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United States · US · US:43598-142_8105c460-afd8-5eec-7857-c2e4e5b89fc3

Nelarabine

Orange BookUNIISPLATC L01BB07

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

Identification

ManufacturerDr. Reddy's Laboratories, Inc.
CountryUS (United States)
ATC codeL01BB07
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    4359814206
    6 VIAL, SINGLE-DOSE in 1 CARTON (43598-142-06) / 50 mL in 1 VIAL, SINGLE-DOSE
  • ndc11
    4359814211
    1 VIAL, SINGLE-DOSE in 1 CARTON (43598-142-11) / 50 mL in 1 VIAL, SINGLE-DOSE

Annotations

UNII (FDA Substance ID)
60158CV180
NELARABINE
RxCUI 274771
Orange Book
A216934
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": "43598-142_8105c460-afd8-5eec-7857-c2e4e5b89fc3",
  "productndc": "43598-142",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "216934",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "250MG/50ML (5MG/ML)",
        "product_no": "001",
        "approval_date": "Dec 23, 2022"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "NELARABINE",
  "proprietary_name": "Nelarabine",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA216934",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Nelarabine",
  "start_marketing_date": "20230109",
  "active_numerator_strength": "5"
}

Related drugs

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