Doxil (doxorubicin hydrochloride) NDC 0338-0063

NDC codes

FDA NDC Directory

Product NDC (as listed)0338-0063Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00338-0063Add 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 NDC	11-digit (billing)	Package	Copy
0338-0063-01	00338006301	1 VIAL, SINGLE-USE in 1 CARTON (0338-0063-01) / 10 mL in 1 VIAL, SINGLE-USEMarketed from Aug 13, 2019

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): Doxil
Generic name (nonproprietary): doxorubicin hydrochloride
Active ingredients: Doxorubicin hydrochloride — 2 mg/mL
Dosage form: Injection, Suspension, Liposomal
Route: Intravenous
Labeler: Baxter Healthcare Company
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 050718
Marketing start: Aug 13, 2019
Listing expires: Dec 31, 2027
Other FDA classes: Anthracyclines (Chemical structure)Topoisomerase Inhibitors (Mechanism)
Identifiers: Product ID 0338-0063_15bd5c62-3eb4-464f-b446-76ab04fa1ab4SPL ID 15bd5c62-3eb4-464f-b446-76ab04fa1ab4SPL set ID 1c153e9e-4cf2-4ac7-9cf9-16f9b48d7dceRxCUI 1790115, 1790127, 1790128, 1790131UNII 82F2G7BL4E
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

N400338006301 followed by a unit qualifier and the quantity

Package 00338-0063-01. 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 May 31, 2022. This label includes a boxed warning.

Indications (excerpt from the label)

Doxil liposomal infusion is an anthracycline topoisomerase inhibitor indicated for: • Ovarian cancer: After failure of platinum-based chemotherapy ( 1.1 ) • AIDS-related Kaposi’s Sarcoma: After failure of prior systemic chemotherapy or intolerance to such therapy ( 1.2 ) • Multiple Myeloma: In combination with bortezomib in patients who have not previously received bortezomib and have received at least one prior therapy ( 1.3 ) 1.1 Ovarian Cancer DOXIL liposomal infusion is indicated for the treatment of patients with ovarian cancer whose disease has progressed or recurred after platinum-based chemotherapy. 1.2 AIDS-Related Kaposi’s Sarcoma DOXIL liposomal infusion is indicated for the treat…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 050718

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under NDA 050718
Product	Strength	Form · route	Labeler	Product NDC
Doxorubicin Hydrochloride Liposome	Doxorubicin hydrochloride 2 mg/mL	Injection, Suspension, LiposomalIntravenous	Baxter Healthcare Company	0338-0086
Doxildoxorubicin hydrochloride	Doxorubicin hydrochloride 2 mg/mL	Injection, Suspension, LiposomalIntravitreal	Baxter Healthcare Company	0338-0067
Doxildoxorubicin hydrochloride	Doxorubicin hydrochloride 2 mg/mL	Injection, Suspension, LiposomalIntravenous	Baxter Healthcare Corporation	0338-9665
Doxildoxorubicin hydrochloride	Doxorubicin hydrochloride 2 mg/mL	Injection, Suspension, LiposomalIntravenous	Baxter Healthcare Corporation	0338-9667
Doxorubicin Hydrochloride Liposome	Doxorubicin hydrochloride 2 mg/mL	Injection, Suspension, LiposomalIntravenous	Baxter Healthcare Company	0338-0080