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United States · US · US:72603-246_17766300-70b8-ee56-e063-6294a90aeb1a
Zileuton
Orange BookUNIISPL
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerNorthStar RxLLC
CountryUS (United States)
ATC code—
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc117260324601120 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (72603-246-01)
Annotations
UNII (FDA Substance ID)
V1L22WVE2S
ZILEUTON
RxCUI 40575
Orange Book
A215742
AB
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": {
"fd382540-b390-4e86-a94a-988ea89c93a8": {
"match": "brand_token",
"title": "ZILEUTON TABLET, EXTENDED RELEASE [RISING PHARMA HOLDINGS, INC.]",
"spl_version": "7",
"published_date": "2024-05-24"
}
},
"productid": "72603-246_17766300-70b8-ee56-e063-6294a90aeb1a",
"productndc": "72603-246",
"dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE",
"orange_book": {
"appl_no": "215742",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "600MG",
"product_no": "001",
"approval_date": "Oct 11, 2022"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ZILEUTON",
"proprietary_name": "Zileuton",
"active_ingred_unit": "mg/1",
"application_number": "ANDA215742",
"marketing_category": "ANDA",
"nonproprietary_name": "Zileuton",
"start_marketing_date": "20240501",
"active_numerator_strength": "600"
}Access this data programmatically
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