montelukast sodium

Generic: montelukast

Labeler: amneal pharmaceuticals llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name montelukast sodium
Generic Name montelukast
Labeler amneal pharmaceuticals llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

montelukast sodium 10 mg/1

Manufacturer
Amneal Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 65162-732
Product ID 65162-732_ce5720a0-a4c1-4532-8112-53201502c0eb
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204604
Listing Expiration 2026-12-31
Marketing Start 2013-07-31

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65162732
Hyphenated Format 65162-732

Supplemental Identifiers

RxCUI
200224
UPC
0365162732115 0365162732092
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 (source: ndc)
Application Number ANDA204604 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (65162-732-03)
  • 90 TABLET in 1 BOTTLE (65162-732-09)
  • 1000 TABLET in 1 BOTTLE (65162-732-11)
source: ndc

Packages (3)

65162-732-03 30 TABLET in 1 BOTTLE (65162-732-03) 65162-732-09 90 TABLET in 1 BOTTLE (65162-732-09) 65162-732-11 1000 TABLET in 1 BOTTLE (65162-732-11)

Ingredients (1)

montelukast sodium (10 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": "ce5720a0-a4c1-4532-8112-53201502c0eb", "openfda": {"upc": ["0365162732115", "0365162732092"], "unii": ["U1O3J18SFL"], "rxcui": ["200224"], "spl_set_id": ["ccbbf0d6-efd9-4fdd-9e7b-e3d293062609"], "manufacturer_name": ["Amneal Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (65162-732-03)", "package_ndc": "65162-732-03", "marketing_start_date": "20130731"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (65162-732-09)", "package_ndc": "65162-732-09", "marketing_start_date": "20130731"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (65162-732-11)", "package_ndc": "65162-732-11", "marketing_start_date": "20130731"}], "brand_name": "Montelukast Sodium", "product_id": "65162-732_ce5720a0-a4c1-4532-8112-53201502c0eb", "dosage_form": "TABLET", "pharm_class": ["Leukotriene Receptor Antagonist [EPC]", "Leukotriene Receptor Antagonists [MoA]"], "product_ndc": "65162-732", "generic_name": "Montelukast", "labeler_name": "Amneal Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Montelukast Sodium", "active_ingredients": [{"name": "MONTELUKAST SODIUM", "strength": "10 mg/1"}], "application_number": "ANDA204604", "marketing_category": "ANDA", "marketing_start_date": "20130731", "listing_expiration_date": "20261231"}