Edaravone
- Product NDC
- 0781-3527
- 11-digit product format
- 007813527
- Labeler code
- 0781
- Product ID
- 0781-3527_ae940bc6-1e6a-4b76-825c-bd2e1925e39a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Edaravone
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Sandoz Inc
- Application
- ANDA216902
- Marketing category
- ANDA
- Marketing start
- 2025-01-21
- 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 |
|---|
| 0781-3527-20 | Edaravone | 2 in 1 CARTON | INJECTION | 2 | | 1 |
| 0781-3527-94 | Edaravone | 100 mL in 1 BAG | INJECTION | 100 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0781-3527 | EDARAVONE INJECTION [SANDOZ INC] | 1 | Current NDC, 2 package rows | 20250121_ae940bc6-1e6a-4b76-825c-bd2e1925e39a.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 |
|---|
| 0781-3527-20 | 00781352720 | 2 BAG in 1 CARTON (0781-3527-20) / 100 mL in 1 BAG (0781-3527-94) | 2 bag | 2025-01-21 | No | No | Current |
| 0781-3527-94 | 00781352794 | 100 mL in 1 BAG | 100 ml | | | | Historical |