montelukast sodium

Generic: montelukast sodium

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

Drug Facts

Product Profile

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

montelukast sodium 10 mg/1

Manufacturer
Westminster Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 69367-287
Product ID 69367-287_1026f850-9f36-346f-e063-6394a90a2373
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205683
Listing Expiration 2026-12-31
Marketing Start 2016-05-30

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69367287
Hyphenated Format 69367-287

Supplemental Identifiers

RxCUI
200224
UPC
0369367287050
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 sodium (source: ndc)
Application Number ANDA205683 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 500 TABLET in 1 BOTTLE (69367-287-05)
  • 90 TABLET in 1 BOTTLE (69367-287-09)
source: ndc

Packages (2)

69367-287-05 500 TABLET in 1 BOTTLE (69367-287-05) 69367-287-09 90 TABLET in 1 BOTTLE (69367-287-09)

Ingredients (1)

montelukast sodium (10 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": "1026f850-9f36-346f-e063-6394a90a2373", "openfda": {"upc": ["0369367287050"], "unii": ["U1O3J18SFL"], "rxcui": ["200224"], "spl_set_id": ["c0daaaf3-6717-4a01-e053-2995a90af2d8"], "manufacturer_name": ["Westminster Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET in 1 BOTTLE (69367-287-05)", "package_ndc": "69367-287-05", "marketing_start_date": "20210425"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (69367-287-09)", "package_ndc": "69367-287-09", "marketing_start_date": "20210425"}], "brand_name": "Montelukast Sodium", "product_id": "69367-287_1026f850-9f36-346f-e063-6394a90a2373", "dosage_form": "TABLET", "pharm_class": ["Leukotriene Receptor Antagonist [EPC]", "Leukotriene Receptor Antagonists [MoA]"], "product_ndc": "69367-287", "generic_name": "Montelukast Sodium", "labeler_name": "Westminster Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Montelukast Sodium", "active_ingredients": [{"name": "MONTELUKAST SODIUM", "strength": "10 mg/1"}], "application_number": "ANDA205683", "marketing_category": "ANDA", "marketing_start_date": "20160530", "listing_expiration_date": "20261231"}