Cytarabine

Orange BookUNIISPLATC L01BC01

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerFresenius Kabi USA, LLC

CountryUS (United States)

ATC codeL01BC01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6332312020
1 VIAL, SINGLE-DOSE in 1 CARTON (63323-120-20) / 20 mL in 1 VIAL, SINGLE-DOSE

Annotations

UNII (FDA Substance ID)

04079A1RDZ

CYTARABINE

RxCUI 3041

Orange Book

A076512

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": "INTRATHECAL; 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": "63323-120_88adbc49-b19d-44af-8f0b-a563bbb02aec",
  "productndc": "63323-120",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "076512",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AP",
        "strength": "100MG/ML",
        "product_no": "001",
        "approval_date": "Jan 15, 2004"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CYTARABINE",
  "proprietary_name": "Cytarabine",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA076512",
  "marketing_category": "ANDA",
  "nonproprietary_name": "CYTARABINE",
  "start_marketing_date": "20041129",
  "active_numerator_strength": "100"
}

Related drugs

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