Prescription drug · ANDA
Levetiracetam NDC 16714-034
Levetiracetam 250 mg/1 · Tablet, Film coated · Oral · NorthStar RxLLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 16714-034-01 | 16714003401 | 120 TABLET, FILM COATED in 1 BOTTLE (16714-034-01)Marketed from Mar 29, 2022 | |
| 16714-034-02 | 16714003402 | 500 TABLET, FILM COATED in 1 BOTTLE (16714-034-02)Marketed from Mar 29, 2022 |
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 — 250 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- NorthStar RxLLC
- 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 16714-034_40911071-2280-bd37-e063-6394a90a0156SPL ID 40911071-2280-bd37-e063-6394a90a0156SPL set ID 3884cb76-822b-400d-9b24-49c286c9b6f7RxCUI 311288, 311289, 311290, 387003UNII 44YRR34555UPC 0316714034010, 0316714035024, 0316714034027, 0316714537016, 0316714310015, 0316714035017, 0316714537023
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
N416714003401followed by a unit qualifier and the quantityPackage 16714-0034-01. 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
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Levetiracetam tablets are indicated for the treatment of partial-onset seizures in patients 1 month of age and older ( 1.1 ) Levetiracetam tablets are 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 thera…
Excerpt only. Read the full label for complete information.
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 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 750 mg/1 | Tablet, Film coatedOral | Quallent Pharmaceuticals Health LLC | 82009-123 |
| 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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