Prescription drug · ANDA
Levetiracetam NDC 70010-524
Levetiracetam 1000 mg/1 · Tablet, Film coated · Oral · Granules Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70010-524-03 | 70010052403 | 30 TABLET, FILM COATED in 1 BOTTLE (70010-524-03)Marketed from Jun 24, 2024 | |
| 70010-524-10 | 70010052410 | 1000 TABLET, FILM COATED in 1 BOTTLE (70010-524-10)Marketed from Jun 24, 2024 |
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 — 1000 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 217878
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
- Identifiers
- Product ID 70010-524_451c385c-1c8a-5eca-e063-6294a90a3a4fSPL ID 451c385c-1c8a-5eca-e063-6294a90a3a4fSPL set ID b4781ec4-43ad-4052-9a6a-b24fda119b32RxCUI 311288, 311289, 311290, 387003UNII 44YRR34555UPC 0370010524033, 0370010521032, 0370010522039
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
N470010052403followed by a unit qualifier and the quantityPackage 70010-0524-03. 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 o…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 217878
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 | Granules Pharmaceuticals Inc. | 70010-523 |
| Levetiracetam | Levetiracetam 250 mg/1 | Tablet, Film coatedOral | Granules Pharmaceuticals Inc. | 70010-521 |
| Levetiracetam | Levetiracetam 500 mg/1 | Tablet, Film coatedOral | Granules Pharmaceuticals Inc. | 70010-522 |