Brivaracetam
- Product NDC
- 0121-1075
- 11-digit product format
- 001211075
- Labeler code
- 0121
- Product ID
- 0121-1075_c0702161-ae73-4aac-b6fd-fb3fa7c841b8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Brivaracetam Injection
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- PAI Holdings, LLC dba PAI Pharma
- Application
- ANDA218249
- Marketing category
- ANDA
- Marketing start
- 2026-02-23
- 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 |
|---|
| 0121-1075-02 | Brivaracetam | 10 in 1 CARTON | INJECTION | 10 | | 3 |
| 0121-1075-55 | Brivaracetam | 5 mL in 1 VIAL, GLASS | INJECTION | 5 | | 3 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 0121-1075-02 | 00121107502 | 10 VIAL, GLASS in 1 CARTON (0121-1075-02) / 5 mL in 1 VIAL, GLASS (0121-1075-55) | | 2026-02-23 | No | No | Current |
| 0121-1075-55 | 00121107555 | 5 mL in 1 VIAL, GLASS | 5 ml | | | | Historical |