Prescription drug · ANDA
Levetiracetam NDC 82009-123
Levetiracetam 750 mg/1 · Tablet, Film coated · Oral · Quallent Pharmaceuticals Health LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 82009-123-05 | 82009012305 | 500 TABLET, FILM COATED in 1 BOTTLE (82009-123-05)Marketed from Jul 19, 2023 |
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 — 750 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090515
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
- Identifiers
- Product ID 82009-123_4090ba40-7f20-ea57-e063-6294a90acaa8SPL ID 4090ba40-7f20-ea57-e063-6294a90acaa8SPL set ID 3756f052-919c-4817-a56e-1091fd514d9dRxCUI 311288, 311289, 311290, 387003UNII 44YRR34555UPC 0382009121055, 0382009123059, 0382009124605, 0382009122052
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
N482009012305followed by a unit qualifier and the quantityPackage 82009-0123-05. 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 090515
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 250 mg/1 | Tablet, Film coatedOral | NorthStar RxLLC | 16714-034 |
| Levetiracetam | Levetiracetam 500 mg/1 | Tablet, Film coatedOral | NorthStar RxLLC | 16714-035 |
| Levetiracetam | Levetiracetam 500 mg/1 | Tablet, Film coatedOral | Injecta Medcial LLC | 87234-0035 |
| Levetiracetam | Levetiracetam 250 mg/1 | Tablet, Film coatedOral | Quallent Pharmaceuticals Health LLC | 82009-121 |
| Levetiracetam | Levetiracetam 500 mg/1 | Tablet, Film coatedOral | Quallent Pharmaceuticals Health LLC | 82009-122 |
| Levetiracetam | Levetiracetam 1000 mg/1 | Tablet, Film coatedOral | Quallent Pharmaceuticals Health LLC | 82009-124 |
| Levetiracetam | Levetiracetam 250 mg/1 | Tablet, Film coatedOral | Camber Pharmaceuticals, Inc. | 31722-536 |
| Levetiracetam | Levetiracetam 500 mg/1 | Tablet, Film coatedOral | Camber Pharmaceuticals, Inc. | 31722-537 |
| Levetiracetam | Levetiracetam 750 mg/1 | Tablet, Film coatedOral | Camber Pharmaceuticals, Inc. | 31722-538 |
| Levetiracetam | Levetiracetam 1000 mg/1 | Tablet, Film coatedOral | Camber Pharmaceuticals, Inc. | 31722-539 |
| Levetiracetam | Levetiracetam 250 mg/1 | Tablet, Film coatedOral | DIRECT RX | 72189-190 |
| Levetiracetam | Levetiracetam 1000 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-6086 |
| Levetiracetam | Levetiracetam 500 mg/1 | Tablet, Film coatedOral | DIRECT RX | 72189-229 |
| Levetiracetam | Levetiracetam 1000 mg/1 | Tablet, Film coatedOral | NorthStar RxLLC | 16714-310 |
| Levetiracetam | Levetiracetam 500 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 72789-152 |
| Levetiracetam | Levetiracetam 250 mg/1 | Tablet, Film coatedOral | XLCare Pharmaceuticals Inc. | 72865-187 |
| Levetiracetam | Levetiracetam 1000 mg/1 | Tablet, Film coatedOral | XLCare Pharmaceuticals Inc. | 72865-190 |
| Levetiracetam | Levetiracetam 500 mg/1 | Tablet, Film coatedOral | XLCare Pharmaceuticals Inc. | 72865-188 |
| Levetiracetam | Levetiracetam 750 mg/1 | Tablet, Film coatedOral | XLCare Pharmaceuticals Inc. | 72865-189 |
| Levetiracetam | Levetiracetam 500 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-0694 |
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