Prescription drug · ANDA
doxorubicin hydrochloride NDC 25021-207
Doxorubicin hydrochloride 2 mg/mL · Injection, Solution · Intravenous · Sagent Pharmaceuticals
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 25021-207-25 | 25021020725 | 1 VIAL in 1 CARTON (25021-207-25) / 25 mL in 1 VIALMarketed from Oct 31, 2013 | |
| 25021-207-51 | 25021020751 | 1 VIAL in 1 CARTON (25021-207-51) / 100 mL in 1 VIALMarketed from Oct 31, 2013 |
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
- Injection, Solution
- Route
- Intravenous
- Labeler
- Sagent Pharmaceuticals
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209825
- Marketing start
- Listing expires
- Other FDA classes
- Anthracyclines (Chemical structure)Topoisomerase Inhibitors (Mechanism)
- Identifiers
- Product ID 25021-207_f327fef8-8ebd-45a2-a339-72e702c4f8b5SPL ID f327fef8-8ebd-45a2-a339-72e702c4f8b5SPL set ID ae80bd3a-b99a-4e01-a444-b9d05687f00eRxCUI 1191138, 1790100UNII 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.
- NDC on a medical claim
N425021020725followed by a unit qualifier and the quantityPackage 25021-0207-25. 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 Injection is an anthracycline topoisomerase inhibitor indicated: as a component of multiagent adjuvant chemotherapy for treatment of women with axillary lymph node involvement following resection of primary breast cancer ( 1.1 ). for the treatment of: acute lymphoblastic leukemia, acute myeloblastic leukemia, Hodgkin lymphoma, Non-Hodgkin lymphoma, metastatic breast cancer, metastatic Wilms' tumor, metastatic neuroblastoma, metastatic soft tissue sarcoma, metastatic bone sarcomas, metastatic ovarian carcinoma, metastatic transitional cell bladder carcinoma, metastatic thyroid carcinoma, metastatic gastric carcinoma, metastatic bronchogenic carcinoma ( 1.2 ). 1.1 Adj…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 209825
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 | Injection, SolutionIntravenous | Gland Pharma Limited | 68083-249 |
| Doxorubicin Hydrochloride | Doxorubicin hydrochloride 2 mg/mL | Injection, SolutionIntravenous | Gland Pharma Limited | 68083-248 |
| Doxorubicin Hydrochloride | Doxorubicin hydrochloride 2 mg/mL | Injection, SolutionIntravenous | Gland Pharma Limited | 68083-250 |