montelukast sodium

Generic: montelukast sodium

Labeler: a-s medication solutions
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name montelukast sodium
Generic Name montelukast sodium
Labeler a-s medication solutions
Dosage Form TABLET, CHEWABLE
Routes
ORAL
Active Ingredients

montelukast 4 mg/1

Manufacturer
A-S Medication Solutions

Identifiers & Regulatory

Product NDC 50090-2921
Product ID 50090-2921_6ff28499-c368-47ee-98d8-4d8e4bf77d84
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204093
Listing Expiration 2026-12-31
Marketing Start 2015-05-27

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 500902921
Hyphenated Format 50090-2921

Supplemental Identifiers

RxCUI
311759
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
  • 4 mg/1
source: ndc
Packaging
  • 30 TABLET, CHEWABLE in 1 BOTTLE (50090-2921-0)
  • 90 TABLET, CHEWABLE in 1 BOTTLE (50090-2921-1)
source: ndc

Packages (2)

50090-2921-0 30 TABLET, CHEWABLE in 1 BOTTLE (50090-2921-0) 50090-2921-1 90 TABLET, CHEWABLE in 1 BOTTLE (50090-2921-1)

Ingredients (1)

montelukast (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": "6ff28499-c368-47ee-98d8-4d8e4bf77d84", "openfda": {"nui": ["N0000175777", "N0000000083"], "unii": ["MHM278SD3E"], "rxcui": ["311759"], "spl_set_id": ["25b2049d-3a93-4ac3-8de6-14f5d7ce0315"], "pharm_class_epc": ["Leukotriene Receptor Antagonist [EPC]"], "pharm_class_moa": ["Leukotriene Receptor Antagonists [MoA]"], "manufacturer_name": ["A-S Medication Solutions"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, CHEWABLE in 1 BOTTLE (50090-2921-0)", "package_ndc": "50090-2921-0", "marketing_start_date": "20170315"}, {"sample": false, "description": "90 TABLET, CHEWABLE in 1 BOTTLE (50090-2921-1)", "package_ndc": "50090-2921-1", "marketing_start_date": "20181005"}], "brand_name": "montelukast sodium", "product_id": "50090-2921_6ff28499-c368-47ee-98d8-4d8e4bf77d84", "dosage_form": "TABLET, CHEWABLE", "pharm_class": ["Leukotriene Receptor Antagonist [EPC]", "Leukotriene Receptor Antagonists [MoA]"], "product_ndc": "50090-2921", "generic_name": "montelukast sodium", "labeler_name": "A-S Medication Solutions", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "montelukast sodium", "active_ingredients": [{"name": "MONTELUKAST", "strength": "4 mg/1"}], "application_number": "ANDA204093", "marketing_category": "ANDA", "marketing_start_date": "20150527", "listing_expiration_date": "20261231"}