Levetiracetam Tablet, Extended Release
NDC Package 68001-113-06

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Levetiracetam tablets is levetiracetam is used to treat seizures (epilepsy). This formulation utilizes a tablet, extended release delivery system. Marketed by Bluepoint Laboratories, this product is identified by NDC 68001-113 and is authorized under FDA application ANDA091399.

Identification & Billing

NDC Package Code
68001-113-06
Package Description
60 TABLET, EXTENDED RELEASE in 1 BOTTLE
Product Code
68001-113
11-Digit Billing Format
68001011306
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
60 EA
RxNorm Crosswalk
  • RxCUI: 807832 - levETIRAcetam 500 MG 24HR Extended Release Oral Tablet
  • RxCUI: 807832 - 24 HR levetiracetam 500 MG Extended Release Oral Tablet
  • RxCUI: 807832 - levetiracetam 500 MG 24 HR Extended Release Oral Tablet
  • RxCUI: 846378 - levETIRAcetam 750 MG 24HR Extended Release Oral Tablet
  • RxCUI: 846378 - 24 HR levetiracetam 750 MG Extended Release Oral Tablet

Clinical Specifications

Proprietary Name
Levetiracetam
Non-Proprietary Name
Levetiracetam
Substance Name
Levetiracetam
Dosage Form
Tablet, Extended Release - A solid dosage form containing a drug which allows at least a reduction in dosing frequency as compared to that drug presented in conventional dosage form.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
LEVETIRACETAM 500 mg/1
Pharmacologic Class
Decreased Central Nervous System Disorganized Electrical Activity - [PE] (Physiologic Effect)
Usage Information
Levetiracetam is used to treat seizures (epilepsy). It belongs to a class of drugs known as anticonvulsants. Levetiracetam may decrease the number of seizures you have.

Regulatory & Marketing

Labeler Name
Bluepoint Laboratories
Product Type
Human Prescription Drug
FDA Application #
ANDA091399
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
02-13-2014
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 68001-113-06 identifies a specific commercial package of 60 tablet, extended release in 1 bottle of Levetiracetam, a human prescription drug labeled by Bluepoint Laboratories. This tablet, extended release 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 Bluepoint Laboratories on February 13, 2014. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

Levetiracetam is used to treat seizures (epilepsy). It belongs to a class of drugs known as anticonvulsants. Levetiracetam may decrease the number of seizures you have.

How is this Bluepoint Laboratories product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68001011306. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 60 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)
68001-113-06
11-Digit CMS (5-4-2)
68001-0113-06

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