montelukast

Generic: montelukast

Labeler: bluepoint laboratories
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name montelukast
Generic Name montelukast
Labeler bluepoint laboratories
Dosage Form TABLET
Routes
ORAL
Active Ingredients

montelukast sodium 10 mg/1

Manufacturer
BluePoint Laboratories

Identifiers & Regulatory

Product NDC 68001-361
Product ID 68001-361_d9dbbe03-bcc4-1af7-e053-2a95a90a8053
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203366
Listing Expiration 2026-12-31
Marketing Start 2018-06-29

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68001361
Hyphenated Format 68001-361

Supplemental Identifiers

RxCUI
200224
UPC
0368001361040 0368001361033 0368001361057
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 ANDA203366 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 500 TABLET in 1 BOTTLE (68001-361-03)
  • 30 TABLET in 1 BOTTLE (68001-361-04)
  • 90 TABLET in 1 BOTTLE (68001-361-05)
source: ndc

Packages (3)

68001-361-03 500 TABLET in 1 BOTTLE (68001-361-03) 68001-361-04 30 TABLET in 1 BOTTLE (68001-361-04) 68001-361-05 90 TABLET in 1 BOTTLE (68001-361-05)

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": "d9dbbe03-bcc4-1af7-e053-2a95a90a8053", "openfda": {"upc": ["0368001361040", "0368001361033", "0368001361057"], "unii": ["U1O3J18SFL"], "rxcui": ["200224"], "spl_set_id": ["4c411d3e-47b6-481b-b846-419ed4cbb947"], "manufacturer_name": ["BluePoint Laboratories"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET in 1 BOTTLE (68001-361-03)", "package_ndc": "68001-361-03", "marketing_start_date": "20180629"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (68001-361-04)", "package_ndc": "68001-361-04", "marketing_start_date": "20180629"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (68001-361-05)", "package_ndc": "68001-361-05", "marketing_start_date": "20180629"}], "brand_name": "Montelukast", "product_id": "68001-361_d9dbbe03-bcc4-1af7-e053-2a95a90a8053", "dosage_form": "TABLET", "pharm_class": ["Leukotriene Receptor Antagonist [EPC]", "Leukotriene Receptor Antagonists [MoA]"], "product_ndc": "68001-361", "generic_name": "Montelukast", "labeler_name": "BluePoint Laboratories", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Montelukast", "active_ingredients": [{"name": "MONTELUKAST SODIUM", "strength": "10 mg/1"}], "application_number": "ANDA203366", "marketing_category": "ANDA", "marketing_start_date": "20180629", "listing_expiration_date": "20261231"}