Prescription drug · ANDA
Levetiracetam NDC 13668-015
Levetiracetam 500 mg/1 · Tablet · Oral · Torrent Pharmaceuticals Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 13668-015-05 | 13668001505 | 500 TABLET in 1 BOTTLE (13668-015-05)Marketed from Jan 15, 2009 | |
| 13668-015-12 | 13668001512 | 120 TABLET in 1 BOTTLE (13668-015-12)Marketed from Jan 15, 2009 | |
| 13668-015-17 | 13668001517 | 1350 TABLET in 1 BOTTLE (13668-015-17)Marketed from Jan 15, 2009 | |
| 13668-015-25 | 13668001525 | 250 TABLET in 1 BOTTLE (13668-015-25)Marketed from Jan 15, 2009 | |
| 13668-015-60 | 13668001560 | 60 TABLET in 1 BOTTLE (13668-015-60)Marketed from Jan 15, 2009 |
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
- 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 13668-015_b8792837-f86a-4e67-b1a5-ec8ca278fe77SPL ID b8792837-f86a-4e67-b1a5-ec8ca278fe77SPL set ID 6ab24168-058d-496e-9023-da8ee6353eb3RxCUI 311288, 311289, 311290, 387003UNII 44YRR34555UPC 0313668017601, 0313668016604, 0313668014600, 0313668015607
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
N413668001505followed by a unit qualifier and the quantityPackage 13668-0015-05. 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
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 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 | OWP Pharmaceuticals, Inc. | 69102-105 |
| 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 |