montelukast sodium

Generic: montelukast sodium

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

Drug Facts

Product Profile

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

montelukast sodium 10 mg/1

Manufacturer
NuCare Pharmaceuticals,Inc.

Identifiers & Regulatory

Product NDC 68071-5278
Product ID 68071-5278_2a80536c-27fd-0142-e063-6294a90a458f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204290
Listing Expiration 2026-12-31
Marketing Start 2016-01-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 680715278
Hyphenated Format 68071-5278

Supplemental Identifiers

RxCUI
200224
UPC
0368071527834
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 sodium (source: ndc)
Generic Name montelukast sodium (source: ndc)
Application Number ANDA204290 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (68071-5278-3)
source: ndc

Packages (1)

68071-5278-3 30 TABLET, FILM COATED in 1 BOTTLE (68071-5278-3)

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": "2a80536c-27fd-0142-e063-6294a90a458f", "openfda": {"upc": ["0368071527834"], "unii": ["U1O3J18SFL"], "rxcui": ["200224"], "spl_set_id": ["a7c11cbe-0834-27a5-e053-2995a90ac43f"], "manufacturer_name": ["NuCare Pharmaceuticals,Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (68071-5278-3)", "package_ndc": "68071-5278-3", "marketing_start_date": "20200610"}], "brand_name": "montelukast sodium", "product_id": "68071-5278_2a80536c-27fd-0142-e063-6294a90a458f", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Leukotriene Receptor Antagonist [EPC]", "Leukotriene Receptor Antagonists [MoA]"], "product_ndc": "68071-5278", "generic_name": "montelukast sodium", "labeler_name": "NuCare Pharmaceuticals,Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "montelukast sodium", "active_ingredients": [{"name": "MONTELUKAST SODIUM", "strength": "10 mg/1"}], "application_number": "ANDA204290", "marketing_category": "ANDA", "marketing_start_date": "20160101", "listing_expiration_date": "20261231"}