montelukast sodium

Generic: montelukast sodium

Labeler: chartwell rx, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

montelukast sodium 4 mg/1

Manufacturer
Chartwell RX, LLC

Identifiers & Regulatory

Product NDC 62135-781
Product ID 62135-781_462a5e7c-f204-7e57-e063-6294a90a896e
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 62135781
Hyphenated Format 62135-781

Supplemental Identifiers

RxCUI
242438 311759
UPC
0362135781309 0362135782306
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
  • 4 mg/1
source: ndc
Packaging
  • 30 TABLET, CHEWABLE in 1 BOTTLE (62135-781-30)
source: ndc

Packages (1)

62135-781-30 30 TABLET, CHEWABLE in 1 BOTTLE (62135-781-30)

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": "462a5e7c-f204-7e57-e063-6294a90a896e", "openfda": {"upc": ["0362135781309", "0362135782306"], "unii": ["U1O3J18SFL"], "rxcui": ["242438", "311759"], "spl_set_id": ["5cb4298c-10b1-4d6f-95ad-4aad72daf249"], "manufacturer_name": ["Chartwell RX, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, CHEWABLE in 1 BOTTLE (62135-781-30)", "package_ndc": "62135-781-30", "marketing_start_date": "20231006"}], "brand_name": "MONTELUKAST SODIUM", "product_id": "62135-781_462a5e7c-f204-7e57-e063-6294a90a896e", "dosage_form": "TABLET, CHEWABLE", "pharm_class": ["Leukotriene Receptor Antagonist [EPC]", "Leukotriene Receptor Antagonists [MoA]"], "product_ndc": "62135-781", "generic_name": "MONTELUKAST SODIUM", "labeler_name": "Chartwell RX, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "MONTELUKAST SODIUM", "active_ingredients": [{"name": "MONTELUKAST SODIUM", "strength": "4 mg/1"}], "application_number": "ANDA200405", "marketing_category": "ANDA", "marketing_start_date": "20120803", "listing_expiration_date": "20261231"}