Prescription drug · NDA
Briviact (Brivaracetam) NDC 50474-370
Brivaracetam 10 mg/1 · Tablet, Film coated · Oral · UCB, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50474-370-66 | 50474037066 | 1 BOTTLE in 1 CARTON (50474-370-66) / 60 TABLET, FILM COATED in 1 BOTTLEMarketed from May 12, 2016 |
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)
- Briviact
- Generic name (nonproprietary)
- brivaracetam
- Active ingredients
- Brivaracetam — 10 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- UCB, Inc.NDC labeler code 50474
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 205836
- Marketing start
- Listing expires
- DEA schedule
- CV
- Other FDA classes
- Epoxide Hydrolase Inhibitors (Mechanism)
- Identifiers
- Product ID 50474-370_597ca2bd-7caa-0d00-e063-6394a90a00c7SPL ID 597ca2bd-7caa-0d00-e063-6394a90a00c7SPL set ID 3cf2f439-0e97-443e-8e33-25ecef616f6cRxCUI 1739749, 1739754, 1739761, 1739766, 1739768, 1739770, 1739772, 1739774, 1739776, 1739778, 1739780, 1739782, 1739785, 1739788UNII U863JGG2IA
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
N450474037066followed by a unit qualifier and the quantityPackage 50474-0370-66. 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)
BRIVIACT is indicated for the treatment of partial-onset seizures in patients 1 month of age and older. BRIVIACT 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.
About NDC 50474-370
- What is NDC 50474-370?
- 50474-370 is the product NDC for Briviact (brivaracetam), Brivaracetam 10 mg/1 tablet, film coated, listed with the FDA by UCB, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Briviact (Brivaracetam).
- What is the active ingredient?
- Brivaracetam.
- Who is the labeler?
- UCB, Inc., NDC labeler code 50474. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Briviact?
- 6 other product NDCs are listed under this name. See all Briviact NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Briviact products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Briviactbrivaracetam | Brivaracetam 25 mg/1 | Tablet, Film coatedOral | UCB, Inc. | 50474-470 | 50474-0470-0950474-0470-1450474-0470-66 |
| Briviactbrivaracetam | Brivaracetam 50 mg/1 | Tablet, Film coatedOral | UCB, Inc. | 50474-570 | 50474-0570-0950474-0570-1450474-0570-66 |
| Briviactbrivaracetam | Brivaracetam 75 mg/1 | Tablet, Film coatedOral | UCB, Inc. | 50474-670 | 50474-0670-66 |
| Briviactbrivaracetam | Brivaracetam 100 mg/1 | Tablet, Film coatedOral | UCB, Inc. | 50474-770 | 50474-0770-0950474-0770-1450474-0770-66 |
| Briviactbrivaracetam | Brivaracetam 10 mg/mL | SolutionOral | UCB, Inc. | 50474-870 | 50474-0870-15 |
| Briviactbrivaracetam | Brivaracetam 50 mg/5mL | Injection, SuspensionIntravenous | UCB, Inc. | 50474-970 | 50474-0970-75 |
Other NDCs under NDA 205836
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 |
|---|---|---|---|---|
| Briviactbrivaracetam | Brivaracetam 25 mg/1 | Tablet, Film coatedOral | UCB, Inc. | 50474-470 |
| Briviactbrivaracetam | Brivaracetam 50 mg/1 | Tablet, Film coatedOral | UCB, Inc. | 50474-570 |
| Briviactbrivaracetam | Brivaracetam 75 mg/1 | Tablet, Film coatedOral | UCB, Inc. | 50474-670 |
| Briviactbrivaracetam | Brivaracetam 100 mg/1 | Tablet, Film coatedOral | UCB, Inc. | 50474-770 |