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United States · US · US:49315-005_a8f76ffc-24cf-4d5b-9bd2-1ace0c66eec5

Arsenic trioxide

In shortageOrange BookUNIISPLATC L01XX27

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

Identification

ManufacturerZydus Lifesciences Limited
CountryUS (United States)
ATC codeL01XX27
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    4931500510
    10 VIAL in 1 CARTON (49315-005-10) / 10 mL in 1 VIAL (49315-005-01)

Annotations

UNII (FDA Substance ID)
S7V92P67HO
ARSENIC TRIOXIDE
RxCUI 18330
Orange Book
A206228
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": "49315-005_a8f76ffc-24cf-4d5b-9bd2-1ace0c66eec5",
  "productndc": "49315-005",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "206228",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "1MG/ML",
        "product_no": "001",
        "approval_date": "Nov 13, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "2MG/ML",
        "product_no": "002",
        "approval_date": "Aug 30, 2019"
      }
    ],
    "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": "ANDA206228",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Arsenic trioxide",
  "start_marketing_date": "20181114",
  "active_numerator_strength": "1"
}

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