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United States · US · US:71288-168_038a9b4b-a951-4c8c-be74-00a4a64eedd1

Cytarabine

Orange BookUNIISPLATC L01BC01

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

Identification

ManufacturerMeitheal Pharmaceuticals Inc.
CountryUS (United States)
ATC codeL01BC01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7128816850
    1 VIAL, MULTI-DOSE in 1 CARTON (71288-168-50) / 50 mL in 1 VIAL, MULTI-DOSE

Annotations

UNII (FDA Substance ID)
04079A1RDZ
CYTARABINE
RxCUI 3041
Orange Book
A206190
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "04079A1RDZ",
    "rxcui": "3041",
    "inchikey": "UHDGCWIWMRVCDJ-CCXZUQQUSA-N",
    "display_name": "CYTARABINE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS; SUBCUTANEOUS",
  "spl_meta": {
    "277597b0-7d85-40a3-a34a-70c6a883fc6d": {
      "match": "brand_token",
      "title": "CYTARABINE INJECTION, SOLUTION [HOSPIRA, INC.]",
      "spl_version": "13",
      "published_date": "2025-09-01"
    }
  },
  "productid": "71288-168_038a9b4b-a951-4c8c-be74-00a4a64eedd1",
  "productndc": "71288-168",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "206190",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "20MG/ML",
        "product_no": "001",
        "approval_date": "Nov 9, 2017"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CYTARABINE",
  "proprietary_name": "Cytarabine",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA206190",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Cytarabine",
  "start_marketing_date": "20171109",
  "active_numerator_strength": "20"
}

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