montelukast sodium

Generic: montelukast sodium

Labeler: ajanta pharma usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name montelukast sodium
Generic Name montelukast sodium
Labeler ajanta pharma usa inc.
Dosage Form TABLET, CHEWABLE
Routes
ORAL
Active Ingredients

montelukast sodium 4 mg/1

Manufacturer
Ajanta Pharma USA Inc.

Identifiers & Regulatory

Product NDC 27241-016
Product ID 27241-016_3e514c81-3941-446b-9b2d-024140da6f2e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203328
Listing Expiration 2026-12-31
Marketing Start 2015-08-13

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 27241016
Hyphenated Format 27241-016

Supplemental Identifiers

RxCUI
200224 242438 311759 351246
UPC
0327241016035 0327241016097 0327241018039 0327241018091 0327241017094 0327241015311 0327241017032
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 sodium (source: ndc)
Generic Name montelukast sodium (source: ndc)
Application Number ANDA203328 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 4 mg/1
source: ndc
Packaging
  • 30 TABLET, CHEWABLE in 1 BOTTLE (27241-016-03)
  • 90 TABLET, CHEWABLE in 1 BOTTLE (27241-016-09)
source: ndc

Packages (2)

27241-016-03 30 TABLET, CHEWABLE in 1 BOTTLE (27241-016-03) 27241-016-09 90 TABLET, CHEWABLE in 1 BOTTLE (27241-016-09)

Ingredients (1)

montelukast sodium (4 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": "3e514c81-3941-446b-9b2d-024140da6f2e", "openfda": {"upc": ["0327241016035", "0327241016097", "0327241018039", "0327241018091", "0327241017094", "0327241015311", "0327241017032"], "unii": ["U1O3J18SFL"], "rxcui": ["200224", "242438", "311759", "351246"], "spl_set_id": ["67070e4e-f755-46b3-b900-fcc1993a0546"], "manufacturer_name": ["Ajanta Pharma USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, CHEWABLE in 1 BOTTLE (27241-016-03)", "package_ndc": "27241-016-03", "marketing_start_date": "20150813"}, {"sample": false, "description": "90 TABLET, CHEWABLE in 1 BOTTLE (27241-016-09)", "package_ndc": "27241-016-09", "marketing_start_date": "20150813"}], "brand_name": "MONTELUKAST SODIUM", "product_id": "27241-016_3e514c81-3941-446b-9b2d-024140da6f2e", "dosage_form": "TABLET, CHEWABLE", "pharm_class": ["Leukotriene Receptor Antagonist [EPC]", "Leukotriene Receptor Antagonists [MoA]"], "product_ndc": "27241-016", "generic_name": "MONTELUKAST SODIUM", "labeler_name": "Ajanta Pharma USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "MONTELUKAST SODIUM", "active_ingredients": [{"name": "MONTELUKAST SODIUM", "strength": "4 mg/1"}], "application_number": "ANDA203328", "marketing_category": "ANDA", "marketing_start_date": "20150813", "listing_expiration_date": "20261231"}