🇺🇸
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
- ndc11687277450120 mL in 1 VIAL (68727-745-01)
- ndc11687277450240 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"
}Related drugs
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