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United States · US · US:61703-319_2af445e4-993f-4fec-a276-c01ff2451e92

Cytarabine

Orange BookUNIISPLATC L01BC01

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

Identification

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

Packs · 1

  • ndc11
    6170331922
    1 VIAL, SINGLE-DOSE in 1 CARTON (61703-319-22) / 20 mL in 1 VIAL, SINGLE-DOSE

Annotations

UNII (FDA Substance ID)
04079A1RDZ
CYTARABINE
RxCUI 3041
Orange Book
A075383
AP
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": "61703-319_2af445e4-993f-4fec-a276-c01ff2451e92",
  "productndc": "61703-319",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "075383",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "100MG/ML",
        "product_no": "001",
        "approval_date": "Nov 22, 1999"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CYTARABINE",
  "proprietary_name": "Cytarabine",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA075383",
  "marketing_category": "ANDA",
  "nonproprietary_name": "CYTARABINE",
  "start_marketing_date": "19991122",
  "active_numerator_strength": "100"
}

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