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United States · US · US:0078-0683_b1a3f864-56e1-44da-b2d0-7158d0945513

Arranon

Orange BookUNIISPLATC L01BB07

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

Identification

ManufacturerNovartis Pharmaceuticals Corporation
CountryUS (United States)
ATC codeL01BB07
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0078068361
    50 mL in 1 VIAL (0078-0683-61)

Annotations

UNII (FDA Substance ID)
60158CV180
NELARABINE
RxCUI 274771
Orange Book
N021877
AP
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "60158CV180",
    "rxcui": "274771",
    "inchikey": "IXOXBSCIXZEQEQ-UHTZMRCNSA-N",
    "display_name": "NELARABINE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "0f9051de-5c4d-4c0f-8c19-e15214498cca": {
      "match": "brand_token",
      "title": "ARRANON (NELARABINE) INJECTION [SANDOZ INC]",
      "spl_version": "4",
      "published_date": "2026-03-23"
    }
  },
  "productid": "0078-0683_b1a3f864-56e1-44da-b2d0-7158d0945513",
  "productndc": "0078-0683",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "021877",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "250MG/50ML (5MG/ML)",
        "product_no": "001",
        "approval_date": "Oct 28, 2005"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "NELARABINE",
  "proprietary_name": "Arranon",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA021877",
  "marketing_category": "NDA",
  "nonproprietary_name": "nelarabine",
  "start_marketing_date": "20161005",
  "active_numerator_strength": "5"
}

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