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, CHEWABLE
Routes
ORAL
Active Ingredients

montelukast sodium 4 mg/1

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 71335-1602
Product ID 71335-1602_640b5606-8295-4f8d-9929-aedf2f51d227
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204093
Listing Expiration 2026-12-31
Marketing Start 2015-05-27

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 713351602
Hyphenated Format 71335-1602

Supplemental Identifiers

RxCUI
311759
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 ANDA204093 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 4 mg/1
source: ndc
Packaging
  • 30 TABLET, CHEWABLE in 1 BOTTLE (71335-1602-1)
  • 90 TABLET, CHEWABLE in 1 BOTTLE (71335-1602-2)
  • 60 TABLET, CHEWABLE in 1 BOTTLE (71335-1602-3)
source: ndc

Packages (3)

71335-1602-1 30 TABLET, CHEWABLE in 1 BOTTLE (71335-1602-1) 71335-1602-2 90 TABLET, CHEWABLE in 1 BOTTLE (71335-1602-2) 71335-1602-3 60 TABLET, CHEWABLE in 1 BOTTLE (71335-1602-3)

Ingredients (1)

montelukast sodium (4 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": "640b5606-8295-4f8d-9929-aedf2f51d227", "openfda": {"unii": ["U1O3J18SFL"], "rxcui": ["311759"], "spl_set_id": ["3ff4100f-11e3-4d6a-ab88-83bd605a1818"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, CHEWABLE in 1 BOTTLE (71335-1602-1)", "package_ndc": "71335-1602-1", "marketing_start_date": "20200513"}, {"sample": false, "description": "90 TABLET, CHEWABLE in 1 BOTTLE (71335-1602-2)", "package_ndc": "71335-1602-2", "marketing_start_date": "20200513"}, {"sample": false, "description": "60 TABLET, CHEWABLE in 1 BOTTLE (71335-1602-3)", "package_ndc": "71335-1602-3", "marketing_start_date": "20220214"}], "brand_name": "montelukast sodium", "product_id": "71335-1602_640b5606-8295-4f8d-9929-aedf2f51d227", "dosage_form": "TABLET, CHEWABLE", "pharm_class": ["Leukotriene Receptor Antagonist [EPC]", "Leukotriene Receptor Antagonists [MoA]"], "product_ndc": "71335-1602", "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": "4 mg/1"}], "application_number": "ANDA204093", "marketing_category": "ANDA", "marketing_start_date": "20150527", "listing_expiration_date": "20261231"}