Levetiracetam Tablet
NDC Package 76282-246-12

11-digit billing NDC: 76282024612 · Billing unit: EA · 120 EA per package
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Levetiracetam tablets is uSP are indicated as adjunctive therapy in the treatment of partial onset seizures in adults and children 4 years of age and older with epilepsy.Information describing the use of levetiracetam in pediatric patients less than 4 years of age as adjunctive therapy in the treatment of partial onset seizures is approved for UCB, Inc.’s levetiracetam tablets and oral solution. This formulation utilizes a tablet delivery system. Marketed by Exelan Pharmaceuticals, Inc., this product is identified by NDC 76282-246 and is authorized under FDA application ANDA078234.

Identification & Billing

NDC Package Code
76282-246-12
Package Description
120 TABLET in 1 BOTTLE
Product Code
76282-246
11-Digit Billing Format
76282024612
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
120 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Levetiracetam
Non-Proprietary Name
Levetiracetam
Substance Name
Levetiracetam
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
LEVETIRACETAM 250 mg/1
Pharmacologic Class
Decreased Central Nervous System Disorganized Electrical Activity - [PE] (Physiologic Effect)
Usage Information
Levetiracetam tablets, USP are indicated as adjunctive therapy in the treatment of partial onset seizures in adults and children 4 years of age and older with epilepsy.Information describing the use of levetiracetam in pediatric patients less than 4 years of age as adjunctive therapy in the treatment of partial onset seizures is approved for UCB, Inc.’s levetiracetam tablets and oral solution. However, due to UCB Inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.

Regulatory & Marketing

Labeler Name
Exelan Pharmaceuticals, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA078234
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
01-15-2009
Listing Expiration
12-31-2027
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 76282-246-12 identifies a specific commercial package of 120 tablet in 1 bottle of Levetiracetam, a human prescription drug labeled by Exelan Pharmaceuticals, Inc.. This tablet is formulated for oral use and contains levetiracetam as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Exelan Pharmaceuticals, Inc. on January 15, 2009. The current certification is valid through December 31, 2027.

How is this Exelan Pharmaceuticals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 76282024612. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 120 total billable units per package. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
76282-246-12
11-Digit CMS (5-4-2)
76282-0246-12

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.