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 42 .
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date N020221-001 ETHYOL AMIFOSTINE 500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD, RS 1995-12-08 N020221-002 ETHYOL AMIFOSTINE 375MG/VIAL INJECTABLE / INJECTION 1999-09-10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.
Product history page 1 of 3 · 84 observed 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 2026-08-18 06:07:40 2026-07 N020221-001 ETHYOL 500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD, RS 1995-12-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020221-002 ETHYOL 375MG/VIAL INJECTABLE / INJECTION 1999-09-10 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N020221-001 ETHYOL 500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1995-12-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020221-002 ETHYOL 375MG/VIAL INJECTABLE / INJECTION 1999-09-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020221-001 ETHYOL 500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1995-12-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020221-002 ETHYOL 375MG/VIAL INJECTABLE / INJECTION 1999-09-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020221-001 ETHYOL 500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1995-12-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020221-002 ETHYOL 375MG/VIAL INJECTABLE / INJECTION 1999-09-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020221-001 ETHYOL 500MG/VIAL INJECTABLE / INJECTION RLD 1995-12-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020221-002 ETHYOL 375MG/VIAL INJECTABLE / INJECTION 1999-09-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020221-001 ETHYOL 500MG/VIAL INJECTABLE / INJECTION RLD 1995-12-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020221-002 ETHYOL 375MG/VIAL INJECTABLE / INJECTION 1999-09-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020221-001 ETHYOL 500MG/VIAL INJECTABLE / INJECTION RLD 1995-12-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020221-002 ETHYOL 375MG/VIAL INJECTABLE / INJECTION 1999-09-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020221-001 ETHYOL 500MG/VIAL INJECTABLE / INJECTION RLD 1995-12-08 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020221-002 ETHYOL 375MG/VIAL INJECTABLE / INJECTION 1999-09-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020221-001 ETHYOL 500MG/VIAL INJECTABLE / INJECTION RLD, RS 1995-12-08 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020221-002 ETHYOL 375MG/VIAL INJECTABLE / INJECTION 1999-09-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020221-001 ETHYOL 500MG/VIAL INJECTABLE / INJECTION RLD 1995-12-08 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020221-002 ETHYOL 375MG/VIAL INJECTABLE / INJECTION 1999-09-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020221-001 ETHYOL 500MG/VIAL INJECTABLE / INJECTION RLD, RS 1995-12-08 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020221-002 ETHYOL 375MG/VIAL INJECTABLE / INJECTION 1999-09-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020221-001 ETHYOL 500MG/VIAL INJECTABLE / INJECTION RLD, RS 1995-12-08 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020221-002 ETHYOL 375MG/VIAL INJECTABLE / INJECTION 1999-09-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020221-001 ETHYOL 500MG/VIAL INJECTABLE / INJECTION RLD, RS 1995-12-08 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020221-002 ETHYOL 375MG/VIAL INJECTABLE / INJECTION 1999-09-10 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020221-001 ETHYOL 500MG/VIAL INJECTABLE / INJECTION RLD, RS 1995-12-08 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020221-002 ETHYOL 375MG/VIAL INJECTABLE / INJECTION 1999-09-10 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020221-001 ETHYOL 500MG/VIAL INJECTABLE / INJECTION RLD, RS 1995-12-08 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N020221-002 ETHYOL 375MG/VIAL INJECTABLE / INJECTION 1999-09-10 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020221-001 ETHYOL 500MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1995-12-08 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020221-002 ETHYOL 375MG/VIAL INJECTABLE / INJECTION 1999-09-10 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020221-001 ETHYOL 500MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1995-12-08 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N020221-002 ETHYOL 375MG/VIAL INJECTABLE / INJECTION 1999-09-10 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020221-001 ETHYOL 500MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1995-12-08 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N020221-002 ETHYOL 375MG/VIAL INJECTABLE / INJECTION 1999-09-10 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020221-001 ETHYOL 500MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1995-12-08 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N020221-002 ETHYOL 375MG/VIAL INJECTABLE / INJECTION 1999-09-10 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020221-001 ETHYOL 500MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1995-12-08 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N020221-002 ETHYOL 375MG/VIAL INJECTABLE / INJECTION 1999-09-10 bb7c543d1eb4…
Observed Orange Book normalized TE history# 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
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
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