NDC codes

FDA NDC Directory
Product NDC (as listed)68727-745Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68727-0745Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
68727-745-01687270745016872707450120 mL in 1 VIAL (68727-745-01)Marketed from Aug 3, 2017
68727-745-02687270745026872707450240 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.

How CPT relates to drug billing

NDC on a medical claim

N468727074501 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

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.

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