Prescription drug · ANDA
Dexrazoxane (dexrazoxane for injection) NDC 72266-101
Dexrazoxane hydrochloride 500 mg/50mL · Injection, Powder, Lyophilized, For solution · Intravenous · Fosun Pharma USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72266-101-01 | 72266010101 | 1 VIAL in 1 CARTON (72266-101-01) / 50 mL in 1 VIALMarketed from Mar 18, 2019 |
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)
- Dexrazoxane
- Generic name (nonproprietary)
- dexrazoxane for injection
- Active ingredients
- Dexrazoxane hydrochloride — 500 mg/50mL
- Dosage form
- Injection, Powder, Lyophilized, For solution
- Route
- Intravenous
- Labeler
- Fosun Pharma USA Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207321
- Marketing start
- Listing expires
- Identifiers
- Product ID 72266-101_39134f54-58a4-ca41-e063-6394a90ac300SPL ID 39134f54-58a4-ca41-e063-6394a90ac300SPL set ID c1d98fbe-5fd9-4518-b1a5-fac92e32928fRxCUI 1736585, 1736590UNII 5346058Q7SUPC 0372266101013, 0372266235015
- Pharmacologic class
- Cytoprotective Agent
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
N472266010101followed by a unit qualifier and the quantityPackage 72266-0101-01. 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 .
Indications (excerpt from the label)
Dexrazoxane for injection is indicated for reducing the incidence and severity of cardiomyopathy associated with doxorubicin administration in women with metastatic breast cancer who have received a cumulative doxorubicin dose of 300 mg/m 2 and who will continue to receive doxorubicin therapy to maintain tumor control. Do not use with the initiation of doxorubicin therapy [see Warnings and Precautions ( 5.2 )] . Dexrazoxane for injection is a cytoprotective agent indicated for reducing the incidence and severity of cardiomyopathy associated with doxorubicin administration in women with metastatic breast cancer who have received a cumulative doxorubicin dose of 300 mg/m 2 and who will continu…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 207321
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 |
|---|---|---|---|---|
| Dexrazoxanedexrazoxane for injection | Dexrazoxane hydrochloride 500 mg/50mL | Injection, Powder, Lyophilized, For solutionIntravenous | Gland Pharma Limited | 68083-195 |
| Dexrazoxanedexrazoxane for injection | Dexrazoxane hydrochloride 250 mg/25mL | Injection, Powder, Lyophilized, For solutionIntravenous | Fosun Pharma USA Inc. | 72266-235 |
| Dexrazoxanedexrazoxane for injection | Dexrazoxane hydrochloride 250 mg/25mL | Injection, Powder, Lyophilized, For solutionIntravenous | Gland Pharma Limited | 68083-388 |
| Dexrazoxanedexrazoxane for injection | Dexrazoxane hydrochloride 500 mg/50mL | Injection, Powder, Lyophilized, For solutionIntravenous | Almaject, Inc. | 72611-716 |
| Dexrazoxanedexrazoxane for injection | Dexrazoxane hydrochloride 500 mg/50mL | Injection, Powder, Lyophilized, For solutionIntravenous | Almaject, Inc. | 72611-716 |