Prescription drug · UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE
doxorubicin hydrochloride, Liposomal (Doxorubicin hydrochloride) NDC 0338-9581
Doxorubicin hydrochloride 2 mg/mL · Injection, Suspension, Liposomal · Intravenous · Baxter Healthcare Corporation
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0338-9581-02 | 0033895810200338958102 | 1 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
- Labeler
- Baxter Healthcare CorporationNDC labeler code 0338
- 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.
- NDC on a medical claim
N400338958102followed by a unit qualifier and the quantityPackage 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 .
About NDC 0338-9581
- What is NDC 0338-9581?
- 0338-9581 is the product NDC for doxorubicin hydrochloride, Liposomal, Doxorubicin hydrochloride 2 mg/mL injection, suspension, liposomal, listed with the FDA by Baxter Healthcare Corporation. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- doxorubicin hydrochloride, Liposomal (Doxorubicin hydrochloride).
- What is the active ingredient?
- Doxorubicin hydrochloride.
- Who is the labeler?
- Baxter Healthcare Corporation, NDC labeler code 0338. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for doxorubicin hydrochloride, Liposomal?
- 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.