montelukast sodium

Generic: montelukast sodium

Labeler: bryant ranch prepack
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name montelukast sodium
Generic Name montelukast sodium
Labeler bryant ranch prepack
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

montelukast sodium 10 mg/1

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 71335-1995
Product ID 71335-1995_b80634d9-520e-4dd5-920a-76445d9e0c87
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 713351995
Hyphenated Format 71335-1995

Supplemental Identifiers

RxCUI
200224
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 (71335-1995-1)
  • 4 TABLET, FILM COATED in 1 BOTTLE (71335-1995-2)
  • 7 TABLET, FILM COATED in 1 BOTTLE (71335-1995-3)
  • 60 TABLET, FILM COATED in 1 BOTTLE (71335-1995-4)
  • 10 TABLET, FILM COATED in 1 BOTTLE (71335-1995-5)
  • 90 TABLET, FILM COATED in 1 BOTTLE (71335-1995-6)
  • 120 TABLET, FILM COATED in 1 BOTTLE (71335-1995-7)
  • 15 TABLET, FILM COATED in 1 BOTTLE (71335-1995-8)
source: ndc

Packages (8)

71335-1995-1 30 TABLET, FILM COATED in 1 BOTTLE (71335-1995-1) 71335-1995-2 4 TABLET, FILM COATED in 1 BOTTLE (71335-1995-2) 71335-1995-3 7 TABLET, FILM COATED in 1 BOTTLE (71335-1995-3) 71335-1995-4 60 TABLET, FILM COATED in 1 BOTTLE (71335-1995-4) 71335-1995-5 10 TABLET, FILM COATED in 1 BOTTLE (71335-1995-5) 71335-1995-6 90 TABLET, FILM COATED in 1 BOTTLE (71335-1995-6) 71335-1995-7 120 TABLET, FILM COATED in 1 BOTTLE (71335-1995-7) 71335-1995-8 15 TABLET, FILM COATED in 1 BOTTLE (71335-1995-8)

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": "b80634d9-520e-4dd5-920a-76445d9e0c87", "openfda": {"unii": ["U1O3J18SFL"], "rxcui": ["200224"], "spl_set_id": ["9beb1510-f3af-4269-a9d0-e2bd41ac369b"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (71335-1995-1)", "package_ndc": "71335-1995-1", "marketing_start_date": "20211216"}, {"sample": false, "description": "4 TABLET, FILM COATED in 1 BOTTLE (71335-1995-2)", "package_ndc": "71335-1995-2", "marketing_start_date": "20240403"}, {"sample": false, "description": "7 TABLET, FILM COATED in 1 BOTTLE (71335-1995-3)", "package_ndc": "71335-1995-3", "marketing_start_date": "20240403"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (71335-1995-4)", "package_ndc": "71335-1995-4", "marketing_start_date": "20220509"}, {"sample": false, "description": "10 TABLET, FILM COATED in 1 BOTTLE (71335-1995-5)", "package_ndc": "71335-1995-5", "marketing_start_date": "20240403"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (71335-1995-6)", "package_ndc": "71335-1995-6", "marketing_start_date": "20211208"}, {"sample": false, "description": "120 TABLET, FILM COATED in 1 BOTTLE (71335-1995-7)", "package_ndc": "71335-1995-7", "marketing_start_date": "20240403"}, {"sample": false, "description": "15 TABLET, FILM COATED in 1 BOTTLE (71335-1995-8)", "package_ndc": "71335-1995-8", "marketing_start_date": "20240403"}], "brand_name": "montelukast sodium", "product_id": "71335-1995_b80634d9-520e-4dd5-920a-76445d9e0c87", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Leukotriene Receptor Antagonist [EPC]", "Leukotriene Receptor Antagonists [MoA]"], "product_ndc": "71335-1995", "generic_name": "montelukast sodium", "labeler_name": "Bryant Ranch Prepack", "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"}