Levetiracetam
NDC Package 16252-577-01

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Levetiracetam is used to treat seizures (epilepsy). Marketed by Actavis Pharma, Inc., this product is identified by NDC 16252-577 and is authorized under FDA application ANDA078797.

Identification & Billing

NDC Package Code
16252-577-01
Package Description
100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
Product Code
16252-577
11-Digit Billing Format
16252057701

Clinical Specifications

Proprietary Name
Levetiracetam
Dosage Form
-
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
Actavis Pharma, Inc.
FDA Application #
ANDA078797
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
02-10-2009
End Marketing Date
12-31-2011
Listing Expiration
12-31-2011
Exclude Flag
D
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 16252-577-01 identifies a specific commercial package of 100 tablet, film coated in 1 bottle, plastic of Levetiracetam, labeled by Actavis Pharma, Inc.. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Actavis Pharma, Inc. on February 10, 2009. The current certification is valid through December 31, 2011.

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 Actavis Pharma, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 16252057701. 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)
16252-577-01
11-Digit CMS (5-4-2)
16252-0577-01

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