Prescription drug · ANDA
Brivaracetam (Brivaracetam injection) NDC 0121-1075
Brivaracetam 50 mg/5mL · Injection · Intravenous · PAI Holdings, LLC dba PAI Pharma
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0121-1075-02 | 00121107502 | 10 VIAL, GLASS in 1 CARTON (0121-1075-02) / 5 mL in 1 VIAL, GLASS (0121-1075-55)Marketed 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 injection
- Active ingredients
- Brivaracetam — 50 mg/5mL
- Dosage form
- Injection
- Route
- Intravenous
- Labeler
- PAI Holdings, LLC dba PAI PharmaNDC labeler code 0121
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 218249
- Marketing start
- Listing expires
- DEA schedule
- CV
- Other FDA classes
- Epoxide Hydrolase Inhibitors (Mechanism)
- Identifiers
- Product ID 0121-1075_c0702161-ae73-4aac-b6fd-fb3fa7c841b8SPL ID c0702161-ae73-4aac-b6fd-fb3fa7c841b8SPL set ID 5bc0f4c0-8b31-4622-849f-d902be93788bRxCUI 1739749UNII U863JGG2IAUPC 0301211075550
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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N400121107502followed by a unit qualifier and the quantityPackage 00121-1075-02. 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.
About NDC 0121-1075
- What is NDC 0121-1075?
- 0121-1075 is the product NDC for Brivaracetam (brivaracetam injection), Brivaracetam 50 mg/5mL injection, listed with the FDA by PAI Holdings, LLC dba PAI Pharma. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Brivaracetam (Brivaracetam Injection).
- What is the active ingredient?
- Brivaracetam.
- Who is the labeler?
- PAI Holdings, LLC dba PAI Pharma, NDC labeler code 0121. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Brivaracetam?
- 52 other product NDCs are listed under this name. See all Brivaracetam NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Brivaracetam products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Brivaracetam | Brivaracetam 10 mg/mL | SolutionOral | Aurobindo Pharma Limited | 59651-995 | 59651-0995-03 |
| Brivaracetam | Brivaracetam 10 mg/1 | Tablet, Film coatedOral | Exelan Pharmaceuticals, Inc | 76282-822 | 76282-0822-60 |
| Brivaracetam | Brivaracetam 25 mg/1 | Tablet, Film coatedOral | Exelan Pharmaceuticals, Inc | 76282-823 | 76282-0823-60 |
| Brivaracetam | Brivaracetam 50 mg/1 | Tablet, Film coatedOral | Exelan Pharmaceuticals, Inc | 76282-824 | 76282-0824-60 |
| Brivaracetam | Brivaracetam 75 mg/1 | Tablet, Film coatedOral | Exelan Pharmaceuticals, Inc | 76282-825 | 76282-0825-60 |
| Brivaracetam | Brivaracetam 100 mg/1 | Tablet, Film coatedOral | Exelan Pharmaceuticals, Inc | 76282-826 | 76282-0826-60 |
| Brivaracetam | Brivaracetam 10 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 84386-068 | 84386-0068-60 |
| Brivaracetam | Brivaracetam 25 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 84386-069 | 84386-0069-60 |
| Brivaracetam | Brivaracetam 75 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 84386-071 | 84386-0071-60 |
| brivaracetam | Brivaracetam 25 mg/1 | Tablet, Film coatedOral | AvKARE | 73190-074 | 73190-0074-60 |
Other NDCs under ANDA 218249
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 50 mg/5mL | InjectionIntravenous | Hainan Poly Pharm. Co., Ltd. | 14335-420 |