Avopef
- Product NDC
- 83831-144
- 11-digit product format
- 838310144
- Labeler code
- 83831
- Product ID
- 83831-144_76479cd7-c02c-4dae-87d4-b971fabe74f5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- etoposide
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Avyxa Pharma, LLC
- Application
- NDA220200
- Marketing category
- NDA
- Marketing start
- 2026-04-01
- Substance
- ETOPOSIDE
- Active strength
- 100 mg/5mL
- Pharmacologic classes
- Topoisomerase Inhibitor [EPC], Topoisomerase Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Avopef
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ETOPOSIDE | 100 mg/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 6PLQ3CP4P3 |
| Rxcui | 310248, 2735802 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 83831-144-05 | Avopef | 5 mL in 1 VIAL | INJECTION | 5 | | 7 |
| 83831-144-05 | Avopef | 1 in 1 CARTON | INJECTION | 1 | | 7 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 83831-144-05 | 83831014405 | 1 VIAL in 1 CARTON (83831-144-05) / 5 mL in 1 VIAL | 1 vial | 2026-04-01 | No | No | Current |