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United States · US · US:70121-1743_0aa120d1-67cb-4be7-8884-d716d8b2b8ab

Nelarabine

Orange BookUNIISPLATC L01BB07

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

Identification

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

Packs · 2

  • ndc11
    7012117431
    1 VIAL, SINGLE-DOSE in 1 CARTON (70121-1743-1) / 50 mL in 1 VIAL, SINGLE-DOSE
  • ndc11
    7012117434
    6 VIAL, SINGLE-DOSE in 1 CARTON (70121-1743-4) / 50 mL in 1 VIAL, SINGLE-DOSE

Annotations

UNII (FDA Substance ID)
60158CV180
NELARABINE
RxCUI 274771
Orange Book
A216346
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": {
    "8d0e1b59-bd1e-4c6e-9a95-e8143ee076bf": {
      "match": "brand_token",
      "title": "NELARABINE INJECTION [AMNEAL PHARMACEUTICALS LLC]",
      "spl_version": "8",
      "published_date": "2026-03-31"
    }
  },
  "productid": "70121-1743_0aa120d1-67cb-4be7-8884-d716d8b2b8ab",
  "productndc": "70121-1743",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "216346",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "250MG/50ML (5MG/ML)",
        "product_no": "001",
        "approval_date": "Apr 4, 2023"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "NELARABINE",
  "proprietary_name": "Nelarabine",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA216346",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Nelarabine",
  "start_marketing_date": "20230410",
  "active_numerator_strength": "5"
}

Related drugs

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