Prescription drug · NDA
Doxil (Doxorubicin hydrochloride) NDC 0338-0067
Doxorubicin hydrochloride 2 mg/mL · Injection, Suspension, Liposomal · Intravitreal · Baxter Healthcare Company
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0338-0067-01 | 0033800670100338006701 | 1 VIAL, SINGLE-USE in 1 CARTON (0338-0067-01) / 25 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
- Intravitreal
- Labeler
- Baxter Healthcare CompanyNDC labeler code 0338
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 050718
- Marketing start
- Listing expires
- Other FDA classes
- Anthracyclines (Chemical structure)Topoisomerase Inhibitors (Mechanism)
- Identifiers
- Product ID 0338-0067_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.
- NDC on a medical claim
N400338006701followed by a unit qualifier and the quantityPackage 00338-0067-01. 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)
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.
About NDC 0338-0067
- What is NDC 0338-0067?
- 0338-0067 is the product NDC for Doxil (doxorubicin hydrochloride), Doxorubicin hydrochloride 2 mg/mL injection, suspension, liposomal, listed with the FDA by Baxter Healthcare Company. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Doxil (Doxorubicin hydrochloride).
- What is the active ingredient?
- Doxorubicin hydrochloride.
- Who is the labeler?
- Baxter Healthcare Company, 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 Doxil?
- 3 other product NDCs are listed under this name. See all Doxil NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Doxil products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Doxildoxorubicin hydrochloride | Doxorubicin hydrochloride 2 mg/mL | Injection, Suspension, LiposomalIntravenous | Baxter Healthcare Corporation | 0338-9665 | 00338-9665-01 |
| Doxildoxorubicin hydrochloride | Doxorubicin hydrochloride 2 mg/mL | Injection, Suspension, LiposomalIntravenous | Baxter Healthcare Corporation | 0338-9667 | 00338-9667-01 |
| Doxildoxorubicin hydrochloride | Doxorubicin hydrochloride 2 mg/mL | Injection, Suspension, LiposomalIntravenous | Baxter Healthcare Company | 0338-0063 | 00338-0063-01 |
Other NDCs under NDA 050718
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Doxildoxorubicin hydrochloride | Doxorubicin hydrochloride 2 mg/mL | Injection, Suspension, LiposomalIntravenous | Baxter Healthcare Company | 0338-0063 |
| 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 |
| Doxorubicin Hydrochloride Liposome | Doxorubicin hydrochloride 2 mg/mL | Injection, Suspension, LiposomalIntravenous | Baxter Healthcare Company | 0338-0086 |