Prescription drug · ANDA
Levetiracetam NDC 87441-046
Levetiracetam 500 mg/1 · Tablet, Film coated · Oral · Unit Dose Solutions, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 87441-046-01 | 87441004601 | 30 TABLET, FILM COATED in 1 BLISTER PACK (87441-046-01)Marketed from Jun 25, 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)
- Levetiracetam
- Generic name (nonproprietary)
- levetiracetam
- Active ingredients
- Levetiracetam — 500 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Unit Dose Solutions, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078993
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
- Identifiers
- Product ID 87441-046_55161f59-228b-e452-e063-6294a90a5191SPL ID 55161f59-228b-e452-e063-6294a90a5191SPL set ID 551626eb-3282-e439-e063-6294a90a8314RxCUI 311289UNII 44YRR34555
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
N487441004601followed by a unit qualifier and the quantityPackage 87441-0046-01. 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 is indicated for the treatment of partial-onset seizures in patients 1 month of age and older ( 1.1 ) Levetiracetam is indicated for adjunctive therapy for the treatment of: Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy (1.2) Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy (1.3) 1.1 Partial-Onset Seizures Levetiracetam tablets are indicated for the treatment of partial-onset seizures in patients 1 month of age and older. 1.2 Myoclonic Seizures in Patients with Juvenile Myoclonic Epilepsy Levetiracetam tablets are indicated as adjunctive therapy for the treatment of my…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 078993
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 | Levetiracetam 750 mg/1 | Tablet, Film coatedOral | BluePoint Laboratories | 68001-404 |
| Levetiracetam | Levetiracetam 250 mg/1 | Tablet, Film coatedOral | BluePoint Laboratories | 68001-402 |
| Levetiracetam | Levetiracetam 500 mg/1 | Tablet, Film coatedOral | BluePoint Laboratories | 68001-403 |
| Levetiracetam | Levetiracetam 1000 mg/1 | Tablet, Film coatedOral | BluePoint Laboratories | 68001-405 |
| Levetiracetam | Levetiracetam 500 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-3367 |
| Levetiracetam | Levetiracetam 250 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 65862-245 |
| Levetiracetam | Levetiracetam 500 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-0420 |
| Levetiracetam | Levetiracetam 500 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 65862-246 |
| Levetiracetam | Levetiracetam 750 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 65862-247 |
| Levetiracetam | Levetiracetam 250 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-4171 |
| Levetiracetam | Levetiracetam 1000 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 65862-315 |
| Levetiracetam | Levetiracetam 250 mg/1 | Tablet, Film coatedOral | Major Pharmaceuticals | 0904-7123 |
| Levetiracetam | Levetiracetam 500 mg/1 | Tablet, Film coatedOral | Major Pharmaceuticals | 0904-7124 |
| Levetiracetam | Levetiracetam 750 mg/1 | Tablet, Film coatedOral | Major Pharmaceuticals | 0904-7125 |
| Levetiracetam | Levetiracetam 500 mg/1 | Tablet, Film coatedOral | American Health Packaging | 60687-657 |
| Levetiracetam | Levetiracetam 1000 mg/1 | Tablet, Film coatedOral | American Health Packaging | 60687-668 |
| Levetiracetam | Levetiracetam 250 mg/1 | Tablet, Film coatedOral | American Health Packaging | 68084-859 |
| Levetiracetam | Levetiracetam 750 mg/1 | Tablet, Film coatedOral | American Health Packaging | 68084-882 |
| Levetiracetam | Levetiracetam 1000 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-0863 |
| Levetiracetam | Levetiracetam 500 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7768 |
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