Prescription drug · ANDA
Doxorubicin Hydrochloride NDC 68001-493
Doxorubicin hydrochloride 2 mg/mL · Injectable, Liposomal · Intravenous · BluePoint Laboratories
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68001-493-26 | 68001049326 | 1 VIAL, SINGLE-DOSE in 1 PACKAGE (68001-493-26) / 25 mL in 1 VIAL, SINGLE-DOSEMarketed from May 31, 2021 |
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 203263
- Marketing start
- Listing expires
- Other FDA classes
- Anthracyclines (Chemical structure)Topoisomerase Inhibitors (Mechanism)
- Identifiers
- Product ID 68001-493_525648ca-bf98-83d3-e063-6394a90a651bSPL ID 525648ca-bf98-83d3-e063-6394a90a651bSPL set ID f6508535-e7a7-4e50-8d0c-43deda8d0d08RxCUI 1790115, 1790127UNII 82F2G7BL4EUPC 0368001493260, 0368001492362
- 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
N468001049326followed by a unit qualifier and the quantityPackage 68001-0493-26. 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 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 Doxorubicin hydrochloride liposom…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 203263
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 |
|---|---|---|---|---|
| Doxorubicin Hydrochloride | Doxorubicin hydrochloride 2 mg/mL | Injectable, LiposomalIntravenous | NorthStar RxLLC | 72603-200 |
| Doxorubicin Hydrochloride | Doxorubicin hydrochloride 2 mg/mL | Injectable, LiposomalIntravenous | Sun Pharmaceutical Industries, Inc. | 47335-050 |
| Doxorubicin Hydrochloride | Doxorubicin hydrochloride 2 mg/mL | Injectable, LiposomalIntravenous | Sun Pharmaceutical Industries, Inc. | 47335-049 |
| Doxorubicin Hydrochloride | Doxorubicin hydrochloride 2 mg/mL | Injectable, LiposomalIntravenous | BluePoint Laboratories | 68001-492 |
| Doxorubicin Hydrochloride | Doxorubicin hydrochloride 2 mg/mL | Injectable, LiposomalIntravenous | NorthStar RxLLC | 72603-103 |