Brivaracetam
- Product NDC
- 14335-420
- 11-digit product format
- 143350420
- Labeler code
- 14335
- Product ID
- 14335-420_4a887373-339e-1795-e063-6394a90a17dc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- brivaracetam
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Hainan Poly Pharm. Co., Ltd.
- Application
- ANDA218249
- Marketing category
- ANDA
- Marketing start
- 2026-02-21
- 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 |
|---|
| 14335-420-01 | Brivaracetam | 5 mL in 1 VIAL, GLASS | INJECTION | 5 | | 1 |
| 14335-420-10 | Brivaracetam | 10 in 1 CARTON | INJECTION | 10 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 14335-420-01 | 14335042001 | 5 mL in 1 VIAL, GLASS | 5 ml | | | | Historical |
| 14335-420-10 | 14335042010 | 10 VIAL, GLASS in 1 CARTON (14335-420-10) / 5 mL in 1 VIAL, GLASS (14335-420-01) | | 2026-02-21 | No | No | Historical |