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United States · US · US:72205-154_d556a9e7-310b-41dc-99f8-a281fe7da3fe

NELARABINE

Orange BookUNIISPLATC L01BB07

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

Identification

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

Packs · 2

  • ndc11
    7220515401
    1 VIAL in 1 CARTON (72205-154-01) / 50 mL in 1 VIAL
  • ndc11
    7220515404
    6 VIAL in 1 CARTON (72205-154-04) / 50 mL in 1 VIAL

Annotations

UNII (FDA Substance ID)
60158CV180
NELARABINE
RxCUI 274771
Orange Book
A216948
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": "72205-154_d556a9e7-310b-41dc-99f8-a281fe7da3fe",
  "productndc": "72205-154",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "216948",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "250MG/50ML (5MG/ML)",
        "product_no": "001",
        "approval_date": "Sep 13, 2024"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "NELARABINE",
  "proprietary_name": "NELARABINE",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA216948",
  "marketing_category": "ANDA",
  "nonproprietary_name": "NELARABINE",
  "start_marketing_date": "20240913",
  "active_numerator_strength": "5"
}

Related drugs

Other records sharing ATC code L01BB07.

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