Brivaracetam
- Product NDC
- 60505-4724
- 11-digit product format
- 605054724
- Labeler code
- 60505
- Product ID
- 60505-4724_a2119162-90a5-0d0c-9d3b-6364bf087960
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Brivaracetam
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Apotex Corp.
- Application
- ANDA214875
- Marketing category
- ANDA
- Marketing start
- 2026-02-24
- Substance
- BRIVARACETAM
- Active strength
- 25 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 |
|---|---|
| BRIVARACETAM | 25 mg/1 |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | U863JGG2IA |
| Rxcui | 1739761, 1739768, 1739772, 1739776, 1739780 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 362d7abb-94e6-4c60-9a58-266894157713 | Product name | 1 | 20231023 |
| 594e2c86-3079-4e6e-96c9-48f7a8afc78d | Product name | 1 | 20230718 |
| 816b97af-edc5-4060-aff1-b814bdbcad50 | Product name | 1 | 20190415 |
| 419aab54-5d5a-4146-9453-026d4a9991be | Product name | 2 | 20170525 |
| 1447c696-6954-40c0-b275-6f6c780ca8b7 | Product name | 1 | 20160323 |
| 89dac932-b90a-4410-9ab1-84c53e57de25 | Product name | 1 | 20150316 |
| d723478e-ad4a-ec23-6bd7-cfe33e1e3840 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 60505-4724-6 | Brivaracetam | 60 in 1 BOTTLE | TABLET | 60 | 2 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 60505-4724-6 | EA - Each | 60505-4724 | 3b3ffd64-1228-4791-9a8e-e978303474f2 | 1 | 2026-03-17 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1739761 | brivaracetam 10 MG Oral Tablet | PSN | 1915620d-4f37-56c2-437e-8362bb462d07 | 2 |
| 1739768 | brivaracetam 100 MG Oral Tablet | PSN | 1915620d-4f37-56c2-437e-8362bb462d07 | 2 |
| 1739772 | brivaracetam 25 MG Oral Tablet | PSN | 1915620d-4f37-56c2-437e-8362bb462d07 | 2 |
| 1739776 | brivaracetam 50 MG Oral Tablet | PSN | 1915620d-4f37-56c2-437e-8362bb462d07 | 2 |
| 1739780 | brivaracetam 75 MG Oral Tablet | PSN | 1915620d-4f37-56c2-437e-8362bb462d07 | 2 |
| 1739761 | brivaracetam 10 MG Oral Tablet | SCD | 1915620d-4f37-56c2-437e-8362bb462d07 | 2 |
| 1739768 | brivaracetam 100 MG Oral Tablet | SCD | 1915620d-4f37-56c2-437e-8362bb462d07 | 2 |
| 1739772 | brivaracetam 25 MG Oral Tablet | SCD | 1915620d-4f37-56c2-437e-8362bb462d07 | 2 |
| 1739776 | brivaracetam 50 MG Oral Tablet | SCD | 1915620d-4f37-56c2-437e-8362bb462d07 | 2 |
| 1739780 | brivaracetam 75 MG Oral Tablet | SCD | 1915620d-4f37-56c2-437e-8362bb462d07 | 2 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 60505-4724-6 | 60505472406 | 60 TABLET in 1 BOTTLE (60505-4724-6) | 60 tablet | 2026-02-24 | No | No | Current |