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United States · US · US:68727-745_25abb1d8-f921-4aae-8240-1914cd80417a

VYXEOS

Orange BookUNIISPLATC L01BC

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

Identification

ManufacturerJazz Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeL01BC
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    6872774501
    20 mL in 1 VIAL (68727-745-01)
  • ndc11
    6872774502
    40 mL in 1 CARTON (68727-745-02)

Annotations

UNII (FDA Substance ID)
04079A1RDZ
CYTARABINE
RxCUI 3041
Orange Book
N209401
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",
  "spl_meta": {
    "7ea701ce-e7d3-4349-a9c2-642a501d45c8": {
      "match": "brand_token",
      "title": "VYXEOS ((DAUNORUBICIN AND CYTARABINE) LIPOSOME) INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION [JAZZ PHARMACEUTICALS, INC.]",
      "spl_version": "14",
      "published_date": "2026-02-09"
    }
  },
  "productid": "68727-745_25abb1d8-f921-4aae-8240-1914cd80417a",
  "productndc": "68727-745",
  "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION",
  "orange_book": {
    "appl_no": "209401",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "100MG;44MG",
        "product_no": "001",
        "approval_date": "Aug 3, 2017"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CYTARABINE; DAUNORUBICIN",
  "proprietary_name": "VYXEOS",
  "active_ingred_unit": "mg/20mL; mg/20mL",
  "application_number": "NDA209401",
  "marketing_category": "NDA",
  "nonproprietary_name": "(daunorubicin and cytarabine) liposome",
  "start_marketing_date": "20170803",
  "active_numerator_strength": "100; 44"
}

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