Montelukast Sodium
These highlights do not include all the information needed to use MONTELUKAST SODIUM CHEWABLE TABLETS safely and effectively. See full prescribing information for MONTELUKAST SODIUM CHEWABLE TABLETS. Montelukast Sodium Chewable Tablets, for oral use Initial U.S. Approval: 1998
Approved
Approval ID
2e207413-342a-4a7c-b9dd-881e6cd927cf
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 12, 2015
Manufacturers
FDA
Hangzhou Minsheng Binjiang Pharmaceutical CO., Ltd.
DUNS: 547688780
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Montelukast Sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code60723-004
Application NumberANDA205695
Product Classification
M
Marketing Category
C73584
G
Generic Name
Montelukast Sodium
Product Specifications
Route of AdministrationORAL
Effective DateNovember 12, 2015
FDA Product Classification
INGREDIENTS (10)
COLLOIDAL SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
ASPARTAMEInactive
Code: Z0H242BBR1
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYDROXYPROPYL CELLULOSE (TYPE EL)Inactive
Code: 8VAB711C5E
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MONTELUKAST SODIUMActive
Quantity: 4 mg in 1 1
Code: U1O3J18SFL
Classification: ACTIM
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
Montelukast Sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code60723-005
Application NumberANDA205695
Product Classification
M
Marketing Category
C73584
G
Generic Name
Montelukast Sodium
Product Specifications
Route of AdministrationORAL
Effective DateNovember 12, 2015
FDA Product Classification
INGREDIENTS (10)
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
COLLOIDAL SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
ASPARTAMEInactive
Code: Z0H242BBR1
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MONTELUKAST SODIUMActive
Quantity: 5 mg in 1 1
Code: U1O3J18SFL
Classification: ACTIM
HYDROXYPROPYL CELLULOSE (TYPE EL)Inactive
Code: 8VAB711C5E
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT