vyxeos

Generic: (daunorubicin and cytarabine) liposome

Labeler: jazz pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name vyxeos
Generic Name (daunorubicin and cytarabine) liposome
Labeler jazz pharmaceuticals, inc.
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION
Routes
INTRAVENOUS
Active Ingredients

cytarabine 100 mg/20mL, daunorubicin 44 mg/20mL

Manufacturer
Jazz Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 68727-745
Product ID 68727-745_25abb1d8-f921-4aae-8240-1914cd80417a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA209401
Listing Expiration 2027-12-31
Marketing Start 2017-08-03

Pharmacologic Class

Established (EPC)
nucleoside metabolic inhibitor [epc] anthracycline topoisomerase inhibitor [epc]
Mechanism of Action
nucleic acid synthesis inhibitors [moa] topoisomerase inhibitors [moa]
Chemical Structure
anthracyclines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68727745
Hyphenated Format 68727-745

Supplemental Identifiers

RxCUI
1942743 1942748
UNII
04079A1RDZ ZS7284E0ZP
NUI
N0000000233 N0000175595 N0000175414 M0028312 N0000000176

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name vyxeos (source: ndc)
Generic Name (daunorubicin and cytarabine) liposome (source: ndc)
Application Number NDA209401 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 100 mg/20mL
  • 44 mg/20mL
source: ndc
Packaging
  • 20 mL in 1 VIAL (68727-745-01)
  • 40 mL in 1 CARTON (68727-745-02)
source: ndc

Packages (2)

68727-745-01 20 mL in 1 VIAL (68727-745-01) 68727-745-02 40 mL in 1 CARTON (68727-745-02)

Ingredients (2)

cytarabine (100 mg/20mL) daunorubicin (44 mg/20mL)

Linked Drug Pages (1)

VYXEOS ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "25abb1d8-f921-4aae-8240-1914cd80417a", "openfda": {"nui": ["N0000000233", "N0000175595", "N0000175414", "M0028312", "N0000000176"], "unii": ["04079A1RDZ", "ZS7284E0ZP"], "rxcui": ["1942743", "1942748"], "spl_set_id": ["7ea701ce-e7d3-4349-a9c2-642a501d45c8"], "pharm_class_cs": ["Anthracyclines [CS]"], "pharm_class_epc": ["Nucleoside Metabolic Inhibitor [EPC]", "Anthracycline Topoisomerase Inhibitor [EPC]"], "pharm_class_moa": ["Nucleic Acid Synthesis Inhibitors [MoA]", "Topoisomerase Inhibitors [MoA]"], "manufacturer_name": ["Jazz Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "20 mL in 1 VIAL (68727-745-01)", "package_ndc": "68727-745-01", "marketing_start_date": "20170803"}, {"sample": false, "description": "40 mL in 1 CARTON (68727-745-02)", "package_ndc": "68727-745-02", "marketing_start_date": "20170803"}], "brand_name": "VYXEOS", "product_id": "68727-745_25abb1d8-f921-4aae-8240-1914cd80417a", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION", "pharm_class": ["Anthracycline Topoisomerase Inhibitor [EPC]", "Anthracyclines [CS]", "Nucleic Acid Synthesis Inhibitors [MoA]", "Nucleoside Metabolic Inhibitor [EPC]", "Topoisomerase Inhibitors [MoA]"], "product_ndc": "68727-745", "generic_name": "(daunorubicin and cytarabine) liposome", "labeler_name": "Jazz Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "VYXEOS", "active_ingredients": [{"name": "CYTARABINE", "strength": "100 mg/20mL"}, {"name": "DAUNORUBICIN", "strength": "44 mg/20mL"}], "application_number": "NDA209401", "marketing_category": "NDA", "marketing_start_date": "20170803", "listing_expiration_date": "20271231"}