montelukast sodium

Generic: montelukast sodium

Labeler: direct rx
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

montelukast 5 mg/1

Manufacturer
DIRECT RX

Identifiers & Regulatory

Product NDC 72189-223
Product ID 72189-223_2c283d75-2454-ee48-e063-6294a90a7651
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204093
Listing Expiration 2026-12-31
Marketing Start 2021-05-21

Pharmacologic Class

Established (EPC)
leukotriene receptor antagonist [epc]
Mechanism of Action
leukotriene receptor antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72189223
Hyphenated Format 72189-223

Supplemental Identifiers

RxCUI
242438
UNII
MHM278SD3E
NUI
N0000175777 N0000000083

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
  • 5 mg/1
source: ndc
Packaging
  • 30 TABLET, CHEWABLE in 1 BOTTLE (72189-223-30)
source: ndc

Packages (1)

72189-223-30 30 TABLET, CHEWABLE in 1 BOTTLE (72189-223-30)

Ingredients (1)

montelukast (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": "2c283d75-2454-ee48-e063-6294a90a7651", "openfda": {"nui": ["N0000175777", "N0000000083"], "unii": ["MHM278SD3E"], "rxcui": ["242438"], "spl_set_id": ["c2d834e6-7b38-d266-e053-2995a90a27ef"], "pharm_class_epc": ["Leukotriene Receptor Antagonist [EPC]"], "pharm_class_moa": ["Leukotriene Receptor Antagonists [MoA]"], "manufacturer_name": ["DIRECT RX"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, CHEWABLE in 1 BOTTLE (72189-223-30)", "package_ndc": "72189-223-30", "marketing_start_date": "20210521"}], "brand_name": "MONTELUKAST SODIUM", "product_id": "72189-223_2c283d75-2454-ee48-e063-6294a90a7651", "dosage_form": "TABLET, CHEWABLE", "pharm_class": ["Leukotriene Receptor Antagonist [EPC]", "Leukotriene Receptor Antagonists [MoA]"], "product_ndc": "72189-223", "generic_name": "MONTELUKAST SODIUM", "labeler_name": "DIRECT RX", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "MONTELUKAST SODIUM", "active_ingredients": [{"name": "MONTELUKAST", "strength": "5 mg/1"}], "application_number": "ANDA204093", "marketing_category": "ANDA", "marketing_start_date": "20210521", "listing_expiration_date": "20261231"}