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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

  • ndc11
    6345960106
    10 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        "strength": "1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",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

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