Prescription drug · NDA
Vyxeos ((daunorubicin and cytarabine) liposome) NDC 68727-745
Cytarabine 100 mg/20mL; Daunorubicin 44 mg/20mL · Injection, Powder, Lyophilized, For suspension · Intravenous · Jazz Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68727-745-01 | 6872707450168727074501 | 20 mL in 1 VIAL (68727-745-01)Marketed from Aug 3, 2017 | |
| 68727-745-02 | 6872707450268727074502 | 40 mL in 1 CARTON (68727-745-02)Marketed from Aug 3, 2017 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Vyxeos
- Generic name (nonproprietary)
- (daunorubicin and cytarabine) liposome
- Active ingredients
- Cytarabine — 100 mg/20mLDaunorubicin — 44 mg/20mL
- Dosage form
- Injection, Powder, Lyophilized, For suspension
- Route
- Intravenous
- Labeler
- Jazz Pharmaceuticals, Inc.NDC labeler code 68727
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 209401
- Marketing start
- Listing expires
- Other FDA classes
- Anthracyclines (Chemical structure)Nucleic Acid Synthesis Inhibitors (Mechanism)Topoisomerase Inhibitors (Mechanism)
- Identifiers
- Product ID 68727-745_25abb1d8-f921-4aae-8240-1914cd80417aSPL ID 25abb1d8-f921-4aae-8240-1914cd80417aSPL set ID 7ea701ce-e7d3-4349-a9c2-642a501d45c8RxCUI 1942743, 1942748UNII 04079A1RDZ, ZS7284E0ZP
- Pharmacologic class
- Anthracycline Topoisomerase Inhibitor; Nucleoside Metabolic Inhibitor
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N468727074501followed by a unit qualifier and the quantityPackage 68727-0745-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
VYXEOS is indicated for the treatment of newly diagnosed therapy-related acute myeloid leukemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC) in adults and pediatric patients 1 year and older. VYXEOS is a liposomal combination of daunorubicin, an anthracycline topoisomerase inhibitor, and cytarabine, a nucleoside metabolic inhibitor, that is indicated for the treatment of newly diagnosed therapy-related acute myeloid leukemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC) in adults and pediatric patients 1 year and older. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 68727-745
- What is NDC 68727-745?
- 68727-745 is the product NDC for Vyxeos, Cytarabine 100 mg/20mL; Daunorubicin 44 mg/20mL injection, powder, lyophilized, for suspension, listed with the FDA by Jazz Pharmaceuticals, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Vyxeos ((daunorubicin and cytarabine) liposome).
- What is the active ingredient?
- Cytarabine, Daunorubicin.
- Who is the labeler?
- Jazz Pharmaceuticals, Inc., NDC labeler code 68727. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Vyxeos?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.