montelukast sodium

Generic: montelukast sodium

Labeler: direct_rx
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name montelukast sodium
Generic Name montelukast sodium
Labeler direct_rx
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

montelukast sodium 10 mg/1

Manufacturer
Direct_Rx

Identifiers & Regulatory

Product NDC 72189-418
Product ID 72189-418_2c4d0d3f-0096-e010-e063-6294a90a1ae9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202843
Listing Expiration 2026-12-31
Marketing Start 2023-02-02

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72189418
Hyphenated Format 72189-418

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 ANDA202843 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (72189-418-30)
  • 90 TABLET, FILM COATED in 1 BOTTLE (72189-418-90)
source: ndc

Packages (2)

72189-418-30 30 TABLET, FILM COATED in 1 BOTTLE (72189-418-30) 72189-418-90 90 TABLET, FILM COATED in 1 BOTTLE (72189-418-90)

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": "2c4d0d3f-0096-e010-e063-6294a90a1ae9", "openfda": {"unii": ["U1O3J18SFL"], "rxcui": ["200224"], "spl_set_id": ["f3bdf2a3-d661-5128-e053-2995a90a4661"], "manufacturer_name": ["Direct_Rx"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (72189-418-30)", "package_ndc": "72189-418-30", "marketing_start_date": "20230202"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (72189-418-90)", "package_ndc": "72189-418-90", "marketing_start_date": "20230202"}], "brand_name": "MONTELUKAST SODIUM", "product_id": "72189-418_2c4d0d3f-0096-e010-e063-6294a90a1ae9", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Leukotriene Receptor Antagonist [EPC]", "Leukotriene Receptor Antagonists [MoA]"], "product_ndc": "72189-418", "generic_name": "MONTELUKAST SODIUM", "labeler_name": "Direct_Rx", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "MONTELUKAST SODIUM", "active_ingredients": [{"name": "MONTELUKAST SODIUM", "strength": "10 mg/1"}], "application_number": "ANDA202843", "marketing_category": "ANDA", "marketing_start_date": "20230202", "listing_expiration_date": "20261231"}