FDA Product

MONTELUKAST SODIUM

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Product Name

MONTELUKAST SODIUM

FDA Product Code

61919-097

Regulatory Information

NDC Product Code

61919-097

Application Number

ANDA090984

Marketing Category

C73584

Effective Date

January 21, 2020

Territorial Authority

USA

FDA Title

MONTELUKAST SODIUM

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

2

Company Information

ManufacturerDIRECT RX

DUNS Number

079254320

Active Ingredients

MONTELUKAST SODIUM

Quantity: 5 mg in 1 1

Code: U1O3J18SFL

Class Code: ACTIM

Inactive Ingredients

MANNITOL

Code: 3OWL53L36A

Class Code: IACT

FERRIC OXIDE RED

Code: 1K09F3G675

Class Code: IACT

CELLULOSE, MICROCRYSTALLINE

Code: OP1R32D61U

Class Code: IACT

CHERRY

Code: BUC5I9595W

Class Code: IACT

ASPARTAME

Code: Z0H242BBR1

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

CROSCARMELLOSE SODIUM

Code: M28OL1HH48

Class Code: IACT

Active Moieties

MONTELUKAST

Code: MHM278SD3E

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