montelukast sodium

Generic: montelukast

Labeler: amneal pharmaceuticals llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name montelukast sodium
Generic Name montelukast
Labeler amneal pharmaceuticals llc
Dosage Form TABLET, CHEWABLE
Routes
ORAL
Active Ingredients

montelukast sodium 4 mg/1

Manufacturer
Amneal Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 65162-771
Product ID 65162-771_ed8a8093-3cde-44cf-9bdc-c8bc5fb9909c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205107
Listing Expiration 2026-12-31
Marketing Start 2020-09-04

Pharmacologic Class

Classes
leukotriene receptor antagonist [epc] leukotriene receptor antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65162771
Hyphenated Format 65162-771

Supplemental Identifiers

RxCUI
242438 311759
UNII
U1O3J18SFL

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name montelukast sodium (source: ndc)
Generic Name montelukast (source: ndc)
Application Number ANDA205107 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 4 mg/1
source: ndc
Packaging
  • 30 TABLET, CHEWABLE in 1 BOTTLE (65162-771-03)
source: ndc

Packages (1)

65162-771-03 30 TABLET, CHEWABLE in 1 BOTTLE (65162-771-03)

Ingredients (1)

montelukast sodium (4 mg/1)

Linked Drug Pages (1)

Montelukast Sodium ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "ed8a8093-3cde-44cf-9bdc-c8bc5fb9909c", "openfda": {"unii": ["U1O3J18SFL"], "rxcui": ["242438", "311759"], "spl_set_id": ["bcd49102-a21c-4628-a322-6cdd934e7f09"], "manufacturer_name": ["Amneal Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, CHEWABLE in 1 BOTTLE (65162-771-03)", "package_ndc": "65162-771-03", "marketing_start_date": "20200904"}], "brand_name": "Montelukast Sodium", "product_id": "65162-771_ed8a8093-3cde-44cf-9bdc-c8bc5fb9909c", "dosage_form": "TABLET, CHEWABLE", "pharm_class": ["Leukotriene Receptor Antagonist [EPC]", "Leukotriene Receptor Antagonists [MoA]"], "product_ndc": "65162-771", "generic_name": "Montelukast", "labeler_name": "Amneal Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Montelukast Sodium", "active_ingredients": [{"name": "MONTELUKAST SODIUM", "strength": "4 mg/1"}], "application_number": "ANDA205107", "marketing_category": "ANDA", "marketing_start_date": "20200904", "listing_expiration_date": "20261231"}