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United States · US · US:70121-1658_773ddbdb-5a14-4f97-8db8-9a874d129153

Arsenic Trioxide

In shortageOrange BookUNIISPLATC L01XX27

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

Identification

ManufacturerAmneal Pharmaceuticals LLC
CountryUS (United States)
ATC codeL01XX27
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7012116581
    10 VIAL, SINGLE-DOSE in 1 CARTON (70121-1658-1) / 6 mL in 1 VIAL, SINGLE-DOSE (70121-1658-6)

Annotations

UNII (FDA Substance ID)
S7V92P67HO
ARSENIC TRIOXIDE
RxCUI 18330
Orange Book
A210739
APAP
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": "70121-1658_773ddbdb-5a14-4f97-8db8-9a874d129153",
  "productndc": "70121-1658",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "210739",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "1MG/ML",
        "product_no": "001",
        "approval_date": "Jan 25, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "2MG/ML",
        "product_no": "002",
        "approval_date": "Aug 19, 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": "ANDA210739",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Arsenic Trioxide",
  "start_marketing_date": "20210820",
  "active_numerator_strength": "2"
}

Related drugs

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