Ethyol
- Product NDC
- 66220-017
- 11-digit product format
- 662200017
- Labeler code
- 66220
- Product ID
- 66220-017_c4000d7d-d69e-4c5b-b1d8-7a2a97476583
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- amifostine
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Cumberland Pharmaceuticals Inc.
- Application
- NDA020221
- Marketing category
- NDA
- Marketing start
- 2016-08-01
- Marketing end
- 2020-10-31
- Substance
- AMIFOSTINE
- Active strength
- 500 mg/10mL
- Pharmacologic classes
- Cytoprotective Agent [EPC],Free Radical Scavenging Activity [MoA]
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 66220-017 | D | Discontinued by firm | 2026-07-31 | ||
| excluded package | package | 66220-017 | 66220-017-03 | D | Discontinued by firm | 2026-07-31 |
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| N020221-001 | ETHYOL | AMIFOSTINE | 500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, RS | 1995-12-08 | |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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-01 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.
| 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 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 66220-017-03 | EA - Each | 66220-017 | 34dab804-4b86-4bbf-80ec-a3c17154b636 | 1 | 2016-09-02 |