montelukast sodium

Generic: montelukast sodium

Labeler: unichem pharmaceuticals (usa), inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name montelukast sodium
Generic Name montelukast sodium
Labeler unichem pharmaceuticals (usa), inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

montelukast sodium 10 mg/1

Manufacturer
Unichem Pharmaceuticals (USA), Inc.

Identifiers & Regulatory

Product NDC 29300-220
Product ID 29300-220_57f07f65-1a14-4423-9da8-975664ca0684
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204290
Listing Expiration 2026-12-31
Marketing Start 2016-01-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 29300220
Hyphenated Format 29300-220

Supplemental Identifiers

RxCUI
200224 242438 311759
UPC
0329300221138 0329300222135
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 sodium (source: ndc)
Generic Name montelukast sodium (source: ndc)
Application Number ANDA204290 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-220-01)
  • 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-220-10)
  • 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-220-13)
  • 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-220-19)
source: ndc

Packages (4)

29300-220-01 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-220-01) 29300-220-10 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-220-10) 29300-220-13 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-220-13) 29300-220-19 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-220-19)

Ingredients (1)

montelukast sodium (10 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": "57f07f65-1a14-4423-9da8-975664ca0684", "openfda": {"upc": ["0329300221138", "0329300222135"], "unii": ["U1O3J18SFL"], "rxcui": ["200224", "242438", "311759"], "spl_set_id": ["9e375c07-70db-458c-9336-22a7037b0a5f"], "manufacturer_name": ["Unichem Pharmaceuticals (USA), Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-220-01)", "package_ndc": "29300-220-01", "marketing_start_date": "20160101"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-220-10)", "package_ndc": "29300-220-10", "marketing_start_date": "20160101"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-220-13)", "package_ndc": "29300-220-13", "marketing_start_date": "20160101"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-220-19)", "package_ndc": "29300-220-19", "marketing_start_date": "20160101"}], "brand_name": "montelukast sodium", "product_id": "29300-220_57f07f65-1a14-4423-9da8-975664ca0684", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Leukotriene Receptor Antagonist [EPC]", "Leukotriene Receptor Antagonists [MoA]"], "product_ndc": "29300-220", "generic_name": "montelukast sodium", "labeler_name": "Unichem Pharmaceuticals (USA), Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "montelukast sodium", "active_ingredients": [{"name": "MONTELUKAST SODIUM", "strength": "10 mg/1"}], "application_number": "ANDA204290", "marketing_category": "ANDA", "marketing_start_date": "20160101", "listing_expiration_date": "20261231"}