM TABLETS. MONTELUKAST SODIUM tablets, for oral use Initial U.S. Approval: 1998
Approved
Approval ID
f5759a3b-8543-4472-e053-2995a90a24f5
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 29, 2023
Manufacturers
FDA
Pharmasource Meds, LLC
DUNS: 118772692
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Montelukast
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code82982-040
Application NumberANDA202843
Product Classification
M
Marketing Category
C73584
G
Generic Name
Montelukast
Product Specifications
Route of AdministrationORAL
Effective DateMarch 29, 2023
FDA Product Classification
INGREDIENTS (12)
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
MONTELUKAST SODIUMActive
Quantity: 10 mg in 1 1
Code: U1O3J18SFL
Classification: ACTIM