zafirlukast

Generic: zafirlukast

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name zafirlukast
Generic Name zafirlukast
Labeler aurobindo pharma limited
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

zafirlukast 20 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 59651-292
Product ID 59651-292_8bdb47c5-9d19-4d59-94c8-62c117525e7f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213163
Listing Expiration 2026-12-31
Marketing Start 2023-11-27

Pharmacologic Class

Established (EPC)
leukotriene receptor antagonist [epc]
Mechanism of Action
leukotriene receptor antagonists [moa] cytochrome p450 2c9 inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 59651292
Hyphenated Format 59651-292

Supplemental Identifiers

RxCUI
199655 313758
UPC
0359651291603 0359651292600
UNII
XZ629S5L50
NUI
N0000175777 N0000000083 N0000185504

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 zafirlukast (source: ndc)
Generic Name zafirlukast (source: ndc)
Application Number ANDA213163 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 60 TABLET, FILM COATED in 1 BOTTLE (59651-292-60)
source: ndc

Packages (1)

59651-292-60 60 TABLET, FILM COATED in 1 BOTTLE (59651-292-60)

Ingredients (1)

zafirlukast (20 mg/1)

Linked Drug Pages (1)

Zafirlukast ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "8bdb47c5-9d19-4d59-94c8-62c117525e7f", "openfda": {"nui": ["N0000175777", "N0000000083", "N0000185504"], "upc": ["0359651291603", "0359651292600"], "unii": ["XZ629S5L50"], "rxcui": ["199655", "313758"], "spl_set_id": ["8bdb47c5-9d19-4d59-94c8-62c117525e7f"], "pharm_class_epc": ["Leukotriene Receptor Antagonist [EPC]"], "pharm_class_moa": ["Leukotriene Receptor Antagonists [MoA]", "Cytochrome P450 2C9 Inhibitors [MoA]"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (59651-292-60)", "package_ndc": "59651-292-60", "marketing_start_date": "20231127"}], "brand_name": "Zafirlukast", "product_id": "59651-292_8bdb47c5-9d19-4d59-94c8-62c117525e7f", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Cytochrome P450 2C9 Inhibitors [MoA]", "Leukotriene Receptor Antagonist [EPC]", "Leukotriene Receptor Antagonists [MoA]"], "product_ndc": "59651-292", "generic_name": "Zafirlukast", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Zafirlukast", "active_ingredients": [{"name": "ZAFIRLUKAST", "strength": "20 mg/1"}], "application_number": "ANDA213163", "marketing_category": "ANDA", "marketing_start_date": "20231127", "listing_expiration_date": "20261231"}