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United States · US · US:51407-741_f7573809-771b-04c9-e053-6294a90ab193
Zileuton
Orange BookUNIISPL
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerGolden State Medical Supply, Inc.
CountryUS (United States)
ATC code—
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc115140774112120 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE (51407-741-12)
Annotations
UNII (FDA Substance ID)
V1L22WVE2S
ZILEUTON
RxCUI 40575
Orange Book
A212670
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": "51407-741_f7573809-771b-04c9-e053-6294a90ab193",
"productndc": "51407-741",
"dosage_form": "TABLET, MULTILAYER, EXTENDED RELEASE",
"orange_book": {
"appl_no": "212670",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "600MG",
"product_no": "001",
"approval_date": "Dec 16, 2019"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ZILEUTON",
"proprietary_name": "Zileuton",
"active_ingred_unit": "mg/1",
"application_number": "ANDA212670",
"marketing_category": "ANDA",
"nonproprietary_name": "zileuton",
"start_marketing_date": "20191216",
"active_numerator_strength": "600"
}Access this data programmatically
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