montelukast sodium

Generic: montelukast sodium

Labeler: preferred pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name montelukast sodium
Generic Name montelukast sodium
Labeler preferred pharmaceuticals inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

montelukast sodium 10 mg/1

Manufacturer
Preferred Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 68788-8617
Product ID 68788-8617_68ee9209-7a6b-4f51-9252-2e22baaa58f4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204290
Listing Expiration 2026-12-31
Marketing Start 2024-03-28

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 687888617
Hyphenated Format 68788-8617

Supplemental Identifiers

RxCUI
200224
UNII
U1O3J18SFL

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
  • 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-8617-3)
  • 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-8617-6)
  • 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-8617-9)
source: ndc

Packages (3)

68788-8617-3 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-8617-3) 68788-8617-6 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-8617-6) 68788-8617-9 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-8617-9)

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": "68ee9209-7a6b-4f51-9252-2e22baaa58f4", "openfda": {"unii": ["U1O3J18SFL"], "rxcui": ["200224"], "spl_set_id": ["1eeb3123-9e93-4681-8096-800a7c7acf8a"], "manufacturer_name": ["Preferred Pharmaceuticals Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-8617-3)", "package_ndc": "68788-8617-3", "marketing_start_date": "20240328"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-8617-6)", "package_ndc": "68788-8617-6", "marketing_start_date": "20240328"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-8617-9)", "package_ndc": "68788-8617-9", "marketing_start_date": "20240328"}], "brand_name": "montelukast sodium", "product_id": "68788-8617_68ee9209-7a6b-4f51-9252-2e22baaa58f4", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Leukotriene Receptor Antagonist [EPC]", "Leukotriene Receptor Antagonists [MoA]"], "product_ndc": "68788-8617", "generic_name": "montelukast sodium", "labeler_name": "Preferred Pharmaceuticals 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": "20240328", "listing_expiration_date": "20261231"}