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 TABLET, CHEWABLE
Routes
ORAL
Active Ingredients

montelukast sodium 5 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 65862-568
Product ID 65862-568_035c2d56-5707-4d1e-96b8-7c9c2e848bb6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202096
Listing Expiration 2026-12-31
Marketing Start 2012-08-03

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65862568
Hyphenated Format 65862-568

Supplemental Identifiers

RxCUI
200224 242438 311759
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 ANDA202096 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 500 TABLET, CHEWABLE in 1 BOTTLE (65862-568-05)
  • 30 TABLET, CHEWABLE in 1 BOTTLE (65862-568-30)
  • 90 TABLET, CHEWABLE in 1 BOTTLE (65862-568-90)
source: ndc

Packages (3)

65862-568-05 500 TABLET, CHEWABLE in 1 BOTTLE (65862-568-05) 65862-568-30 30 TABLET, CHEWABLE in 1 BOTTLE (65862-568-30) 65862-568-90 90 TABLET, CHEWABLE in 1 BOTTLE (65862-568-90)

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": "035c2d56-5707-4d1e-96b8-7c9c2e848bb6", "openfda": {"unii": ["U1O3J18SFL"], "rxcui": ["200224", "242438", "311759"], "spl_set_id": ["ba42b0a9-83f1-4283-a853-f99cdd0761b9"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET, CHEWABLE in 1 BOTTLE (65862-568-05)", "package_ndc": "65862-568-05", "marketing_start_date": "20120803"}, {"sample": false, "description": "30 TABLET, CHEWABLE in 1 BOTTLE (65862-568-30)", "package_ndc": "65862-568-30", "marketing_start_date": "20120803"}, {"sample": false, "description": "90 TABLET, CHEWABLE in 1 BOTTLE (65862-568-90)", "package_ndc": "65862-568-90", "marketing_start_date": "20120803"}], "brand_name": "Montelukast Sodium", "product_id": "65862-568_035c2d56-5707-4d1e-96b8-7c9c2e848bb6", "dosage_form": "TABLET, CHEWABLE", "pharm_class": ["Leukotriene Receptor Antagonist [EPC]", "Leukotriene Receptor Antagonists [MoA]"], "product_ndc": "65862-568", "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": "5 mg/1"}], "application_number": "ANDA202096", "marketing_category": "ANDA", "marketing_start_date": "20120803", "listing_expiration_date": "20261231"}