Ethyol

Product NDC
76310-017
11-digit product format
763100017
Labeler code
76310
Product ID
76310-017_cc8db98c-87bc-461f-8d88-8fbf482c6a3c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
amifostine
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Clinigen Limited
Application
NDA020221
Marketing category
NDA
Marketing start
2020-01-01
Marketing end
0000-00-00
Substance
AMIFOSTINE
Active strength
500 mg/10mL
Pharmacologic classes
Cytoprotective Agent [EPC], Free Radical Scavenging Activity [MoA]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76310-017-01EA - Each76310-017259a5cb0-cef5-48df-bb8f-c85ec6f1ee4c12020-02-13
76310-017-50EA - Each76310-017b45ab649-f688-4616-abac-8bf5c43da02f12020-02-13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
76310-017-50763100017503 VIAL, SINGLE-USE in 1 CARTON (76310-017-50) > 10 mL in 1 VIAL, SINGLE-USE (76310-017-01) 2020-01-010000-00-00NoNoCurrent