ONUREG

In shortageOrange BookUNIISPLATC L01BC07

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerCelgene Corporation

CountryUS (United States)

ATC codeL01BC07

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
5957274007
7 TABLET, FILM COATED in 1 BLISTER PACK (59572-740-07)
ndc11
5957274014
14 TABLET, FILM COATED in 1 BOTTLE (59572-740-14)

Annotations

UNII (FDA Substance ID)

M801H13NRU

AZACITIDINE

RxCUI 1251

Orange Book

N214120

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": "ORAL",
  "spl_meta": {
    "0e95e33f-8aba-4f19-b332-2416580d358b": {
      "match": "brand_token",
      "title": "ONUREG (AZACITIDINE) TABLET, FILM COATED [CELGENE CORPORATION]",
      "spl_version": "13",
      "published_date": "2026-04-17"
    }
  },
  "productid": "59572-740_6981b224-73db-4a2a-b901-ed7e5bffd5ea",
  "productndc": "59572-740",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "214120",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "200MG",
        "product_no": "001",
        "approval_date": "Sep 1, 2020"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "300MG",
        "product_no": "002",
        "approval_date": "Sep 1, 2020"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "AZACITIDINE",
  "shortage_reason": "Azacitidine Injection",
  "shortage_status": "current",
  "proprietary_name": "ONUREG",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA214120",
  "marketing_category": "NDA",
  "nonproprietary_name": "azacitidine",
  "start_marketing_date": "20200901",
  "active_numerator_strength": "300"
}

Related drugs

Other records sharing ATC code L01BC07.

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