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United States · US · US:31722-044_eaf892a4-41c4-70e0-e053-2995a90a2079
Zileuton
Orange BookUNIISPL
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerCamber Pharmaceuticals, Inc.
CountryUS (United States)
ATC code—
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc113172204412120 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (31722-044-12)
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": "31722-044_eaf892a4-41c4-70e0-e053-2995a90a2079",
"productndc": "31722-044",
"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": "20221011",
"active_numerator_strength": "600"
}Access this data programmatically
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