zafirlukast

Generic: zafirlukast

Labeler: american health packaging
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name zafirlukast
Generic Name zafirlukast
Labeler american health packaging
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

zafirlukast 20 mg/1

Manufacturer
American Health Packaging

Identifiers & Regulatory

Product NDC 68084-059
Product ID 68084-059_2434193f-6ba4-923d-e063-6394a90aec0c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090372
Listing Expiration 2026-12-31
Marketing Start 2013-06-03

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 68084059
Hyphenated Format 68084-059

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 ANDA090372 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 30 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-059-21) / 1 TABLET, FILM COATED in 1 BLISTER PACK (68084-059-11)
source: ndc

Packages (1)

68084-059-21 30 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-059-21) / 1 TABLET, FILM COATED in 1 BLISTER PACK (68084-059-11)

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": "2434193f-6ba4-923d-e063-6394a90aec0c", "openfda": {"nui": ["N0000175777", "N0000000083", "N0000185504"], "unii": ["XZ629S5L50"], "rxcui": ["199655"], "spl_set_id": ["a60f39f6-d590-4b00-8751-7f12b7ec5385"], "pharm_class_epc": ["Leukotriene Receptor Antagonist [EPC]"], "pharm_class_moa": ["Leukotriene Receptor Antagonists [MoA]", "Cytochrome P450 2C9 Inhibitors [MoA]"], "manufacturer_name": ["American Health Packaging"]}, "finished": true, "packaging": [{"sample": false, "description": "30 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-059-21)  / 1 TABLET, FILM COATED in 1 BLISTER PACK (68084-059-11)", "package_ndc": "68084-059-21", "marketing_start_date": "20130603"}], "brand_name": "Zafirlukast", "product_id": "68084-059_2434193f-6ba4-923d-e063-6394a90aec0c", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Cytochrome P450 2C9 Inhibitors [MoA]", "Leukotriene Receptor Antagonist [EPC]", "Leukotriene Receptor Antagonists [MoA]"], "product_ndc": "68084-059", "generic_name": "Zafirlukast", "labeler_name": "American Health Packaging", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Zafirlukast", "active_ingredients": [{"name": "ZAFIRLUKAST", "strength": "20 mg/1"}], "application_number": "ANDA090372", "marketing_category": "ANDA", "marketing_start_date": "20130603", "listing_expiration_date": "20261231"}