zafirlukast

Generic: zafirlukast

Labeler: avkare
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name zafirlukast
Generic Name zafirlukast
Labeler avkare
Dosage Form TABLET, COATED
Routes
ORAL
Active Ingredients

zafirlukast 20 mg/1

Manufacturer
AvKARE

Identifiers & Regulatory

Product NDC 42291-971
Product ID 42291-971_3b3c7fd6-2d93-6df8-e063-6294a90a841f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA020547
Listing Expiration 2026-12-31
Marketing Start 2023-04-05

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 42291971
Hyphenated Format 42291-971

Supplemental Identifiers

RxCUI
199655 313758
UNII
XZ629S5L50
NUI
N0000175777 N0000000083 N0000185504

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 NDA020547 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 60 TABLET, COATED in 1 BOTTLE (42291-971-60)
source: ndc

Packages (1)

42291-971-60 60 TABLET, COATED in 1 BOTTLE (42291-971-60)

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": "3b3c7fd6-2d93-6df8-e063-6294a90a841f", "openfda": {"nui": ["N0000175777", "N0000000083", "N0000185504"], "unii": ["XZ629S5L50"], "rxcui": ["199655", "313758"], "spl_set_id": ["f89a821d-396f-a3aa-e053-6294a90a4577"], "pharm_class_epc": ["Leukotriene Receptor Antagonist [EPC]"], "pharm_class_moa": ["Leukotriene Receptor Antagonists [MoA]", "Cytochrome P450 2C9 Inhibitors [MoA]"], "manufacturer_name": ["AvKARE"]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET, COATED in 1 BOTTLE (42291-971-60)", "package_ndc": "42291-971-60", "marketing_start_date": "20230405"}], "brand_name": "Zafirlukast", "product_id": "42291-971_3b3c7fd6-2d93-6df8-e063-6294a90a841f", "dosage_form": "TABLET, COATED", "pharm_class": ["Cytochrome P450 2C9 Inhibitors [MoA]", "Leukotriene Receptor Antagonist [EPC]", "Leukotriene Receptor Antagonists [MoA]"], "product_ndc": "42291-971", "generic_name": "zafirlukast", "labeler_name": "AvKARE", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Zafirlukast", "active_ingredients": [{"name": "ZAFIRLUKAST", "strength": "20 mg/1"}], "application_number": "NDA020547", "marketing_category": "NDA", "marketing_start_date": "20230405", "listing_expiration_date": "20261231"}