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
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 Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | M487QF2F4V |
| Rxcui | 308096, 1803018 |
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 |