NDC 68727-745

VYXEOS

(daunorubicin And Cytarabine) Liposome

VYXEOS is a Intravenous Injection, Powder, Lyophilized, For Suspension in the Human Prescription Drug category. It is labeled and distributed by Jazz Pharmaceuticals, Inc.. The primary component is Cytarabine; Daunorubicin.

• Product ID: 68727-745_28c59550-ef14-423e-8cb2-cf4a38339cab
• NDC: 68727-745
• Product Type: Human Prescription Drug
• Proprietary Name: VYXEOS
• Generic Name: (daunorubicin And Cytarabine) Liposome
• Dosage Form: Injection, Powder, Lyophilized, For Suspension
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2017-08-03
• Marketing Category: NDA / NDA
• Application Number: NDA209401
• Labeler Name: Jazz Pharmaceuticals, Inc.
• Substance Name: CYTARABINE; DAUNORUBICIN
• Active Ingredient Strength: 100 mg/20mL; mg/20mL
• Pharm Classes: Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC],Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [CS],Topoisomerase Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 68727-745-01

20 mL in 1 VIAL (68727-745-01)

• Marketing Start Date: 2017-08-03
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 68727-745-02 [68727074502]

VYXEOS INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION

• Marketing Category: NDA
• Application Number: NDA209401
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2017-08-03

NDC 68727-745-01 [68727074501]

VYXEOS INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION

• Marketing Category: NDA
• Application Number: NDA209401
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2017-08-03

NDC 68727-745-05 [68727074505]

VYXEOS INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION

• Marketing Category: NDA
• Application Number: NDA209401
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2017-08-03

Drug Details

Active Ingredients

Ingredient	Strength
CYTARABINE	100 mg/20mL

OpenFDA Data

• SPL SET ID: 7ea701ce-e7d3-4349-a9c2-642a501d45c8
• Manufacturer:
  • Jazz Pharmaceuticals, Inc.
• UNII:
  • 04079A1RDZ
  • ZS7284E0ZP
• RxNorm Concept Unique ID - RxCUI:
  • 1942748
  • 1942743

Pharmacological Class

• Nucleic Acid Synthesis Inhibitors [MoA]
• Nucleoside Metabolic Inhibitor [EPC]
• Anthracycline Topoisomerase Inhibitor [EPC]
• Anthracyclines [CS]
• Topoisomerase Inhibitors [MoA]