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United States · US · US:59572-102_8cba79e2-11fa-4eb9-87e7-827ca781fbf3

VIDAZA

In shortageOrange BookUNIISPLATC L01BC07

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

Identification

ManufacturerCelgene Corporation
CountryUS (United States)
ATC codeL01BC07
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5957210201
    1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTON (59572-102-01)

Annotations

UNII (FDA Substance ID)
M801H13NRU
AZACITIDINE
RxCUI 1251
Orange Book
N050794
AP
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Azacitidine Injection
Raw payload (JSON)
{
  "unii": {
    "unii": "M801H13NRU",
    "rxcui": "1251",
    "inchikey": "NMUSYJAQQFHJEW-KVTDHHQDSA-N",
    "display_name": "AZACITIDINE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS; SUBCUTANEOUS",
  "spl_meta": {
    "3495a71a-cc04-4776-851f-f185956f32af": {
      "match": "brand_token",
      "title": "VIDAZA (AZACITIDINE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [CELGENE CORPORATION]",
      "spl_version": "22",
      "published_date": "2024-01-30"
    }
  },
  "productid": "59572-102_8cba79e2-11fa-4eb9-87e7-827ca781fbf3",
  "productndc": "59572-102",
  "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
  "orange_book": {
    "appl_no": "050794",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "100MG/VIAL",
        "product_no": "001",
        "approval_date": "May 19, 2004"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "AZACITIDINE",
  "shortage_reason": "Azacitidine Injection",
  "shortage_status": "current",
  "proprietary_name": "VIDAZA",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA050794",
  "marketing_category": "NDA",
  "nonproprietary_name": "azacitidine",
  "start_marketing_date": "20040705",
  "active_numerator_strength": "100"
}

Related drugs

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