Prescription drug · ANDA
Brivaracetam NDC 14335-420
Brivaracetam 50 mg/5mL · Injection · Intravenous · Hainan Poly Pharm. Co., Ltd.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 14335-420-10 | 14335042010 | 10 VIAL, GLASS in 1 CARTON (14335-420-10) / 5 mL in 1 VIAL, GLASS (14335-420-01)Marketed from Feb 21, 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 — 50 mg/5mL
- Dosage form
- Injection
- Route
- Intravenous
- Labeler
- Hainan Poly Pharm. Co., Ltd.
- 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 14335-420_4a887373-339e-1795-e063-6394a90a17dcSPL ID 4a887373-339e-1795-e063-6394a90a17dcSPL set ID 3ea51292-fe03-46f5-9d9b-36986f5b7224RxCUI 1739749UNII U863JGG2IAUPC 0314335420106
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
N414335042010followed by a unit qualifier and the quantityPackage 14335-0420-10. 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 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 |
|---|---|---|---|---|
| Brivaracetambrivaracetam injection | Brivaracetam 50 mg/5mL | InjectionIntravenous | PAI Holdings, LLC dba PAI Pharma | 0121-1075 |
- openFDA data updated
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