NDC codes

FDA NDC Directory
Product NDC (as listed)0338-9581Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00338-9581Add 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
0338-9581-02003389581021 VIAL, SINGLE-USE in 1 CARTON (0338-9581-02) / 10 mL in 1 VIAL, SINGLE-USE (0338-9581-01)Marketed from Dec 19, 2023

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
doxorubicin hydrochloride, Liposomal
Generic name (nonproprietary)
doxorubicin hydrochloride
Active ingredients
Doxorubicin hydrochloride — 2 mg/mL
Dosage form
Injection, Suspension, Liposomal
Route
Intravenous
Product type
Prescription drug
Marketing category
Unapproved drug for use in drug shortage
Marketing start
Listing expires
Other FDA classes
Anthracyclines (Chemical structure)Topoisomerase Inhibitors (Mechanism)
Identifiers
Product ID 0338-9581_a4227051-225f-49e2-9e5c-653ea0f99739SPL ID a4227051-225f-49e2-9e5c-653ea0f99739SPL set ID b24afa8c-636b-4ace-99d5-51f445ad3123RxCUI 1790115UNII 82F2G7BL4EUPC 5413765812286
Pharmacologic class
Anthracycline Topoisomerase 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

N400338958102 followed by a unit qualifier and the quantity

Package 00338-9581-02. 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 .

Full label on DailyMed (opens in a new tab)

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