Prescription drug · NDA
Keppra (Levetiracetam) NDC 50474-595
Levetiracetam 500 mg/1 · Tablet, Film coated · Oral · UCB, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50474-595-40 | 50474059540 | 120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50474-595-40)Marketed from Apr 24, 2000 |
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)
- Keppra
- Generic name (nonproprietary)
- levetiracetam
- Active ingredients
- Levetiracetam — 500 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- UCB, Inc.NDC labeler code 50474
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 021035
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
- Identifiers
- Product ID 50474-595_4974b225-87ca-610e-e063-6294a90ad20aSPL ID 4974b225-87ca-610e-e063-6294a90ad20aSPL set ID 3ca9df05-a506-4ec8-a4fe-320f1219ab21RxCUI 261335, 261336, 284391, 311288, 311289, 311290, 387003, 403884, 404595, 630807UNII 44YRR34555UPC 0350474595404
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
N450474059540followed by a unit qualifier and the quantityPackage 50474-0595-40. 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)
KEPPRA is indicated for the treatment of partial-onset seizures in patients 1 month of age and older ( 1.1 ) KEPPRA 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 KEPPRA is 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 KEPPRA is indicated as adjunctive therapy for the treatment of myoclonic seizures in patients 12 years of a…
Excerpt only. Read the full label for complete information.
About NDC 50474-595
- What is NDC 50474-595?
- 50474-595 is the product NDC for Keppra (levetiracetam), Levetiracetam 500 mg/1 tablet, film coated, listed with the FDA by UCB, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Keppra (Levetiracetam).
- What is the active ingredient?
- Levetiracetam.
- Who is the labeler?
- UCB, Inc., NDC labeler code 50474. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Keppra?
- 5 other product NDCs are listed under this name. See all Keppra NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Keppra products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Keppralevetiracetam | Levetiracetam 100 mg/mL | Injection, Solution, ConcentrateIntravenous | UCB, Inc. | 50474-002 | 50474-0002-63 |
| Keppralevetiracetam | Levetiracetam 100 mg/mL | SolutionOral | UCB, Inc. | 50474-001 | 50474-0001-48 |
| Keppralevetiracetam | Levetiracetam 250 mg/1 | Tablet, Film coatedOral | UCB, Inc. | 50474-594 | 50474-0594-40 |
| Keppralevetiracetam | Levetiracetam 750 mg/1 | Tablet, Film coatedOral | UCB, Inc. | 50474-596 | 50474-0596-40 |
| Keppralevetiracetam | Levetiracetam 1000 mg/1 | Tablet, Film coatedOral | UCB, Inc. | 50474-597 | 50474-0597-66 |
Other NDCs under NDA 021035
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 |
|---|---|---|---|---|
| Keppralevetiracetam | Levetiracetam 250 mg/1 | Tablet, Film coatedOral | UCB, Inc. | 50474-594 |
| Keppralevetiracetam | Levetiracetam 750 mg/1 | Tablet, Film coatedOral | UCB, Inc. | 50474-596 |
| Keppralevetiracetam | Levetiracetam 1000 mg/1 | Tablet, Film coatedOral | UCB, Inc. | 50474-597 |