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United States · US · US:70771-1685_d96809f2-f942-4f6d-92b9-0a23ec84226d

Nelarabine

Orange BookUNIISPLATC L01BB07

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

Identification

ManufacturerZydus Lifesciences Limited
CountryUS (United States)
ATC codeL01BB07
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    7077116851
    1 VIAL in 1 CARTON (70771-1685-1) / 50 mL in 1 VIAL
  • ndc11
    7077116858
    6 VIAL in 1 CARTON (70771-1685-8) / 50 mL in 1 VIAL

Annotations

UNII (FDA Substance ID)
60158CV180
NELARABINE
RxCUI 274771
Orange Book
A215037
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": "70771-1685_d96809f2-f942-4f6d-92b9-0a23ec84226d",
  "productndc": "70771-1685",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "215037",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "250MG/50ML (5MG/ML)",
        "product_no": "001",
        "approval_date": "Nov 17, 2021"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "NELARABINE",
  "proprietary_name": "Nelarabine",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA215037",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Nelarabine",
  "start_marketing_date": "20211117",
  "active_numerator_strength": "5"
}

Related drugs

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