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, CHEWABLE
Routes
ORAL
Active Ingredients

montelukast 5 mg/1

Manufacturer
Preferred Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 68788-7669
Product ID 68788-7669_f9ab7e9f-ce5e-4c52-919e-66602d0c719e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204093
Listing Expiration 2027-12-31
Marketing Start 2020-02-28

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 687887669
Hyphenated Format 68788-7669

Supplemental Identifiers

RxCUI
242438
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
  • 5 mg/1
source: ndc
Packaging
  • 10 TABLET, CHEWABLE in 1 BOTTLE (68788-7669-1)
  • 20 TABLET, CHEWABLE in 1 BOTTLE (68788-7669-2)
  • 30 TABLET, CHEWABLE in 1 BOTTLE (68788-7669-3)
  • 14 TABLET, CHEWABLE in 1 BOTTLE (68788-7669-4)
  • 60 TABLET, CHEWABLE in 1 BOTTLE (68788-7669-6)
  • 90 TABLET, CHEWABLE in 1 BOTTLE (68788-7669-9)
source: ndc

Packages (6)

68788-7669-1 10 TABLET, CHEWABLE in 1 BOTTLE (68788-7669-1) 68788-7669-2 20 TABLET, CHEWABLE in 1 BOTTLE (68788-7669-2) 68788-7669-3 30 TABLET, CHEWABLE in 1 BOTTLE (68788-7669-3) 68788-7669-4 14 TABLET, CHEWABLE in 1 BOTTLE (68788-7669-4) 68788-7669-6 60 TABLET, CHEWABLE in 1 BOTTLE (68788-7669-6) 68788-7669-9 90 TABLET, CHEWABLE in 1 BOTTLE (68788-7669-9)

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": "f9ab7e9f-ce5e-4c52-919e-66602d0c719e", "openfda": {"nui": ["N0000175777", "N0000000083"], "unii": ["MHM278SD3E"], "rxcui": ["242438"], "spl_set_id": ["09b0bc9e-3035-45b4-b61b-4aca70848360"], "pharm_class_epc": ["Leukotriene Receptor Antagonist [EPC]"], "pharm_class_moa": ["Leukotriene Receptor Antagonists [MoA]"], "manufacturer_name": ["Preferred Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "10 TABLET, CHEWABLE in 1 BOTTLE (68788-7669-1)", "package_ndc": "68788-7669-1", "marketing_start_date": "20200228"}, {"sample": false, "description": "20 TABLET, CHEWABLE in 1 BOTTLE (68788-7669-2)", "package_ndc": "68788-7669-2", "marketing_start_date": "20200228"}, {"sample": false, "description": "30 TABLET, CHEWABLE in 1 BOTTLE (68788-7669-3)", "package_ndc": "68788-7669-3", "marketing_start_date": "20200228"}, {"sample": false, "description": "14 TABLET, CHEWABLE in 1 BOTTLE (68788-7669-4)", "package_ndc": "68788-7669-4", "marketing_start_date": "20200228"}, {"sample": false, "description": "60 TABLET, CHEWABLE in 1 BOTTLE (68788-7669-6)", "package_ndc": "68788-7669-6", "marketing_start_date": "20200228"}, {"sample": false, "description": "90 TABLET, CHEWABLE in 1 BOTTLE (68788-7669-9)", "package_ndc": "68788-7669-9", "marketing_start_date": "20200228"}], "brand_name": "montelukast sodium", "product_id": "68788-7669_f9ab7e9f-ce5e-4c52-919e-66602d0c719e", "dosage_form": "TABLET, CHEWABLE", "pharm_class": ["Leukotriene Receptor Antagonist [EPC]", "Leukotriene Receptor Antagonists [MoA]"], "product_ndc": "68788-7669", "generic_name": "montelukast sodium", "labeler_name": "Preferred Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "montelukast sodium", "active_ingredients": [{"name": "MONTELUKAST", "strength": "5 mg/1"}], "application_number": "ANDA204093", "marketing_category": "ANDA", "marketing_start_date": "20200228", "listing_expiration_date": "20271231"}