Prescription drug · ANDA
Levetiracetam NDC 69339-157
Levetiracetam 100 mg/mL · Solution · Oral · Natco Pharma USA LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69339-157-17 | 69339015717 | 40 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (69339-157-17) / 5 mL in 1 CUP, UNIT-DOSE (69339-157-05)Marketed from Jan 31, 2021 | |
| 69339-157-19 | 69339015719 | 100 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (69339-157-19) / 5 mL in 1 CUP, UNIT-DOSE (69339-157-05)Marketed from Jan 31, 2021 |
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 — 100 mg/mL
- Dosage form
- Solution
- Route
- Oral
- Labeler
- Natco Pharma USA LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 203052
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
- Identifiers
- Product ID 69339-157_2ec94a03-8590-4617-a6e6-782e0aae7037SPL ID 2ec94a03-8590-4617-a6e6-782e0aae7037SPL set ID 34af3602-0188-4d2e-904b-2e40000bb45cRxCUI 403884UNII 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
N469339015717followed by a unit qualifier and the quantityPackage 69339-0157-17. 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 oral solution is indicated for the treatment of partial-onset seizures in patients 1 month of age and older ( 1.1 ) Levetiracetam oral solution 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 oral solution is 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 oral solution is indicated as …
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 203052
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 |
|---|---|---|---|---|
| Levetiracetamlevetiracetam oral | Levetiracetam 100 mg/mL | SolutionOral | Camber Pharmaceuticals, Inc. | 31722-574 |
| Levetiracetam | Levetiracetam 100 mg/mL | SolutionOral | American Health Packaging | 60687-249 |
| Levetiracetam Levetiracetamlevetiracetam | Levetiracetam 100 mg/mL | SolutionOral | Atlantic Biologicals Corp. | 17856-0574 |