montelukast

Generic: montelukast

Labeler: legacy pharmaceutical packaging, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name montelukast
Generic Name montelukast
Labeler legacy pharmaceutical packaging, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

montelukast sodium 10 mg/1

Manufacturer
Legacy Pharmaceutical Packaging, LLC

Identifiers & Regulatory

Product NDC 68645-560
Product ID 68645-560_474399e6-7a3d-2d8a-e063-6294a90a7692
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202843
Listing Expiration 2026-12-31
Marketing Start 2014-09-10

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68645560
Hyphenated Format 68645-560

Supplemental Identifiers

RxCUI
200224
UPC
0368645560540
UNII
U1O3J18SFL

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 ANDA202843 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (68645-560-54)
source: ndc

Packages (1)

68645-560-54 30 TABLET, FILM COATED in 1 BOTTLE (68645-560-54)

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": "474399e6-7a3d-2d8a-e063-6294a90a7692", "openfda": {"upc": ["0368645560540"], "unii": ["U1O3J18SFL"], "rxcui": ["200224"], "spl_set_id": ["b7182fd7-c018-401d-ad24-c0a2cc8d1c58"], "manufacturer_name": ["Legacy Pharmaceutical Packaging, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (68645-560-54)", "package_ndc": "68645-560-54", "marketing_start_date": "20140910"}], "brand_name": "Montelukast", "product_id": "68645-560_474399e6-7a3d-2d8a-e063-6294a90a7692", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Leukotriene Receptor Antagonist [EPC]", "Leukotriene Receptor Antagonists [MoA]"], "product_ndc": "68645-560", "generic_name": "Montelukast", "labeler_name": "Legacy Pharmaceutical Packaging, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Montelukast", "active_ingredients": [{"name": "MONTELUKAST SODIUM", "strength": "10 mg/1"}], "application_number": "ANDA202843", "marketing_category": "ANDA", "marketing_start_date": "20140910", "listing_expiration_date": "20261231"}