montelukast sodium

Generic: montelukast sodium

Labeler: macleods pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name montelukast sodium
Generic Name montelukast sodium
Labeler macleods pharmaceuticals limited
Dosage Form TABLET, CHEWABLE
Routes
ORAL
Active Ingredients

montelukast 5 mg/1

Manufacturer
Macleods Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 33342-111
Product ID 33342-111_a12af8c6-41af-4850-b725-4f8226b35b67
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203582
Listing Expiration 2026-12-31
Marketing Start 2015-03-13

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 33342111
Hyphenated Format 33342-111

Supplemental Identifiers

RxCUI
242438 311759
UPC
0333342110077 0333342111074
UNII
MHM278SD3E
NUI
N0000175777 N0000000083

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 ANDA203582 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 30 TABLET, CHEWABLE in 1 BOTTLE (33342-111-07)
  • 90 TABLET, CHEWABLE in 1 BOTTLE (33342-111-10)
  • 100 TABLET, CHEWABLE in 1 BLISTER PACK (33342-111-12)
  • 500 TABLET, CHEWABLE in 1 BOTTLE (33342-111-15)
  • 90 TABLET, CHEWABLE in 1 BLISTER PACK (33342-111-39)
  • 1000 TABLET, CHEWABLE in 1 BOTTLE (33342-111-44)
source: ndc

Packages (6)

33342-111-07 30 TABLET, CHEWABLE in 1 BOTTLE (33342-111-07) 33342-111-10 90 TABLET, CHEWABLE in 1 BOTTLE (33342-111-10) 33342-111-12 100 TABLET, CHEWABLE in 1 BLISTER PACK (33342-111-12) 33342-111-15 500 TABLET, CHEWABLE in 1 BOTTLE (33342-111-15) 33342-111-39 90 TABLET, CHEWABLE in 1 BLISTER PACK (33342-111-39) 33342-111-44 1000 TABLET, CHEWABLE in 1 BOTTLE (33342-111-44)

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": "a12af8c6-41af-4850-b725-4f8226b35b67", "openfda": {"nui": ["N0000175777", "N0000000083"], "upc": ["0333342110077", "0333342111074"], "unii": ["MHM278SD3E"], "rxcui": ["242438", "311759"], "spl_set_id": ["ce512844-5220-4661-809f-56d088699c9c"], "pharm_class_epc": ["Leukotriene Receptor Antagonist [EPC]"], "pharm_class_moa": ["Leukotriene Receptor Antagonists [MoA]"], "manufacturer_name": ["Macleods Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, CHEWABLE in 1 BOTTLE (33342-111-07)", "package_ndc": "33342-111-07", "marketing_start_date": "20150313"}, {"sample": false, "description": "90 TABLET, CHEWABLE in 1 BOTTLE (33342-111-10)", "package_ndc": "33342-111-10", "marketing_start_date": "20150313"}, {"sample": false, "description": "100 TABLET, CHEWABLE in 1 BLISTER PACK (33342-111-12)", "package_ndc": "33342-111-12", "marketing_start_date": "20150313"}, {"sample": false, "description": "500 TABLET, CHEWABLE in 1 BOTTLE (33342-111-15)", "package_ndc": "33342-111-15", "marketing_start_date": "20150313"}, {"sample": false, "description": "90 TABLET, CHEWABLE in 1 BLISTER PACK (33342-111-39)", "package_ndc": "33342-111-39", "marketing_start_date": "20150313"}, {"sample": false, "description": "1000 TABLET, CHEWABLE in 1 BOTTLE (33342-111-44)", "package_ndc": "33342-111-44", "marketing_start_date": "20150925"}], "brand_name": "Montelukast sodium", "product_id": "33342-111_a12af8c6-41af-4850-b725-4f8226b35b67", "dosage_form": "TABLET, CHEWABLE", "pharm_class": ["Leukotriene Receptor Antagonist [EPC]", "Leukotriene Receptor Antagonists [MoA]"], "product_ndc": "33342-111", "generic_name": "Montelukast sodium", "labeler_name": "Macleods Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Montelukast sodium", "active_ingredients": [{"name": "MONTELUKAST", "strength": "5 mg/1"}], "application_number": "ANDA203582", "marketing_category": "ANDA", "marketing_start_date": "20150313", "listing_expiration_date": "20261231"}