edaravone
- Product NDC
- 39822-4500
- 11-digit product format
- 398224500
- Labeler code
- 39822
- Product ID
- 39822-4500_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
- Substance
- EDARAVONE
- Active strength
- 30 mg/100mL
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 39822-4500-1 | edaravone | 100 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 100 | | 4 |
| 39822-4500-2 | edaravone | 2 in 1 CARTON | INJECTION, SOLUTION | 2 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 39822-4500 | 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 | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 39822-4500-1 | 39822450001 | 100 mL in 1 VIAL, SINGLE-DOSE | 100 ml | | | | Historical |
| 39822-4500-2 | 39822450002 | 2 VIAL, SINGLE-DOSE in 1 CARTON (39822-4500-2) / 100 mL in 1 VIAL, SINGLE-DOSE (39822-4500-1) | | 2024-12-02 | No | No | Historical |