montelukast

Generic: montelukast

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

Drug Facts

Product Profile

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

montelukast sodium 10 mg/1

Manufacturer
Macleods Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 33342-102
Product ID 33342-102_c0c72c6c-cc59-47ba-9dfb-0af985ae7ea6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203366
Listing Expiration 2026-12-31
Marketing Start 2014-09-11

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 33342102
Hyphenated Format 33342-102

Supplemental Identifiers

RxCUI
200224
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 (source: ndc)
Generic Name montelukast (source: ndc)
Application Number ANDA203366 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (33342-102-07)
  • 90 TABLET in 1 BOTTLE (33342-102-10)
  • 100 TABLET in 1 BLISTER PACK (33342-102-12)
  • 500 TABLET in 1 BOTTLE (33342-102-15)
  • 90 TABLET in 1 BLISTER PACK (33342-102-39)
source: ndc

Packages (5)

33342-102-07 30 TABLET in 1 BOTTLE (33342-102-07) 33342-102-10 90 TABLET in 1 BOTTLE (33342-102-10) 33342-102-12 100 TABLET in 1 BLISTER PACK (33342-102-12) 33342-102-15 500 TABLET in 1 BOTTLE (33342-102-15) 33342-102-39 90 TABLET in 1 BLISTER PACK (33342-102-39)

Ingredients (1)

montelukast sodium (10 mg/1)

Linked Drug Pages (1)

Montelukast ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "c0c72c6c-cc59-47ba-9dfb-0af985ae7ea6", "openfda": {"unii": ["U1O3J18SFL"], "rxcui": ["200224"], "spl_set_id": ["e0c5b856-3f70-4ca6-9763-a90673bb82fb"], "manufacturer_name": ["Macleods Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (33342-102-07)", "package_ndc": "33342-102-07", "marketing_start_date": "20140911"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (33342-102-10)", "package_ndc": "33342-102-10", "marketing_start_date": "20140911"}, {"sample": false, "description": "100 TABLET in 1 BLISTER PACK (33342-102-12)", "package_ndc": "33342-102-12", "marketing_start_date": "20140911"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (33342-102-15)", "package_ndc": "33342-102-15", "marketing_start_date": "20140911"}, {"sample": false, "description": "90 TABLET in 1 BLISTER PACK (33342-102-39)", "package_ndc": "33342-102-39", "marketing_start_date": "20140911"}], "brand_name": "Montelukast", "product_id": "33342-102_c0c72c6c-cc59-47ba-9dfb-0af985ae7ea6", "dosage_form": "TABLET", "pharm_class": ["Leukotriene Receptor Antagonist [EPC]", "Leukotriene Receptor Antagonists [MoA]"], "product_ndc": "33342-102", "generic_name": "Montelukast", "labeler_name": "Macleods Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Montelukast", "active_ingredients": [{"name": "MONTELUKAST SODIUM", "strength": "10 mg/1"}], "application_number": "ANDA203366", "marketing_category": "ANDA", "marketing_start_date": "20140911", "listing_expiration_date": "20261231"}