edaravone
- Product NDC
- 68083-501
- 11-digit product format
- 680830501
- Labeler code
- 68083
- Product ID
- 68083-501_57566e6e-e90a-4fdf-b23c-d8af19893fd2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- edaravone
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Gland Pharma Limited
- Application
- ANDA216199
- Marketing category
- ANDA
- Marketing start
- 2024-05-06
- 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
- Listing expiration
- 2026-12-31
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 |
|---|
| 68083-501-01 | edaravone | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 4 |
| 68083-501-01 | edaravone | 1 in 1 POUCH | INJECTION, SOLUTION | 1 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68083-501 | EDARAVONE INJECTION, SOLUTION [GLAND PHARMA LIMITED] | 4 | Current NDC, 2 package rows | 20240509_46452eb5-db17-400d-b25b-11844a11e711.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 |
|---|
| 68083-501-01 | 68083050101 | 1 POUCH in 1 CARTON (68083-501-01) / 1 BAG in 1 POUCH / 100 mL in 1 BAG | 1 pouch | 2024-05-06 | No | No | Current |