montelukast

Generic: montelukast

Labeler: sandoz inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name montelukast
Generic Name montelukast
Labeler sandoz inc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

montelukast sodium 10 mg/1

Manufacturer
Sandoz Inc

Identifiers & Regulatory

Product NDC 0781-5560
Product ID 0781-5560_e593fadb-cac5-44ca-8fd6-93c626cd40a7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA200889
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 07815560
Hyphenated Format 0781-5560

Supplemental Identifiers

RxCUI
200224
UPC
0307815560317
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 (source: ndc)
Generic Name montelukast (source: ndc)
Application Number ANDA200889 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 10 BLISTER PACK in 1 CARTON (0781-5560-13) / 10 TABLET, FILM COATED in 1 BLISTER PACK (0781-5560-06)
  • 30 TABLET, FILM COATED in 1 BOTTLE (0781-5560-31)
  • 90 TABLET, FILM COATED in 1 BOTTLE (0781-5560-92)
source: ndc

Packages (3)

0781-5560-13 10 BLISTER PACK in 1 CARTON (0781-5560-13) / 10 TABLET, FILM COATED in 1 BLISTER PACK (0781-5560-06) 0781-5560-31 30 TABLET, FILM COATED in 1 BOTTLE (0781-5560-31) 0781-5560-92 90 TABLET, FILM COATED in 1 BOTTLE (0781-5560-92)

Ingredients (1)

montelukast sodium (10 mg/1)

Linked Drug Pages (1)

Montelukast ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "e593fadb-cac5-44ca-8fd6-93c626cd40a7", "openfda": {"upc": ["0307815560317"], "unii": ["U1O3J18SFL"], "rxcui": ["200224"], "spl_set_id": ["6d69e73a-76cb-4ece-9cf9-e9adb4f523b4"], "manufacturer_name": ["Sandoz Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 BLISTER PACK in 1 CARTON (0781-5560-13)  / 10 TABLET, FILM COATED in 1 BLISTER PACK (0781-5560-06)", "package_ndc": "0781-5560-13", "marketing_start_date": "20250613"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (0781-5560-31)", "package_ndc": "0781-5560-31", "marketing_start_date": "20250613"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (0781-5560-92)", "package_ndc": "0781-5560-92", "marketing_start_date": "20250613"}], "brand_name": "Montelukast", "product_id": "0781-5560_e593fadb-cac5-44ca-8fd6-93c626cd40a7", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Leukotriene Receptor Antagonist [EPC]", "Leukotriene Receptor Antagonists [MoA]"], "product_ndc": "0781-5560", "generic_name": "Montelukast", "labeler_name": "Sandoz Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Montelukast", "active_ingredients": [{"name": "MONTELUKAST SODIUM", "strength": "10 mg/1"}], "application_number": "ANDA200889", "marketing_category": "ANDA", "marketing_start_date": "20120803", "listing_expiration_date": "20261231"}