zyflo

Generic: zileuton

Labeler: chiesi usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name zyflo
Generic Name zileuton
Labeler chiesi usa, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

zileuton 600 mg/1

Manufacturer
Chiesi USA, Inc.

Identifiers & Regulatory

Product NDC 10122-901
Product ID 10122-901_d49e40c7-0635-4220-8b0a-c5068116ee17
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA020471
Marketing Start 1996-12-06
Marketing End 2027-11-30

Pharmacologic Class

Established (EPC)
5-lipoxygenase inhibitor [epc]
Mechanism of Action
5-lipoxygenase inhibitors [moa]
Physiologic Effect
decreased leukotriene production [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 10122901
Hyphenated Format 10122-901

Supplemental Identifiers

RxCUI
199904 211777
UNII
V1L22WVE2S
NUI
N0000175956 N0000175955 N0000008683

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 zyflo (source: ndc)
Generic Name zileuton (source: ndc)
Application Number NDA020471 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 600 mg/1
source: ndc
Packaging
  • 120 TABLET in 1 BOTTLE (10122-901-12)
source: ndc

Packages (1)

10122-901-12 120 TABLET in 1 BOTTLE (10122-901-12)

Ingredients (1)

zileuton (600 mg/1)

Linked Drug Pages (1)

ZYFLO ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "d49e40c7-0635-4220-8b0a-c5068116ee17", "openfda": {"nui": ["N0000175956", "N0000175955", "N0000008683"], "unii": ["V1L22WVE2S"], "rxcui": ["199904", "211777"], "spl_set_id": ["aee65202-fddb-497f-9f11-17cc727cb157"], "pharm_class_pe": ["Decreased Leukotriene Production [PE]"], "pharm_class_epc": ["5-Lipoxygenase Inhibitor [EPC]"], "pharm_class_moa": ["5-Lipoxygenase Inhibitors [MoA]"], "manufacturer_name": ["Chiesi USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "120 TABLET in 1 BOTTLE (10122-901-12)", "package_ndc": "10122-901-12", "marketing_end_date": "20271130", "marketing_start_date": "19961206"}], "brand_name": "ZYFLO", "product_id": "10122-901_d49e40c7-0635-4220-8b0a-c5068116ee17", "dosage_form": "TABLET", "pharm_class": ["5-Lipoxygenase Inhibitor [EPC]", "5-Lipoxygenase Inhibitors [MoA]", "Decreased Leukotriene Production [PE]"], "product_ndc": "10122-901", "generic_name": "zileuton", "labeler_name": "Chiesi USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ZYFLO", "active_ingredients": [{"name": "ZILEUTON", "strength": "600 mg/1"}], "application_number": "NDA020471", "marketing_category": "NDA", "marketing_end_date": "20271130", "marketing_start_date": "19961206"}