Prescription drug · ANDA
Levetiracetam NDC 48433-052
Levetiracetam 500 mg/1 · Tablet, Film coated · Oral · Safecor Health LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 48433-052-20 | 48433005220 | 100 BLISTER PACK in 1 CARTON (48433-052-20) / 1 TABLET, FILM COATED in 1 BLISTER PACK (48433-052-01)Marketed from Mar 18, 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
- Safecor Health LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076919
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
- Identifiers
- Product ID 48433-052_4f0c308f-3ef4-05f9-e063-6394a90ab87bSPL ID 4f0c308f-3ef4-05f9-e063-6394a90ab87bSPL set ID e72a7410-13fd-40e4-befb-052d0455e038RxCUI 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
N448433005220followed by a unit qualifier and the quantityPackage 48433-0052-20. 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.
Other NDCs under ANDA 076919
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 500 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-5699 |
| Levetiracetam | Levetiracetam 500 mg/1 | Tablet, Film coatedOral | Mylan Institutional Inc. | 51079-821 |
| Levetiracetam | Levetiracetam 500 mg/1 | Tablet, Film coatedOral | Mylan Pharmaceuticals Inc. | 0378-5615 |
| Levetiracetam | Levetiracetam 750 mg/1 | Tablet, Film coatedOral | Mylan Pharmaceuticals Inc. | 0378-5617 |
| Levetiracetam | Levetiracetam 500 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-0288 |