🇺🇸
United States · US · US:63459-601_438426ea-1729-4b61-ad21-b979924204fe
Trisenox
In shortageOrange BookUNIISPLATC L01XX27
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerCephalon, LLC
CountryUS (United States)
ATC codeL01XX27
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11634596010610 VIAL, SINGLE-DOSE in 1 CARTON (63459-601-06) / 6 mL in 1 VIAL, SINGLE-DOSE (63459-601-11)
Annotations
UNII (FDA Substance ID)
S7V92P67HO
ARSENIC TRIOXIDE
RxCUI 18330
Orange Book
N021248
AP
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Arsenic Trioxide Injection
Raw payload (JSON)
{
"unii": {
"unii": "S7V92P67HO",
"rxcui": "18330",
"inchikey": "IKWTVSLWAPBBKU-UHFFFAOYSA-N",
"display_name": "ARSENIC TRIOXIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRAVENOUS",
"spl_meta": {
"101fc347-d0ad-4aee-8b06-9feb187fd741": {
"match": "brand_token",
"title": "TRISENOX (ARSENIC TRIOXIDE) INJECTION, SOLUTION [CEPHALON, LLC]",
"spl_version": "20",
"published_date": "2025-11-18"
}
},
"productid": "63459-601_438426ea-1729-4b61-ad21-b979924204fe",
"productndc": "63459-601",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "021248",
"products": [
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
"product_no": "001",
"approval_date": "Sep 25, 2000"
},
{
"rs": true,
"rld": true,
"te_code": "AP",
"strength": "2MG/ML",
"product_no": "002",
"approval_date": "Oct 13, 2017"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ARSENIC TRIOXIDE",
"shortage_reason": "Arsenic Trioxide Injection",
"shortage_status": "current",
"proprietary_name": "Trisenox",
"active_ingred_unit": "mg/mL",
"application_number": "NDA021248",
"marketing_category": "NDA",
"nonproprietary_name": "Arsenic Trioxide",
"start_marketing_date": "20171222",
"active_numerator_strength": "2"
}Related drugs
Other records sharing ATC code L01XX27.
- 🇺🇸Ars AlbEnergique, Inc.
- NLArseentrioxide CF 1 mg/ml, concentraat voor oplossing voor infusieCentrafarm B.V.
- 🇺🇸ARSENIC ALBRxhomeo Private Limited d.b.a. Rxhomeo, Inc
- 🇺🇸Arsenic trioxideZydus Pharmaceuticals USA Inc.
- 🇺🇸Arsenic trioxideZydus Lifesciences Limited
- 🇺🇸Arsenic trioxideZydus Pharmaceuticals USA Inc.
- 🇺🇸Arsenic trioxideZydus Pharmaceuticals USA Inc.
- 🇺🇸Arsenic trioxideZydus Pharmaceuticals USA Inc.
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