Brivaracetam
- Product NDC
- 84386-070
- 11-digit product format
- 843860070
- Labeler code
- 84386
- Product ID
- 84386-070_921bd2d8-0135-469e-8c63-555bc1190234
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Brivaracetam
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Aurobindo Pharma Limited
- Application
- ANDA214848
- Marketing category
- ANDA
- Marketing start
- 2026-02-25
- Substance
- BRIVARACETAM
- Active strength
- 50 mg/1
- 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/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | U863JGG2IA |
| Rxcui | 1739768, 1739776 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 84386-070-60 | Brivaracetam | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 3 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 84386-070-60 | 84386007060 | 60 TABLET, FILM COATED in 1 BOTTLE (84386-070-60) | 2026-02-25 | No | No | Current |