zafirlukast

Generic: zafirlukast

Labeler: bryant ranch prepack
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name zafirlukast
Generic Name zafirlukast
Labeler bryant ranch prepack
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

zafirlukast 20 mg/1

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 72162-2361
Product ID 72162-2361_50679c31-2161-47a0-a704-13a01760fdbf
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212475
Listing Expiration 2026-12-31
Marketing Start 2020-09-10

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 721622361
Hyphenated Format 72162-2361

Supplemental Identifiers

RxCUI
199655
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 ANDA212475 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 60 TABLET, FILM COATED in 1 BOTTLE (72162-2361-6)
source: ndc

Packages (1)

72162-2361-6 60 TABLET, FILM COATED in 1 BOTTLE (72162-2361-6)

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": "50679c31-2161-47a0-a704-13a01760fdbf", "openfda": {"nui": ["N0000175777", "N0000000083", "N0000185504"], "unii": ["XZ629S5L50"], "rxcui": ["199655"], "spl_set_id": ["d2256673-fe8b-4fba-a73a-a81e24e47cf8"], "pharm_class_epc": ["Leukotriene Receptor Antagonist [EPC]"], "pharm_class_moa": ["Leukotriene Receptor Antagonists [MoA]", "Cytochrome P450 2C9 Inhibitors [MoA]"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (72162-2361-6)", "package_ndc": "72162-2361-6", "marketing_start_date": "20240628"}], "brand_name": "Zafirlukast", "product_id": "72162-2361_50679c31-2161-47a0-a704-13a01760fdbf", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Cytochrome P450 2C9 Inhibitors [MoA]", "Leukotriene Receptor Antagonist [EPC]", "Leukotriene Receptor Antagonists [MoA]"], "product_ndc": "72162-2361", "generic_name": "Zafirlukast", "labeler_name": "Bryant Ranch Prepack", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Zafirlukast", "active_ingredients": [{"name": "ZAFIRLUKAST", "strength": "20 mg/1"}], "application_number": "ANDA212475", "marketing_category": "ANDA", "marketing_start_date": "20200910", "listing_expiration_date": "20261231"}