BRIVARACETAM
- Product NDC
- 70748-411
- 11-digit product format
- 707480411
- Labeler code
- 70748
- Product ID
- 70748-411_6ec38dcf-1e59-40a8-bf47-885308615222
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- brivaracetam
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Lupin Pharmaceuticals, Inc.
- Application
- ANDA220164
- Marketing category
- ANDA
- Marketing start
- 2026-02-23
- Substance
- BRIVARACETAM
- Active strength
- 10 mg/mL
- 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 | 10 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | U863JGG2IA |
| Rxcui | 1739785 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70748-411-01 | BRIVARACETAM | 300 mL in 1 BOTTLE | SOLUTION | 300 | | 5 |
| 70748-411-01 | BRIVARACETAM | 1 in 1 CARTON | SOLUTION | 1 | | 5 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 70748-411-01 | 70748041101 | 1 BOTTLE in 1 CARTON (70748-411-01) / 300 mL in 1 BOTTLE | 1 bottle | 2026-02-23 | No | No | Current |