montelukast sodium

Generic: montelukast sodium

Labeler: avkare
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name montelukast sodium
Generic Name montelukast sodium
Labeler avkare
Dosage Form TABLET, CHEWABLE
Routes
ORAL
Active Ingredients

montelukast sodium 5 mg/1

Manufacturer
AvKARE

Identifiers & Regulatory

Product NDC 42291-623
Product ID 42291-623_4617d4b7-780e-f9ce-e063-6294a90aa00b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA200405
Listing Expiration 2026-12-31
Marketing Start 2013-01-04

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42291623
Hyphenated Format 42291-623

Supplemental Identifiers

RxCUI
200224 242438 311759
UPC
0342291623101 0342291623309
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 ANDA200405 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 1000 TABLET, CHEWABLE in 1 BOTTLE (42291-623-10)
  • 30 TABLET, CHEWABLE in 1 BOTTLE (42291-623-30)
  • 90 TABLET, CHEWABLE in 1 BOTTLE (42291-623-90)
source: ndc

Packages (3)

42291-623-10 1000 TABLET, CHEWABLE in 1 BOTTLE (42291-623-10) 42291-623-30 30 TABLET, CHEWABLE in 1 BOTTLE (42291-623-30) 42291-623-90 90 TABLET, CHEWABLE in 1 BOTTLE (42291-623-90)

Ingredients (1)

montelukast sodium (5 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": "4617d4b7-780e-f9ce-e063-6294a90aa00b", "openfda": {"upc": ["0342291623101", "0342291623309"], "unii": ["U1O3J18SFL"], "rxcui": ["200224", "242438", "311759"], "spl_set_id": ["ed2caffa-a75c-1c27-ae30-2d8280eaea7d"], "manufacturer_name": ["AvKARE"]}, "finished": true, "packaging": [{"sample": false, "description": "1000 TABLET, CHEWABLE in 1 BOTTLE (42291-623-10)", "package_ndc": "42291-623-10", "marketing_start_date": "20160804"}, {"sample": false, "description": "30 TABLET, CHEWABLE in 1 BOTTLE (42291-623-30)", "package_ndc": "42291-623-30", "marketing_start_date": "20130104"}, {"sample": false, "description": "90 TABLET, CHEWABLE in 1 BOTTLE (42291-623-90)", "package_ndc": "42291-623-90", "marketing_start_date": "20130104"}], "brand_name": "Montelukast Sodium", "product_id": "42291-623_4617d4b7-780e-f9ce-e063-6294a90aa00b", "dosage_form": "TABLET, CHEWABLE", "pharm_class": ["Leukotriene Receptor Antagonist [EPC]", "Leukotriene Receptor Antagonists [MoA]"], "product_ndc": "42291-623", "generic_name": "Montelukast Sodium", "labeler_name": "AvKARE", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Montelukast Sodium", "active_ingredients": [{"name": "MONTELUKAST SODIUM", "strength": "5 mg/1"}], "application_number": "ANDA200405", "marketing_category": "ANDA", "marketing_start_date": "20130104", "listing_expiration_date": "20261231"}