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United States · US · US:10122-901_d49e40c7-0635-4220-8b0a-c5068116ee17
ZYFLO
Orange BookUNIISPL
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerChiesi USA, Inc.
CountryUS (United States)
ATC code—
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc111012290112120 TABLET in 1 BOTTLE (10122-901-12)
Annotations
UNII (FDA Substance ID)
V1L22WVE2S
ZILEUTON
RxCUI 40575
Orange Book
N020471
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "V1L22WVE2S",
"rxcui": "40575",
"inchikey": "MWLSOWXNZPKENC-UHFFFAOYSA-N",
"display_name": "ZILEUTON",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"aee65202-fddb-497f-9f11-17cc727cb157": {
"match": "brand_token",
"title": "ZYFLO (ZILEUTON) TABLET [CHIESI USA, INC.]",
"spl_version": "33",
"published_date": "2025-11-18"
}
},
"productid": "10122-901_d49e40c7-0635-4220-8b0a-c5068116ee17",
"productndc": "10122-901",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "020471",
"products": [
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "300MG",
"product_no": "001",
"approval_date": "Dec 9, 1996"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "600MG",
"product_no": "003",
"approval_date": "Dec 9, 1996"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ZILEUTON",
"proprietary_name": "ZYFLO",
"active_ingred_unit": "mg/1",
"application_number": "NDA020471",
"marketing_category": "NDA",
"nonproprietary_name": "zileuton",
"start_marketing_date": "19961206",
"active_numerator_strength": "600"
}Access this data programmatically
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