montelukast

Generic: montelukast

Labeler: nucare pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name montelukast
Generic Name montelukast
Labeler nucare pharmaceuticals, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

montelukast sodium 10 mg/1

Manufacturer
NuCare Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 68071-3855
Product ID 68071-3855_365e27d8-b610-c19e-e063-6394a90a3610
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203366
Listing Expiration 2026-12-31
Marketing Start 2014-09-11

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 680713855
Hyphenated Format 68071-3855

Supplemental Identifiers

RxCUI
200224
UPC
0368071385533
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 ANDA203366 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (68071-3855-3)
source: ndc

Packages (1)

68071-3855-3 30 TABLET in 1 BOTTLE (68071-3855-3)

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": "365e27d8-b610-c19e-e063-6394a90a3610", "openfda": {"upc": ["0368071385533"], "unii": ["U1O3J18SFL"], "rxcui": ["200224"], "spl_set_id": ["365e1c5c-01b2-bf4e-e063-6394a90a0e43"], "manufacturer_name": ["NuCare Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (68071-3855-3)", "package_ndc": "68071-3855-3", "marketing_start_date": "20250530"}], "brand_name": "Montelukast", "product_id": "68071-3855_365e27d8-b610-c19e-e063-6394a90a3610", "dosage_form": "TABLET", "pharm_class": ["Leukotriene Receptor Antagonist [EPC]", "Leukotriene Receptor Antagonists [MoA]"], "product_ndc": "68071-3855", "generic_name": "Montelukast", "labeler_name": "NuCare Pharmaceuticals, Inc.", "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": "20140911", "listing_expiration_date": "20261231"}