montelukast sodium

Generic: montelukast sodium

Labeler: accord healthcare inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name montelukast sodium
Generic Name montelukast sodium
Labeler accord healthcare inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

montelukast sodium 10 mg/1

Manufacturer
Accord Healthcare Inc.

Identifiers & Regulatory

Product NDC 16729-119
Product ID 16729-119_d481e75b-ffed-a218-e053-2995a90a19c5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202717
Listing Expiration 2026-12-31
Marketing Start 2013-04-11

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 16729119
Hyphenated Format 16729-119

Supplemental Identifiers

RxCUI
200224
UPC
0316729119108
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 ANDA202717 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (16729-119-10)
  • 90 TABLET, FILM COATED in 1 BOTTLE (16729-119-15)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (16729-119-17)
source: ndc

Packages (3)

16729-119-10 30 TABLET, FILM COATED in 1 BOTTLE (16729-119-10) 16729-119-15 90 TABLET, FILM COATED in 1 BOTTLE (16729-119-15) 16729-119-17 1000 TABLET, FILM COATED in 1 BOTTLE (16729-119-17)

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": "d481e75b-ffed-a218-e053-2995a90a19c5", "openfda": {"upc": ["0316729119108"], "unii": ["U1O3J18SFL"], "rxcui": ["200224"], "spl_set_id": ["6eea668f-a2fa-447f-b2d5-4c754d13d9fa"], "manufacturer_name": ["Accord Healthcare Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (16729-119-10)", "package_ndc": "16729-119-10", "marketing_start_date": "20130611"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (16729-119-15)", "package_ndc": "16729-119-15", "marketing_start_date": "20130411"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (16729-119-17)", "package_ndc": "16729-119-17", "marketing_start_date": "20141120"}], "brand_name": "Montelukast Sodium", "product_id": "16729-119_d481e75b-ffed-a218-e053-2995a90a19c5", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Leukotriene Receptor Antagonist [EPC]", "Leukotriene Receptor Antagonists [MoA]"], "product_ndc": "16729-119", "generic_name": "Montelukast Sodium", "labeler_name": "Accord Healthcare Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Montelukast Sodium", "active_ingredients": [{"name": "MONTELUKAST SODIUM", "strength": "10 mg/1"}], "application_number": "ANDA202717", "marketing_category": "ANDA", "marketing_start_date": "20130411", "listing_expiration_date": "20261231"}