Montelukast Sodium

Basic Information

Product Name

Montelukast Sodium

FDA Product Code

65162-772

Regulatory Information

NDC Product Code

65162-772

Application Number

ANDA205107

Marketing Category

C73584

Effective Date

March 20, 2021

Territorial Authority

USA

FDA Title

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 useInitial U.S. Approval: 1998

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

MONTELUKAST SODIUM

Quantity: 5 mg in 1 1

Code: U1O3J18SFL

Class Code: ACTIM

ASPARTAME

Code: Z0H242BBR1

Class Code: IACT

CROSCARMELLOSE SODIUM

Code: M28OL1HH48

Class Code: IACT

HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED

Code: 2165RE0K14

Class Code: IACT

CELLULOSE, MICROCRYSTALLINE

Code: OP1R32D61U

Class Code: IACT

FERRIC OXIDE RED

Code: 1K09F3G675

Class Code: IACT

MANNITOL

Code: 3OWL53L36A

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

Active Moieties

MONTELUKAST

Code: MHM278SD3E

Basic Information

Regulatory Information

Company Information

Active Ingredients

ASPARTAME

CROSCARMELLOSE SODIUM

HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED

CELLULOSE, MICROCRYSTALLINE

FERRIC OXIDE RED

MANNITOL

MAGNESIUM STEARATE

Active Moieties

MONTELUKAST