montelukast sodium

Generic: montelukast sodium

Labeler: avpak
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name montelukast sodium
Generic Name montelukast sodium
Labeler avpak
Dosage Form TABLET, CHEWABLE
Routes
ORAL
Active Ingredients

montelukast sodium 4 mg/1

Manufacturer
AvPAK

Identifiers & Regulatory

Product NDC 50268-573
Product ID 50268-573_42525d29-7cfc-ee26-e063-6294a90a9f7c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA200405
Listing Expiration 2026-12-31
Marketing Start 2014-11-12

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50268573
Hyphenated Format 50268-573

Supplemental Identifiers

RxCUI
200224 242438 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 ANDA200405 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 4 mg/1
source: ndc
Packaging
  • 50 BLISTER PACK in 1 BOX (50268-573-15) / 1 TABLET, CHEWABLE in 1 BLISTER PACK (50268-573-11)
source: ndc

Packages (1)

50268-573-15 50 BLISTER PACK in 1 BOX (50268-573-15) / 1 TABLET, CHEWABLE in 1 BLISTER PACK (50268-573-11)

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": "42525d29-7cfc-ee26-e063-6294a90a9f7c", "openfda": {"unii": ["U1O3J18SFL"], "rxcui": ["200224", "242438", "311759"], "spl_set_id": ["2f90a573-27fd-cc16-f3d1-8c4d630224a0"], "manufacturer_name": ["AvPAK"]}, "finished": true, "packaging": [{"sample": false, "description": "50 BLISTER PACK in 1 BOX (50268-573-15)  / 1 TABLET, CHEWABLE in 1 BLISTER PACK (50268-573-11)", "package_ndc": "50268-573-15", "marketing_start_date": "20141112"}], "brand_name": "Montelukast Sodium", "product_id": "50268-573_42525d29-7cfc-ee26-e063-6294a90a9f7c", "dosage_form": "TABLET, CHEWABLE", "pharm_class": ["Leukotriene Receptor Antagonist [EPC]", "Leukotriene Receptor Antagonists [MoA]"], "product_ndc": "50268-573", "generic_name": "Montelukast Sodium", "labeler_name": "AvPAK", "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": "20141112", "listing_expiration_date": "20261231"}