montelukast

Generic: montelukast

Labeler: a-s medication solutions
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name montelukast
Generic Name montelukast
Labeler a-s medication solutions
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

montelukast sodium 10 mg/1

Manufacturer
A-S Medication Solutions

Identifiers & Regulatory

Product NDC 50090-6108
Product ID 50090-6108_eeb0e0ae-31b8-4954-ac31-de5c082b18eb
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202843
Listing Expiration 2026-12-31
Marketing Start 2014-09-10

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 500906108
Hyphenated Format 50090-6108

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 (source: ndc)
Generic Name montelukast (source: ndc)
Application Number ANDA202843 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (50090-6108-0)
  • 90 TABLET, FILM COATED in 1 BOTTLE (50090-6108-1)
source: ndc

Packages (2)

50090-6108-0 30 TABLET, FILM COATED in 1 BOTTLE (50090-6108-0) 50090-6108-1 90 TABLET, FILM COATED in 1 BOTTLE (50090-6108-1)

Ingredients (1)

montelukast sodium (10 mg/1)

Linked Drug Pages (1)

Montelukast ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "eeb0e0ae-31b8-4954-ac31-de5c082b18eb", "openfda": {"unii": ["U1O3J18SFL"], "rxcui": ["200224"], "spl_set_id": ["6741830f-5d90-4066-bc3b-065059bc150d"], "manufacturer_name": ["A-S Medication Solutions"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (50090-6108-0)", "package_ndc": "50090-6108-0", "marketing_start_date": "20220928"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (50090-6108-1)", "package_ndc": "50090-6108-1", "marketing_start_date": "20220928"}], "brand_name": "Montelukast", "product_id": "50090-6108_eeb0e0ae-31b8-4954-ac31-de5c082b18eb", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Leukotriene Receptor Antagonist [EPC]", "Leukotriene Receptor Antagonists [MoA]"], "product_ndc": "50090-6108", "generic_name": "Montelukast", "labeler_name": "A-S Medication Solutions", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Montelukast", "active_ingredients": [{"name": "MONTELUKAST SODIUM", "strength": "10 mg/1"}], "application_number": "ANDA202843", "marketing_category": "ANDA", "marketing_start_date": "20140910", "listing_expiration_date": "20261231"}