montelukast sodium

Generic: montelukast sodium

Labeler: proficient rx lp
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name montelukast sodium
Generic Name montelukast sodium
Labeler proficient rx lp
Dosage Form TABLET, COATED
Routes
ORAL
Active Ingredients

montelukast sodium 10 mg/1

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 63187-692
Product ID 63187-692_51ba5811-a7f6-4c07-abde-873a75ba5554
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203432
Listing Expiration 2026-12-31
Marketing Start 2015-11-10

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63187692
Hyphenated Format 63187-692

Supplemental Identifiers

RxCUI
200224
UNII
U1O3J18SFL

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 ANDA203432 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 30 TABLET, COATED in 1 BOTTLE (63187-692-30)
  • 60 TABLET, COATED in 1 BOTTLE (63187-692-60)
  • 90 TABLET, COATED in 1 BOTTLE (63187-692-90)
source: ndc

Packages (3)

63187-692-30 30 TABLET, COATED in 1 BOTTLE (63187-692-30) 63187-692-60 60 TABLET, COATED in 1 BOTTLE (63187-692-60) 63187-692-90 90 TABLET, COATED in 1 BOTTLE (63187-692-90)

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": "51ba5811-a7f6-4c07-abde-873a75ba5554", "openfda": {"unii": ["U1O3J18SFL"], "rxcui": ["200224"], "spl_set_id": ["901385e5-7384-4c28-a36a-7dd84c36f5fd"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, COATED in 1 BOTTLE (63187-692-30)", "package_ndc": "63187-692-30", "marketing_start_date": "20160401"}, {"sample": false, "description": "60 TABLET, COATED in 1 BOTTLE (63187-692-60)", "package_ndc": "63187-692-60", "marketing_start_date": "20160401"}, {"sample": false, "description": "90 TABLET, COATED in 1 BOTTLE (63187-692-90)", "package_ndc": "63187-692-90", "marketing_start_date": "20160401"}], "brand_name": "MONTELUKAST SODIUM", "product_id": "63187-692_51ba5811-a7f6-4c07-abde-873a75ba5554", "dosage_form": "TABLET, COATED", "pharm_class": ["Leukotriene Receptor Antagonist [EPC]", "Leukotriene Receptor Antagonists [MoA]"], "product_ndc": "63187-692", "generic_name": "MONTELUKAST SODIUM", "labeler_name": "Proficient Rx LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "MONTELUKAST SODIUM", "active_ingredients": [{"name": "MONTELUKAST SODIUM", "strength": "10 mg/1"}], "application_number": "ANDA203432", "marketing_category": "ANDA", "marketing_start_date": "20151110", "listing_expiration_date": "20261231"}