montelukast

Generic: montelukast

Labeler: xlcare pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name montelukast
Generic Name montelukast
Labeler xlcare pharmaceuticals inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

montelukast sodium 10 mg/1

Manufacturer
XLCare Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 72865-175
Product ID 72865-175_f26fa301-e121-03c1-e053-2a95a90ab2e1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202843
Listing Expiration 2026-12-31
Marketing Start 2021-02-11

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72865175
Hyphenated Format 72865-175

Supplemental Identifiers

RxCUI
200224
UPC
0372865175309
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 (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
  • 1000 TABLET, FILM COATED in 1 BOTTLE (72865-175-10)
  • 30 TABLET, FILM COATED in 1 BOTTLE (72865-175-30)
  • 90 TABLET, FILM COATED in 1 BOTTLE (72865-175-90)
source: ndc

Packages (3)

72865-175-10 1000 TABLET, FILM COATED in 1 BOTTLE (72865-175-10) 72865-175-30 30 TABLET, FILM COATED in 1 BOTTLE (72865-175-30) 72865-175-90 90 TABLET, FILM COATED in 1 BOTTLE (72865-175-90)

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": "f26fa301-e121-03c1-e053-2a95a90ab2e1", "openfda": {"upc": ["0372865175309"], "unii": ["U1O3J18SFL"], "rxcui": ["200224"], "spl_set_id": ["82d65eea-c7c9-4e16-9176-46c43f00f0f6"], "manufacturer_name": ["XLCare Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (72865-175-10)", "package_ndc": "72865-175-10", "marketing_start_date": "20210211"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (72865-175-30)", "package_ndc": "72865-175-30", "marketing_start_date": "20210211"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (72865-175-90)", "package_ndc": "72865-175-90", "marketing_start_date": "20210211"}], "brand_name": "Montelukast", "product_id": "72865-175_f26fa301-e121-03c1-e053-2a95a90ab2e1", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Leukotriene Receptor Antagonist [EPC]", "Leukotriene Receptor Antagonists [MoA]"], "product_ndc": "72865-175", "generic_name": "Montelukast", "labeler_name": "XLCare Pharmaceuticals Inc.", "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": "20210211", "listing_expiration_date": "20261231"}