Prescription drug · ANDA
Dexrazoxane NDC 55150-437
Kit · Eugia US LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55150-437-01 | 55150043701 | 1 KIT in 1 PACKAGE (55150-437-01) * 50 mL in 1 VIAL, SINGLE-DOSE (55150-435-01) * 50 mL in 1 VIAL (55150-436-01)Marketed from May 12, 2016 |
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
- Dosage form
- Kit
- Labeler
- Eugia US LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 200752
- Marketing start
- Listing expires
- Identifiers
- Product ID 55150-437_f0a2a9ff-2f1f-481b-96c8-404e9d4a60faSPL ID f0a2a9ff-2f1f-481b-96c8-404e9d4a60faSPL set ID be9ac1e9-21a9-439a-9029-9f03513220eaRxCUI 1736585, 1736590
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
N455150043701followed by a unit qualifier and the quantityPackage 55150-0437-01. 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 continue…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 200752
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 |
|---|---|---|---|---|
| Dexrazoxane | — | Kit | Eugia US LLC | 55150-434 |
| Dexrazoxane | — | Kit | Eugia US LLC | 55150-434 |