montelukast sodium

Generic: montelukast sodium

Labeler: lannett company, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name montelukast sodium
Generic Name montelukast sodium
Labeler lannett company, inc.
Dosage Form TABLET, CHEWABLE
Routes
ORAL
Active Ingredients

montelukast sodium 5 mg/1

Manufacturer
Lannett Company, Inc.

Identifiers & Regulatory

Product NDC 62175-205
Product ID 62175-205_a4215d29-ef78-4b4d-9683-9dc4d35e345a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA200405
Listing Expiration 2026-12-31
Marketing Start 2012-08-03

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 62175205
Hyphenated Format 62175-205

Supplemental Identifiers

RxCUI
242438 311759
UPC
0362175205322 0362175204325
UNII
U1O3J18SFL

Packaging Origin

Original Packager
true

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 ANDA200405 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 30 TABLET, CHEWABLE in 1 BOTTLE (62175-205-32)
  • 1000 TABLET, CHEWABLE in 1 BOTTLE (62175-205-43)
  • 90 TABLET, CHEWABLE in 1 BOTTLE (62175-205-46)
source: ndc

Packages (3)

62175-205-32 30 TABLET, CHEWABLE in 1 BOTTLE (62175-205-32) 62175-205-43 1000 TABLET, CHEWABLE in 1 BOTTLE (62175-205-43) 62175-205-46 90 TABLET, CHEWABLE in 1 BOTTLE (62175-205-46)

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": "a4215d29-ef78-4b4d-9683-9dc4d35e345a", "openfda": {"upc": ["0362175205322", "0362175204325"], "unii": ["U1O3J18SFL"], "rxcui": ["242438", "311759"], "spl_set_id": ["c43d1edb-c162-4317-9a89-d84e4eff5512"], "manufacturer_name": ["Lannett Company, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, CHEWABLE in 1 BOTTLE (62175-205-32)", "package_ndc": "62175-205-32", "marketing_start_date": "20120803"}, {"sample": false, "description": "1000 TABLET, CHEWABLE in 1 BOTTLE (62175-205-43)", "package_ndc": "62175-205-43", "marketing_start_date": "20120803"}, {"sample": false, "description": "90 TABLET, CHEWABLE in 1 BOTTLE (62175-205-46)", "package_ndc": "62175-205-46", "marketing_start_date": "20120803"}], "brand_name": "Montelukast Sodium", "product_id": "62175-205_a4215d29-ef78-4b4d-9683-9dc4d35e345a", "dosage_form": "TABLET, CHEWABLE", "pharm_class": ["Leukotriene Receptor Antagonist [EPC]", "Leukotriene Receptor Antagonists [MoA]"], "product_ndc": "62175-205", "generic_name": "Montelukast Sodium", "labeler_name": "Lannett Company, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Montelukast Sodium", "active_ingredients": [{"name": "MONTELUKAST SODIUM", "strength": "5 mg/1"}], "application_number": "ANDA200405", "marketing_category": "ANDA", "marketing_start_date": "20120803", "listing_expiration_date": "20261231"}