Ethyol

Product NDC: 76310-017
Requested package NDC: 76310-017-50
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	76310-017	76310-017-50	D	Discontinued by firm		2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 10 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`

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#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020221-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020221-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020221-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020221-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020221-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020221-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020221-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020221-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020221-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020221-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020221-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020221-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020221-001	AP	1	`ea99ee380514…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020221-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020221-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020221-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020221-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020221-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020221-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020221-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N020221-001	AP	1	`cb3db0bc1861…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
76310-017-01	EA - Each	76310-017	259a5cb0-cef5-48df-bb8f-c85ec6f1ee4c	1	2020-02-13
76310-017-50	EA - Each	76310-017	b45ab649-f688-4616-abac-8bf5c43da02f	1	2020-02-13

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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ethyol	AMIFOSTINE	Legacy Pharma USA Inc.	a17563f2-d231-4385-bc94-0217be78b89d	2026-03-03	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020221 application number: NDA020221

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
M487QF2F4V	AMIFOSTINE	112901-68-5	AMIFOSTINE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
76310-017-50	76310001750	3 VIAL, SINGLE-USE in 1 CARTON (76310-017-50) > 10 mL in 1 VIAL, SINGLE-USE (76310-017-01)	2020-01-01	0000-00-00	No	No	Current