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
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.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 76310-017 | D | Discontinued by firm | 2026-08-17 | ||
| 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.
| Captured / source date | Dataset | Scope | Package NDC | Code | Status | Archive | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | D | Discontinued by firm | excluded / ndc_excluded.zip | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 76310-017-50 | D | Discontinued by firm | excluded / ndc_excluded.zip | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | D | Discontinued by firm | excluded / ndc_excluded.zip | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 76310-017-50 | D | Discontinued by firm | excluded / ndc_excluded.zip | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | D | Discontinued by firm | excluded / ndc_excluded.zip | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 76310-017-50 | D | Discontinued by firm | excluded / ndc_excluded.zip | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | D | Discontinued by firm | excluded / ndc_excluded.zip | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 76310-017-50 | D | Discontinued by firm | excluded / ndc_excluded.zip | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | D | Discontinued by firm | excluded / ndc_excluded.zip | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 76310-017-50 | D | Discontinued by firm | excluded / ndc_excluded.zip | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | D | Discontinued by firm | excluded / ndc_excluded.zip | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 76310-017-50 | D | Discontinued by firm | excluded / ndc_excluded.zip | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | D | Discontinued by firm | excluded / ndc_excluded.zip | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 76310-017-50 | D | Discontinued by firm | excluded / ndc_excluded.zip | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | D | Discontinued by firm | excluded / ndc_excluded.zip | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 76310-017-50 | D | Discontinued by firm | excluded / ndc_excluded.zip | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | D | Discontinued by firm | excluded / ndc_excluded.zip | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 76310-017-50 | D | Discontinued by firm | excluded / ndc_excluded.zip | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded product | product | D | Discontinued by firm | excluded / ndc_excluded.zip | ad56d346431e… | cc804d4bbf1e… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 76310-017-50 | D | Discontinued by firm | excluded / ndc_excluded.zip | ad56d346431e… | cc804d4bbf1e… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | unfinished product | product | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | 8d62ce987f31… | 9fe9ef23e30d… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | unfinished package | package | 76310-017-21 | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | 8d62ce987f31… | 9fe9ef23e30d… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | unfinished package | package | 76310-017-07 | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | 8d62ce987f31… | 9fe9ef23e30d… |
| 2024-05-28 21:11 UTC · source 2024-05-28 | unfinished product | product | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | d1e113ab4d42… | 063ee3eb0a1d… | |
| 2024-05-28 21:11 UTC · source 2024-05-28 | unfinished package | package | 76310-017-21 | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | d1e113ab4d42… | 063ee3eb0a1d… |
| 2024-05-28 21:11 UTC · source 2024-05-28 | unfinished package | package | 76310-017-07 | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | d1e113ab4d42… | 063ee3eb0a1d… |
| 2024-05-15 03:51 UTC · source 2024-05-14 | unfinished product | product | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | 50b4072663b7… | eae3003ed65e… | |
| 2024-05-15 03:51 UTC · source 2024-05-14 | unfinished package | package | 76310-017-21 | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | 50b4072663b7… | eae3003ed65e… |
| 2024-05-15 03:51 UTC · source 2024-05-14 | unfinished package | package | 76310-017-07 | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | 50b4072663b7… | eae3003ed65e… |
| 2022-04-09 23:13 UTC · source 2022-04-08 | unfinished product | product | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | 906f6e251498… | bf70b80e44f0… | |
| 2022-04-09 23:13 UTC · source 2022-04-08 | unfinished package | package | 76310-017-07 | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | 906f6e251498… | bf70b80e44f0… |
| 2022-04-09 23:13 UTC · source 2022-04-08 | unfinished package | package | 76310-017-21 | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | 906f6e251498… | bf70b80e44f0… |
| 2021-12-27 23:28 UTC · source 2021-12-27 | unfinished product | product | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | 6db9cb8d1e19… | 3449e1ec5b70… | |
| 2021-12-27 23:28 UTC · source 2021-12-27 | unfinished package | package | 76310-017-21 | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | 6db9cb8d1e19… | 3449e1ec5b70… |
| 2021-12-27 23:28 UTC · source 2021-12-27 | unfinished package | package | 76310-017-07 | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | 6db9cb8d1e19… | 3449e1ec5b70… |
| 2021-02-18 23:40 UTC · source 2021-02-18 | unfinished product | product | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | 8fc7167e32ce… | e96bbc724034… | |
| 2021-02-18 23:40 UTC · source 2021-02-18 | unfinished package | package | 76310-017-21 | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | 8fc7167e32ce… | e96bbc724034… |
| 2021-02-18 23:40 UTC · source 2021-02-18 | unfinished package | package | 76310-017-07 | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | 8fc7167e32ce… | e96bbc724034… |
| 2020-12-18 03:04 UTC · source 2020-12-17 | unfinished product | product | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | 4184dd79f89f… | 545327b3e20f… | |
| 2020-12-18 03:04 UTC · source 2020-12-17 | unfinished package | package | 76310-017-07 | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | 4184dd79f89f… | 545327b3e20f… |
| 2020-12-18 03:04 UTC · source 2020-12-17 | unfinished package | package | 76310-017-21 | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | 4184dd79f89f… | 545327b3e20f… |
| 2020-06-10 20:45 UTC · source 2020-06-10 | unfinished product | product | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | 4bd3596a7b87… | 5c64c6f6865f… | |
| 2020-06-10 20:45 UTC · source 2020-06-10 | unfinished package | package | 76310-017-07 | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | 4bd3596a7b87… | 5c64c6f6865f… |
| 2020-06-10 20:45 UTC · source 2020-06-10 | unfinished package | package | 76310-017-21 | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | 4bd3596a7b87… | 5c64c6f6865f… |
| 2019-12-08 06:16 UTC · source 2019-12-05 | unfinished product | product | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | 263afe128892… | 91768de4ddbe… | |
| 2019-12-08 06:16 UTC · source 2019-12-05 | unfinished package | package | 76310-017-21 | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | 263afe128892… | 91768de4ddbe… |
| 2019-12-08 06:16 UTC · source 2019-12-05 | unfinished package | package | 76310-017-07 | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | 263afe128892… | 91768de4ddbe… |
| 2019-06-01 22:24 UTC · source 2019-05-30 | unfinished product | product | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | 5b2001dcd8f5… | 54b53d4dc9e4… | |
| 2019-06-01 22:24 UTC · source 2019-05-30 | unfinished package | package | 76310-017-21 | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | 5b2001dcd8f5… | 54b53d4dc9e4… |
| 2019-06-01 22:24 UTC · source 2019-05-30 | unfinished package | package | 76310-017-07 | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | 5b2001dcd8f5… | 54b53d4dc9e4… |
Orange Book products#
| 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 | 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 | 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 | 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.
| 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 | 020221 NDA020221 |
Packages#
| 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 |