Prescription drug · NDA
Keppra XR (Levetiracetam) NDC 50474-599
Levetiracetam 750 mg/1 · Tablet, Film coated, Extended release · Oral · UCB, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50474-599-66 | 50474059966 | 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50474-599-66)Marketed from Apr 1, 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)
- Keppra XRSuffix: XR
- Generic name (nonproprietary)
- levetiracetam
- Active ingredients
- Levetiracetam — 750 mg/1
- Dosage form
- Tablet, Film coated, Extended release
- Route
- Oral
- Labeler
- UCB, Inc.NDC labeler code 50474
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 022285
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
- Identifiers
- Product ID 50474-599_38534148-3717-03b3-e063-6394a90a0f1eSPL ID 38534148-3717-03b3-e063-6394a90a0f1eSPL set ID 2919e43b-69a8-434c-a2d2-1f3ecd7554c0RxCUI 807832, 807834, 846378, 847673UNII 44YRR34555
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
N450474059966followed by a unit qualifier and the quantityPackage 50474-0599-66. 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 XR ® is indicated for the treatment of partial-onset seizures in patients 12 years of age and older. KEPPRA XR is indicated for the treatment of partial-onset seizures in patients 12 years of age and older ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 50474-599
- What is NDC 50474-599?
- 50474-599 is the product NDC for Keppra XR (levetiracetam), Levetiracetam 750 mg/1 tablet, film coated, extended release, 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 XR (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 XR?
- 1 other product NDC are listed under this name. See all Keppra XR NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Keppra XR products
Other finished products listed under the same name: strengths, forms and labelers.
Other NDCs under NDA 022285
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.