BRIVARACETAM
- Product NDC
- 42571-370
- 11-digit product format
- 425710370
- Labeler code
- 42571
- Product ID
- 42571-370_4b90f695-a995-1b76-e063-6294a90a7615
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- BRIVARACETAM
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Micro Labs Limited
- Application
- ANDA214880
- Marketing category
- ANDA
- Marketing start
- 2026-03-01
- Substance
- BRIVARACETAM
- Active strength
- 50 mg/5mL
- Pharmacologic classes
- Epoxide Hydrolase Inhibitors [MoA]
- DEA schedule
- CV
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- BRIVARACETAM
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BRIVARACETAM | 50 mg/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | U863JGG2IA |
| Rxcui | 1739749 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 42571-370-92 | BRIVARACETAM | 5 mL in 1 VIAL | INJECTION | 5 | | 2 |
| 42571-370-99 | BRIVARACETAM | 10 in 1 CARTON | INJECTION | 10 | | 2 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 42571-370-92 | 42571037092 | 5 mL in 1 VIAL | 5 ml | | | | Historical |
| 42571-370-99 | 42571037099 | 10 VIAL in 1 CARTON (42571-370-99) / 5 mL in 1 VIAL (42571-370-92) | 10 vial | 2026-03-01 | No | No | Current |