VYXEOS
These highlights do not include all the information needed to use VYXEOS safely and effectively. See full prescribing information for VYXEOS. VYXEOS (daunorubicin and cytarabine) liposome for injection, for intravenous useInitial U.S. Approval: 2017
Approved
Approval ID
7ea701ce-e7d3-4349-a9c2-642a501d45c8
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 27, 2022
Manufacturers
FDA
Jazz Pharmaceuticals, Inc.
DUNS: 135926363
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
(daunorubicin and cytarabine) liposome
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68727-745
Application NumberNDA209401
Product Classification
M
Marketing Category
C73594
G
Generic Name
(daunorubicin and cytarabine) liposome
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateAugust 3, 2017
FDA Product Classification
INGREDIENTS (8)
DISTEAROYLPHOSPHATIDYLCHOLINE, DL-Inactive
Quantity: 454 mg in 20 mL
Code: EAG959U971
Classification: IACT
DISTEAROYLPHOSPHATIDYLGLYCEROL, DL-Inactive
Quantity: 132 mg in 20 mL
Code: 4271ZA8WXO
Classification: IACT
CHOLESTEROLInactive
Quantity: 32 mg in 20 mL
Code: 97C5T2UQ7J
Classification: IACT
COPPER GLUCONATEInactive
Quantity: 100 mg in 20 mL
Code: RV823G6G67
Classification: IACT
TROLAMINEInactive
Quantity: 4 mg in 20 mL
Code: 9O3K93S3TK
Classification: IACT
SUCROSEInactive
Quantity: 2054 mg in 20 mL
Code: C151H8M554
Classification: IACT
CYTARABINEActive
Quantity: 100 mg in 20 mL
Code: 04079A1RDZ
Classification: ACTIB
DAUNORUBICINActive
Quantity: 44 mg in 20 mL
Code: ZS7284E0ZP
Classification: ACTIB