edaravone
- Product NDC
- 39822-4510
- 11-digit product format
- 398224510
- Labeler code
- 39822
- Product ID
- 39822-4510_316d0e19-cb92-1e55-e063-6294a90ab687
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- edaravone
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- XGen Pharmaceuticals DJB, Inc.
- Application
- ANDA217565
- Marketing category
- ANDA
- Marketing start
- 2024-12-02
- Marketing end
- 2026-09-30
- Substance
- EDARAVONE
- Active strength
- 60 mg/100mL
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- edaravone
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| EDARAVONE | 60 mg/100mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | S798V6YJRP |
| Rxcui | 1924316, 2681044 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 39822-4510-1 | edaravone | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 4 |
| 39822-4510-1 | edaravone | 100 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 100 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 39822-4510 | EDARAVONE INJECTION, SOLUTION [XGEN PHARMACEUTICALS DJB, INC.] | 3 | Current NDC, 2 package rows | 20250424_a8245a98-2ccb-4062-b865-3aa348351b48.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 39822-4510-1 | 39822451001 | 1 VIAL, SINGLE-DOSE in 1 CARTON (39822-4510-1) / 100 mL in 1 VIAL, SINGLE-DOSE | 2024-12-02 | 2026-09-30 | No | No | Historical |