Edaravone
- Product NDC
- 66794-259
- 11-digit product format
- 667940259
- Labeler code
- 66794
- Product ID
- 66794-259_40905b35-f5ad-1c99-e063-6294a90a22d4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Edaravone
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Piramal Critical Care Inc.
- Application
- ANDA216199
- Marketing category
- ANDA
- Marketing start
- 2024-07-08
- Substance
- EDARAVONE
- Active strength
- 30 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
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| EDARAVONE | 30 mg/100mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | S798V6YJRP |
| Rxcui | 1924316 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 66794-259-64 | Edaravone | 1 in 1 POUCH | INJECTION, SOLUTION | 1 | | 3 |
| 66794-259-64 | Edaravone | 2 in 1 CARTON | INJECTION, SOLUTION | 2 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 66794-259 | EDARAVONE INJECTION, SOLUTION [PIRAMAL CRITICAL CARE INC.] | 2 | Current NDC, 2 package rows | 20240708_19862ae9-d6e1-70e6-e063-6394a90ae749.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 |
|---|
| 66794-259-64 | 66794025964 | 2 POUCH in 1 CARTON (66794-259-64) / 1 BAG in 1 POUCH / 100 mL in 1 BAG | 2 pouch | 2024-07-08 | No | No | Current |