montelukast

Generic: montelukast

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

Drug Facts

Product Profile

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

montelukast sodium 5 mg/1

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 63187-626
Product ID 63187-626_b54fe609-9c8c-4ca3-bd5c-8f3ab197f969
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203037
Listing Expiration 2026-12-31
Marketing Start 2014-12-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63187626
Hyphenated Format 63187-626

Supplemental Identifiers

RxCUI
242438
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 ANDA203037 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 30 TABLET, CHEWABLE in 1 BOTTLE (63187-626-30)
  • 60 TABLET, CHEWABLE in 1 BOTTLE (63187-626-60)
  • 90 TABLET, CHEWABLE in 1 BOTTLE (63187-626-90)
source: ndc

Packages (3)

63187-626-30 30 TABLET, CHEWABLE in 1 BOTTLE (63187-626-30) 63187-626-60 60 TABLET, CHEWABLE in 1 BOTTLE (63187-626-60) 63187-626-90 90 TABLET, CHEWABLE in 1 BOTTLE (63187-626-90)

Ingredients (1)

montelukast sodium (5 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": "b54fe609-9c8c-4ca3-bd5c-8f3ab197f969", "openfda": {"unii": ["U1O3J18SFL"], "rxcui": ["242438"], "spl_set_id": ["9705627c-283e-4743-b261-cfeb88d96e9b"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, CHEWABLE in 1 BOTTLE (63187-626-30)", "package_ndc": "63187-626-30", "marketing_start_date": "20181201"}, {"sample": false, "description": "60 TABLET, CHEWABLE in 1 BOTTLE (63187-626-60)", "package_ndc": "63187-626-60", "marketing_start_date": "20181201"}, {"sample": false, "description": "90 TABLET, CHEWABLE in 1 BOTTLE (63187-626-90)", "package_ndc": "63187-626-90", "marketing_start_date": "20181201"}], "brand_name": "MONTELUKAST", "product_id": "63187-626_b54fe609-9c8c-4ca3-bd5c-8f3ab197f969", "dosage_form": "TABLET, CHEWABLE", "pharm_class": ["Leukotriene Receptor Antagonist [EPC]", "Leukotriene Receptor Antagonists [MoA]"], "product_ndc": "63187-626", "generic_name": "MONTELUKAST", "labeler_name": "Proficient Rx LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "MONTELUKAST", "active_ingredients": [{"name": "MONTELUKAST SODIUM", "strength": "5 mg/1"}], "application_number": "ANDA203037", "marketing_category": "ANDA", "marketing_start_date": "20141201", "listing_expiration_date": "20261231"}