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NDC 72611-0716-72 Dexrazoxane 500 mg/50mL Details
Dexrazoxane 500 mg/50mL
Dexrazoxane is a INTRAVENOUS INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Almaject, Inc.. The primary component is DEXRAZOXANE HYDROCHLORIDE.
MedlinePlus Drug Summary
Dexrazoxane injection (Totect, Zinecard) is used to prevent or decrease thickening of the heart muscles caused by doxorubicin in women who are taking the medication to treat breast cancer that has spread to other parts of the body. Dexrazoxane injection (Totect, Zinecard) is only given to women who have already received a certain amount of doxorubicin and who will need continued doxorubicin treatment, it is not used to prevent heart damage in women who are starting treatment with doxorubicin. Dexrazoxane injection (Totect) is used to decrease damage to the skin and tissues that may be caused when an anthracycline chemotherapy medication such as daunorubicin (Cerubidine), doxorubicin (Adriamycin, Doxil), epirubicin (Ellence) or idarubicin (Idamycin) leaks out of a vein as it is being injected. Dexrazoxane injection is in classes of medications called cardioprotectants and chemoprotectants. It works by stopping the chemotherapy medications from damaging the heart and the tissues.
Related Packages: 72611-0716-72Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Dexrazoxane Injection
Product Information
| NDC | 72611-0716 |
|---|---|
| Product ID | 72611-716_e961ed48-b0cf-5604-d38c-285e0b8df548 |
| Associated GPIs | 21754040102140 |
| GCN Sequence Number | 036426 |
| GCN Sequence Number Description | dexrazoxane HCl VIAL 500 MG INTRAVEN |
| HIC3 | V1I |
| HIC3 Description | CHEMOTHERAPY RESCUE/ANTIDOTE AGENTS |
| GCN | 95873 |
| HICL Sequence Number | 016635 |
| HICL Sequence Number Description | DEXRAZOXANE HCL |
| Brand/Generic | Generic |
| Proprietary Name | Dexrazoxane |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Dexrazoxane for Injection |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION |
| Route | INTRAVENOUS |
| Active Ingredient Strength | 500 |
| Active Ingredient Units | mg/50mL |
| Substance Name | DEXRAZOXANE HYDROCHLORIDE |
| Labeler Name | Almaject, Inc. |
| Pharmaceutical Class | Cytoprotective Agent [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA207321 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 72611-0716-72 (72611071672)
| NDC Package Code | 72611-716-72 |
|---|---|
| Billing NDC | 72611071672 |
| Package | 1 VIAL, SINGLE-DOSE in 1 CARTON (72611-716-72) / 50 mL in 1 VIAL, SINGLE-DOSE |
| Marketing Start Date | 2022-06-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |