montelukast sodium

Generic: montelukast sodium

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name montelukast sodium
Generic Name montelukast sodium
Labeler aurobindo pharma limited
Dosage Form GRANULE
Routes
ORAL
Active Ingredients

montelukast sodium 4 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 59651-329
Product ID 59651-329_2fcb1880-c88e-4c82-829e-6177a07814c4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213471
Listing Expiration 2026-12-31
Marketing Start 2020-02-18

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 59651329
Hyphenated Format 59651-329

Supplemental Identifiers

RxCUI
351246
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 ANDA213471 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 4 mg/1
source: ndc
Packaging
  • 30 PACKET in 1 CARTON (59651-329-30) / 1 GRANULE in 1 PACKET (59651-329-05)
source: ndc

Packages (1)

59651-329-30 30 PACKET in 1 CARTON (59651-329-30) / 1 GRANULE in 1 PACKET (59651-329-05)

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": "2fcb1880-c88e-4c82-829e-6177a07814c4", "openfda": {"unii": ["U1O3J18SFL"], "rxcui": ["351246"], "spl_set_id": ["9a3bfc59-0ca6-4433-abf5-41659bfe0a8f"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 PACKET in 1 CARTON (59651-329-30)  / 1 GRANULE in 1 PACKET (59651-329-05)", "package_ndc": "59651-329-30", "marketing_start_date": "20200218"}], "brand_name": "Montelukast Sodium", "product_id": "59651-329_2fcb1880-c88e-4c82-829e-6177a07814c4", "dosage_form": "GRANULE", "pharm_class": ["Leukotriene Receptor Antagonist [EPC]", "Leukotriene Receptor Antagonists [MoA]"], "product_ndc": "59651-329", "generic_name": "Montelukast Sodium", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Montelukast Sodium", "active_ingredients": [{"name": "MONTELUKAST SODIUM", "strength": "4 mg/1"}], "application_number": "ANDA213471", "marketing_category": "ANDA", "marketing_start_date": "20200218", "listing_expiration_date": "20261231"}