montelukast sodium

Generic: montelukast

Labeler: proficient rx lp
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name montelukast sodium
Generic Name montelukast
Labeler proficient rx lp
Dosage Form TABLET, CHEWABLE
Routes
ORAL
Active Ingredients

montelukast sodium 5 mg/1

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 71205-128
Product ID 71205-128_03b5d63d-1c2c-41db-8111-2dcf7e66f010
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203328
Listing Expiration 2026-12-31
Marketing Start 2015-08-13

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71205128
Hyphenated Format 71205-128

Supplemental Identifiers

RxCUI
242438
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 (source: ndc)
Application Number ANDA203328 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 30 TABLET, CHEWABLE in 1 BOTTLE (71205-128-30)
  • 60 TABLET, CHEWABLE in 1 BOTTLE (71205-128-60)
  • 90 TABLET, CHEWABLE in 1 BOTTLE (71205-128-90)
source: ndc

Packages (3)

71205-128-30 30 TABLET, CHEWABLE in 1 BOTTLE (71205-128-30) 71205-128-60 60 TABLET, CHEWABLE in 1 BOTTLE (71205-128-60) 71205-128-90 90 TABLET, CHEWABLE in 1 BOTTLE (71205-128-90)

Ingredients (1)

montelukast sodium (5 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": "03b5d63d-1c2c-41db-8111-2dcf7e66f010", "openfda": {"unii": ["U1O3J18SFL"], "rxcui": ["242438"], "spl_set_id": ["cab84c43-96a3-4868-88da-3126685edf00"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, CHEWABLE in 1 BOTTLE (71205-128-30)", "package_ndc": "71205-128-30", "marketing_start_date": "20181001"}, {"sample": false, "description": "60 TABLET, CHEWABLE in 1 BOTTLE (71205-128-60)", "package_ndc": "71205-128-60", "marketing_start_date": "20181001"}, {"sample": false, "description": "90 TABLET, CHEWABLE in 1 BOTTLE (71205-128-90)", "package_ndc": "71205-128-90", "marketing_start_date": "20181001"}], "brand_name": "MONTELUKAST SODIUM", "product_id": "71205-128_03b5d63d-1c2c-41db-8111-2dcf7e66f010", "dosage_form": "TABLET, CHEWABLE", "pharm_class": ["Leukotriene Receptor Antagonist [EPC]", "Leukotriene Receptor Antagonists [MoA]"], "product_ndc": "71205-128", "generic_name": "MONTELUKAST", "labeler_name": "Proficient Rx LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "MONTELUKAST SODIUM", "active_ingredients": [{"name": "MONTELUKAST SODIUM", "strength": "5 mg/1"}], "application_number": "ANDA203328", "marketing_category": "ANDA", "marketing_start_date": "20150813", "listing_expiration_date": "20261231"}