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NDC 76310-0017-50 Ethyol 500 mg/10mL Details
Ethyol 500 mg/10mL
Ethyol is a INTRAVENOUS INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Clinigen Limited. The primary component is AMIFOSTINE.
MedlinePlus Drug Summary
Amifostine is used protect the kidneys from harmful effects of the chemotherapy drug cisplatin in patients that receive this medication for the treatment of ovarian cancer. Amifostine is also used to decrease dryness in the mouth caused by radiation treatment after surgery for head and neck cancer. Amifostine is in a class of medications called cytoprotectants. It works by protecting against the harmful effects of chemotherapy medications and radiation treatment.
Related Packages: 76310-0017-50Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Amifostine Injection
Product Information
| NDC | 76310-0017 |
|---|---|
| Product ID | 76310-017_26e61d61-cc06-49d2-ab32-e4da8ae7a6aa |
| Associated GPIs | 21758010002120 |
| GCN Sequence Number | 031123 |
| GCN Sequence Number Description | amifostine crystalline VIAL 500 MG INTRAVEN |
| HIC3 | V1I |
| HIC3 Description | CHEMOTHERAPY RESCUE/ANTIDOTE AGENTS |
| GCN | 36901 |
| HICL Sequence Number | 013015 |
| HICL Sequence Number Description | AMIFOSTINE CRYSTALLINE |
| Brand/Generic | Brand |
| Proprietary Name | Ethyol |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | amifostine |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION |
| Route | INTRAVENOUS |
| Active Ingredient Strength | 500 |
| Active Ingredient Units | mg/10mL |
| Substance Name | AMIFOSTINE |
| Labeler Name | Clinigen Limited |
| Pharmaceutical Class | Cytoprotective Agent [EPC], Free Radical Scavenging Activity [MoA] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA020221 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 76310-0017-50 (76310001750)
| NDC Package Code | 76310-017-50 |
|---|---|
| Billing NDC | 76310001750 |
| Package | 3 VIAL, SINGLE-USE in 1 CARTON (76310-017-50) / 10 mL in 1 VIAL, SINGLE-USE (76310-017-01) |
| Marketing Start Date | 2020-01-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |