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United States · US · US:0781-3498_601a01b0-da7f-4b9d-9f66-bc67371a1268

Arsenic Trioxide

In shortageOrange BookUNIISPLATC L01XX27

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerSandoz Inc
CountryUS (United States)
ATC codeL01XX27
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    0781349894
    1 VIAL in 1 CARTON (0781-3498-94) / 6 mL in 1 VIAL
  • ndc11
    0781349895
    10 VIAL in 1 CARTON (0781-3498-95) / 6 mL in 1 VIAL (0781-3498-06)

Annotations

UNII (FDA Substance ID)
S7V92P67HO
ARSENIC TRIOXIDE
RxCUI 18330
Orange Book
A215359
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": {
    "c99b01b4-67ff-4793-8375-fe3a21c6c9be": {
      "match": "brand_token",
      "title": "ARSENIC TRIOXIDE INJECTION [INGENUS PHARMACEUTICALS, LLC]",
      "spl_version": "11",
      "published_date": "2025-12-11"
    }
  },
  "productid": "0781-3498_601a01b0-da7f-4b9d-9f66-bc67371a1268",
  "productndc": "0781-3498",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "215359",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "2MG/ML",
        "product_no": "001",
        "approval_date": "Dec 2, 2021"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ARSENIC TRIOXIDE",
  "shortage_reason": "Arsenic Trioxide Injection",
  "shortage_status": "current",
  "proprietary_name": "Arsenic Trioxide",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA215359",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Arsenic Trioxide",
  "start_marketing_date": "20220519",
  "active_numerator_strength": "2"
}

Related drugs

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