Prescription drug · ANDA
brivaracetam NDC 50228-560
Brivaracetam 100 mg/1 · Tablet, Film coated · Oral · ScieGen Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50228-560-10 | 50228056010 | 1000 TABLET, FILM COATED in 1 BOTTLE (50228-560-10)Marketed from Mar 27, 2026 | |
| 50228-560-30 | 50228056030 | 30 TABLET, FILM COATED in 1 BOTTLE (50228-560-30)Marketed from Mar 27, 2026 | |
| 50228-560-60 | 50228056060 | 60 TABLET, FILM COATED in 1 BOTTLE (50228-560-60)Marketed from Mar 27, 2026 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- brivaracetam
- Generic name (nonproprietary)
- brivaracetam
- Active ingredients
- Brivaracetam — 100 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 219952
- Marketing start
- Listing expires
- DEA schedule
- CV
- Other FDA classes
- Epoxide Hydrolase Inhibitors (Mechanism)
- Identifiers
- Product ID 50228-560_193abd80-412f-44b3-8dc7-1c47011c58b6SPL ID 193abd80-412f-44b3-8dc7-1c47011c58b6SPL set ID bdbb6756-654c-46f1-a85c-7d5d1a89685aRxCUI 1739761, 1739768, 1739772, 1739776, 1739780UNII U863JGG2IAUPC 0350228558105, 0350228560603, 0350228560306, 0350228558600, 0350228559300, 0350228557306, 0350228560108, 0350228556101, 0350228556606, 0350228556309, 0350228558303, 0350228559607, 0350228559102, 0350228557108
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N450228056010followed by a unit qualifier and the quantityPackage 50228-0560-10. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Brivaracetam is indicated for the treatment of partial-onset seizures in patients 1 month of age and older. Brivaracetam is indicated for the treatment of partial-onset seizures in patients 1 month of age and older. ( 1 )
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 219952
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Brivaracetam | Brivaracetam 25 mg/1 | Tablet, Film coatedOral | Exelan Pharmaceuticals, Inc | 76282-823 |
| brivaracetam | Brivaracetam 50 mg/1 | Tablet, Film coatedOral | ScieGen Pharmaceuticals, Inc. | 50228-558 |
| brivaracetam | Brivaracetam 10 mg/1 | Tablet, Film coatedOral | ScieGen Pharmaceuticals, Inc. | 50228-556 |
| Brivaracetam | Brivaracetam 10 mg/1 | Tablet, Film coatedOral | Exelan Pharmaceuticals, Inc | 76282-822 |
| brivaracetam | Brivaracetam 25 mg/1 | Tablet, Film coatedOral | ScieGen Pharmaceuticals, Inc. | 50228-557 |
| Brivaracetam | Brivaracetam 75 mg/1 | Tablet, Film coatedOral | Exelan Pharmaceuticals, Inc | 76282-825 |
| Brivaracetam | Brivaracetam 50 mg/1 | Tablet, Film coatedOral | Exelan Pharmaceuticals, Inc | 76282-824 |
| brivaracetam | Brivaracetam 75 mg/1 | Tablet, Film coatedOral | ScieGen Pharmaceuticals, Inc. | 50228-559 |
| Brivaracetam | Brivaracetam 100 mg/1 | Tablet, Film coatedOral | Exelan Pharmaceuticals, Inc | 76282-826 |