Prescription drug · ANDA
Doxorubicin Hydrochloride NDC 68001-345
Doxorubicin hydrochloride 2 mg/mL · Injectable, Liposomal · Intravenous · BluePoint Laboratories
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68001-345-26 | 68001034526 | 1 VIAL, SINGLE-DOSE in 1 CARTON (68001-345-26) / 25 mL in 1 VIAL, SINGLE-DOSEMarketed from Feb 16, 2018 | |
| 68001-345-36 | 68001034536 | 1 VIAL, SINGLE-DOSE in 1 CARTON (68001-345-36) / 10 mL in 1 VIAL, SINGLE-DOSEMarketed from Feb 16, 2018 |
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)
- Doxorubicin Hydrochloride
- Generic name (nonproprietary)
- doxorubicin hydrochloride
- Active ingredients
- Doxorubicin hydrochloride — 2 mg/mL
- Dosage form
- Injectable, Liposomal
- Route
- Intravenous
- Labeler
- BluePoint Laboratories
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 208657
- Marketing start
- Listing expires
- Other FDA classes
- Anthracyclines (Chemical structure)Topoisomerase Inhibitors (Mechanism)
- Identifiers
- Product ID 68001-345_e9b9ead5-4033-1599-e053-2a95a90a0d81SPL ID e9b9ead5-4033-1599-e053-2a95a90a0d81SPL set ID f1a12eb5-5bdc-45f4-843e-0c971535b184RxCUI 1790115, 1790127UNII 82F2G7BL4EUPC 0368001345361, 0368001345262
- 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
N468001034526followed by a unit qualifier and the quantityPackage 68001-0345-26. 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)
Doxorubicin hydrochloride liposome injection 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 Doxorubicin hydrochloride liposome injection 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 Doxorubic…
Excerpt only. Read the full label for complete information.