Prescription drug · ANDA
Levetiracetam in Sodium Chloride (levetiracetam) NDC 14789-220
Levetiracetam 10 mg/mL · Injection · Intravenous · Nexus Pharmaceuticals LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 14789-220-10 | 14789022010 | 10 BAG in 1 CARTON (14789-220-10) / 100 mL in 1 BAG (14789-220-08)Marketed from Jul 20, 2020 |
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)
- Levetiracetam in Sodium Chloride
- Generic name (nonproprietary)
- levetiracetam
- Active ingredients
- Levetiracetam — 10 mg/mL
- Dosage form
- Injection
- Route
- Intravenous
- Labeler
- Nexus Pharmaceuticals LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 213532
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
- Identifiers
- Product ID 14789-220_a8f5d5d3-7659-4b56-895c-d1f9c3e81973SPL ID a8f5d5d3-7659-4b56-895c-d1f9c3e81973SPL set ID ee014183-a857-457b-9573-0cc168e560f3RxCUI 1193358, 1193360, 1193362UNII 44YRR34555UPC 0314789330150, 0314789110080, 0314789330082, 0314789220086
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
N414789022010followed by a unit qualifier and the quantityPackage 14789-0220-10. 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)
Levetiracetam in Sodium Chloride Injection is indicated for adjunct therapy in adults (≥16 years of age) with the following seizure types when oral administration is temporarily not feasible: Partial-onset seizures ( 1.1 ) Myoclonic seizures in patients with juvenile myoclonic epilepsy ( 1.2 ) Primary generalized tonic-clonic seizures ( 1.3 ) 1.1 Partial-Onset Seizures Levetiracetam in Sodium Chloride Injection is indicated as adjunctive therapy in the treatment of partial-onset seizures in adults with epilepsy. 1.2 Myoclonic Seizures in Patients with Juvenile Myoclonic Epilepsy Levetiracetam in Sodium Chloride Injection is indicated as adjunctive therapy in the treatment of myoclonic seizur…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 213532
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 |
|---|---|---|---|---|
| Levetiracetam in Sodium Chloridelevetiracetam | Levetiracetam 5 mg/mL | InjectionIntravenous | Nexus Pharmaceuticals LLC | 14789-110 |
| Levetiracetam in Sodium Chloridelevetiracetam | Levetiracetam 15 mg/mL | InjectionIntravenous | Nexus Pharmaceuticals LLC | 14789-330 |