Levetiracetam
NDC Package 54838-548-80

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 Lannett Company, Inc., this product is identified by NDC 54838-548 and is authorized under FDA application ANDA090263.

Identification & Billing

NDC Package Code
54838-548-80
Package Description
473 mL in 1 BOTTLE, PLASTIC
Product Code
54838-548
11-Digit Billing Format
54838054880
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
473 ML

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
Lannett Company, Inc.
FDA Application #
ANDA090263
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
04-03-2009
End Marketing Date
02-28-2023
Listing Expiration
02-28-2023
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 54838-548-80 identifies a specific commercial package of 473 ml in 1 bottle, plastic of Levetiracetam, labeled by Lannett Company, 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 Lannett Company, Inc. on April 03, 2009. The current certification is valid through February 28, 2023.

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 Lannett Company, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 54838054880. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 473 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)
54838-548-80
11-Digit CMS (5-4-2)
54838-0548-80

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