Montelukast
These highlights do not include all the information needed to use MONTELUKAST SODIUM safely and effectively. See full prescribing information for MONTELUKAST SODIUM. Initial U.S. Approval: 1998
Approved
Approval ID
6d69e73a-76cb-4ece-9cf9-e9adb4f523b4
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 31, 2021
Manufacturers
FDA
Sandoz Inc
DUNS: 005387188
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Montelukast
PRODUCT DETAILS
NDC Product Code0781-5560
Application NumberANDA200889
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateMarch 31, 2021
Generic NameMontelukast
INGREDIENTS (11)
MONTELUKAST SODIUMActive
Quantity: 10 mg in 1 1
Code: U1O3J18SFL
Classification: ACTIM
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OH
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
Montelukast
PRODUCT DETAILS
NDC Product Code0781-5554
Application NumberANDA091414
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateMarch 31, 2021
Generic NameMontelukast
INGREDIENTS (15)
MONTELUKAST SODIUMActive
Quantity: 4 mg in 1 1
Code: U1O3J18SFL
Classification: ACTIM
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
ASPARTAMEInactive
Code: Z0H242BBR1
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OH
Classification: IACT
MALTODEXTRINInactive
Code: 7CVR7L4A2D
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
LECITHIN, SOYBEANInactive
Code: 1DI56QDM62
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
LACTIC ACID, UNSPECIFIED FORMInactive
Code: 33X04XA5AT
Classification: IACT
Montelukast
PRODUCT DETAILS
NDC Product Code0781-5555
Application NumberANDA091414
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateMarch 31, 2021
Generic NameMontelukast
INGREDIENTS (15)
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
ASPARTAMEInactive
Code: Z0H242BBR1
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
MONTELUKAST SODIUMActive
Quantity: 5 mg in 1 1
Code: U1O3J18SFL
Classification: ACTIM
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OH
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
LACTIC ACID, UNSPECIFIED FORMInactive
Code: 33X04XA5AT
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
MALTODEXTRINInactive
Code: 7CVR7L4A2D
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
LECITHIN, SOYBEANInactive
Code: 1DI56QDM62
Classification: IACT
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT