Prescription drug · ANDA
Levetiracetam NDC 69102-105
Levetiracetam 500 mg/1 · Tablet · Oral · OWP Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69102-105-01 | 69102010501 | 120 TABLET in 1 BOTTLE (69102-105-01)Marketed from Oct 28, 2020 |
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
- Route
- Oral
- Labeler
- OWP Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078858
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
- Identifiers
- Product ID 69102-105_c7262ce0-c186-487b-9808-b340d31d8fe4SPL ID c7262ce0-c186-487b-9808-b340d31d8fe4SPL set ID e662bf5b-c81c-4bcd-ba2e-552df95ca6f9RxCUI 311288, 311289, 311290, 387003, 1875868UNII 44YRR34555UPC 0369102107018, 0369102106011
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
N469102010501followed by a unit qualifier and the quantityPackage 69102-0105-01. 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.
Other NDCs under ANDA 078858
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 | TabletOral | OWP Pharmaceuticals, Inc. | 69102-106 |
| Levetiracetam | Levetiracetam 500 mg/1 | TabletOral | Torrent Pharmaceuticals Limited | 13668-015 |
| Levetiracetam | Levetiracetam 1000 mg/1 | TabletOral | OWP Pharmaceuticals, Inc. | 69102-107 |
| Levetiracetam | Levetiracetam 250 mg/1 | TabletOral | Torrent Pharmaceuticals Limited | 13668-014 |
| Roweepralevetiracetam | Levetiracetam 250 mg/1 | TabletOral | OWP Pharmaceuticals, Inc. | 69102-108 |
| Levetiracetam | Levetiracetam 750 mg/1 | TabletOral | Torrent Pharmaceuticals Limited | 13668-016 |
| Levetiracetam | Levetiracetam 1000 mg/1 | TabletOral | Torrent Pharmaceuticals Limited | 13668-017 |
| Levetiracetam | Levetiracetam 500 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 43063-499 |
| Levetiracetam | Levetiracetam 500 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2282 |