Prescription drug · ANDA
Brivaracetam NDC 0121-1074
Brivaracetam 10 mg/mL · Solution · Oral · PAI Holdings, LLC dba PAI Pharma
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0121-1074-10 | 00121107410 | 1 BOTTLE in 1 CARTON (0121-1074-10) / 300 mL in 1 BOTTLEMarketed from Feb 23, 2026 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 — 10 mg/mL
- Dosage form
- Solution
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 218494
- Marketing start
- Listing expires
- DEA schedule
- CV
- Other FDA classes
- Epoxide Hydrolase Inhibitors (Mechanism)
- Identifiers
- Product ID 0121-1074_6e474aba-29da-4afb-801c-000ca4393f74SPL ID 6e474aba-29da-4afb-801c-000ca4393f74SPL set ID 57627ea9-3b14-4428-ad95-6ea25ecaef31RxCUI 1739785UNII 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
N400121107410followed by a unit qualifier and the quantityPackage 00121-1074-10. 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 oral solution is indicated for the treatment of partial-onset seizures in patients 1 month of age and older. Brivaracetam oral solution 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 218494
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 10 mg/mL | SolutionOral | Zhejiang Poly Pharm. Co., Ltd. | 72673-031 |
- openFDA data updated
Med-Code stores this record for up to 24 hours before requesting it again.
Reference information only. Verify codes and billing rules against the applicable payer and official source before submitting a claim. How Med-Code handles data.