montelukast

Generic: montelukast

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

Drug Facts

Product Profile

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

montelukast sodium 10 mg/1

Manufacturer
Preferred Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 68788-8099
Product ID 68788-8099_b29d7b77-d758-4b93-bf05-76cf2632d9cc
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202843
Listing Expiration 2026-12-31
Marketing Start 2021-10-06

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 687888099
Hyphenated Format 68788-8099

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 (68788-8099-3)
  • 60 TABLET, FILM COATED in 1 BOTTLE (68788-8099-6)
  • 90 TABLET, FILM COATED in 1 BOTTLE (68788-8099-9)
source: ndc

Packages (3)

68788-8099-3 30 TABLET, FILM COATED in 1 BOTTLE (68788-8099-3) 68788-8099-6 60 TABLET, FILM COATED in 1 BOTTLE (68788-8099-6) 68788-8099-9 90 TABLET, FILM COATED in 1 BOTTLE (68788-8099-9)

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": "b29d7b77-d758-4b93-bf05-76cf2632d9cc", "openfda": {"unii": ["U1O3J18SFL"], "rxcui": ["200224"], "spl_set_id": ["94642db1-5c75-44c4-92b4-8385b486df82"], "manufacturer_name": ["Preferred Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (68788-8099-3)", "package_ndc": "68788-8099-3", "marketing_start_date": "20211006"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (68788-8099-6)", "package_ndc": "68788-8099-6", "marketing_start_date": "20211006"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (68788-8099-9)", "package_ndc": "68788-8099-9", "marketing_start_date": "20211006"}], "brand_name": "Montelukast", "product_id": "68788-8099_b29d7b77-d758-4b93-bf05-76cf2632d9cc", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Leukotriene Receptor Antagonist [EPC]", "Leukotriene Receptor Antagonists [MoA]"], "product_ndc": "68788-8099", "generic_name": "Montelukast", "labeler_name": "Preferred 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": "20211006", "listing_expiration_date": "20261231"}