Home NDC 83107-030 Ethyol
Product NDC 83107-030
11-digit product format 831070030
Labeler code 83107
Product ID 83107-030_4c20479c-d75a-a0c7-e063-6394a90a9e59
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Amifostine
Dosage form INJECTION
Route INTRAVENOUS
Labeler Legacy Pharma USA Inc.
Application NDA020221
Marketing category NDA
Marketing start 2026-03-16
Substance AMIFOSTINE
Active strength 500 mg/10mL
Pharmacologic classes Cytoprotective Agent [EPC], Free Radical Scavenging Activity [MoA]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N020221-001 ETHYOL AMIFOSTINE 500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD, RS 1995-12-08 N020221-002 ETHYOL AMIFOSTINE 375MG/VIAL INJECTABLE / INJECTION 1999-09-10
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-01 22:54:32 2026-06 N020221-001 ETHYOL 500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD, RS 1995-12-08 a50c72e98297…2026-08-01 22:54:32 2026-06 N020221-002 ETHYOL 375MG/VIAL INJECTABLE / INJECTION 1999-09-10 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base Ethyol
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AMIFOSTINE 500 mg/10mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination M487QF2F4V Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 308096 Internal RxNorm lookup 1803018 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 83107-030-01 Ethyol 10 mL in 1 VIAL, SINGLE-DOSE INJECTION 10 2 83107-030-02 Ethyol 3 in 1 CARTON INJECTION 3 2
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 83107-030-01 83107003001 10 mL in 1 VIAL, SINGLE-DOSE 10 ml Historical 83107-030-02 83107003002 3 VIAL, SINGLE-DOSE in 1 CARTON (83107-030-02) / 10 mL in 1 VIAL, SINGLE-DOSE (83107-030-01) 2026-03-16 No No Current