NDC 66220-017

Ethyol

Amifostine

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

• Product ID: 66220-017_3b758dd1-471c-4ab5-8eb7-b0a99c6241b4
• NDC: 66220-017
• 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: 2016-08-01
• Marketing Category: NDA / NDA
• Application Number: NDA020221
• Labeler Name: Cumberland Pharmaceuticals Inc.
• 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: 2019-12-31

Packaging

NDC 66220-017-03

3 VIAL, SINGLE-USE in 1 CARTON (66220-017-03) > 10 mL in 1 VIAL, SINGLE-USE

• Marketing Start Date: 2016-08-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 66220-017-03 [66220001703]

Ethyol INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: NDA
• Application Number: NDA020221
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2016-08-01
• Marketing End Date: 2020-10-31

Drug Details

Active Ingredients

Ingredient	Strength
AMIFOSTINE	500 mg/10mL

OpenFDA Data

• SPL SET ID: f11c0753-ef0a-4e1b-83dd-8543649df9a5
• Manufacturer:
  • Cumberland Pharmaceuticals Inc.
• UNII:
  • M487QF2F4V
• RxNorm Concept Unique ID - RxCUI:
  • 1803018
  • 308096

Pharmacological Class

• Cytoprotective Agent [EPC]
• Free Radical Scavenging Activity [MoA]

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

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