NDC 76310-017

Ethyol

Amifostine

Ethyol is a Intravenous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Clinigen Group Plc. The primary component is Amifostine.

• Product ID: 76310-017_98f8dd38-f884-45e3-808c-6d8f1187b075
• NDC: 76310-017
• Product Type: Human Prescription Drug
• Proprietary Name: Ethyol
• Generic Name: Amifostine
• Dosage Form: Injection, Powder, Lyophilized, For Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2020-01-01
• Marketing Category: NDA / DRUG FOR FURTHER PROCESSING
• Application Number: NDA020221
• Labeler Name: Clinigen Group PLC
• Substance Name: AMIFOSTINE
• Active Ingredient Strength: 500 mg/10mL
• Pharm Classes: Cytoprotective Agent [EPC],Free Radical Scavenging Activity [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 76310-017-50

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
• Sample Package?: N

NDC SPL Data Element Entries

NDC 76310-017-50 [76310001750]

Ethyol INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: NDA
• Application Number: NDA020221
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2020-01-01

NDC 76310-017-01 [76310001701]

Ethyol INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: NDA
• Application Number: NDA020221
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2020-01-01

Drug Details

Active Ingredients

Ingredient	Strength
AMIFOSTINE	500 mg/10mL

NDC Crossover Matching brand name "Ethyol" or generic name "Amifostine"

NDC	Brand Name	Generic Name
66220-017	Ethyol	amifostine
76310-017	Ethyol	amifostine