Levetiracetam Injection, Solution, Concentrate
NDC Package 68225-021-01

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 an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Levetiracetam injection is levetiracetam is used to treat seizures (epilepsy). This formulation utilizes a injection, solution, concentrate delivery system. Marketed by Patheon Italia S.p.a., this product is identified by NDC 68225-021.

Identification & Billing

NDC Package Code
68225-021-01
Package Description
180 VIAL in 1 BOX / 5 mL in 1 VIAL
Product Code
68225-021
11-Digit Billing Format
68225002101

Clinical Specifications

Proprietary Name
Levetiracetam
Non-Proprietary Name
Levetiracetam
Substance Name
Levetiracetam
Dosage Form
Injection, Solution, Concentrate - A sterile preparation for parenteral use which, upon the addition of suitable solvents, yields a solution conforming in all respects to the requirements for Injections.
Active Ingredient(s)
LEVETIRACETAM 500 mg/5mL
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
Patheon Italia S.p.a.
Product Type
Bulk Ingredient
Marketing Category
DRUG FOR FURTHER PROCESSING - A drug (other than the bulk ingredient API) that is in an interim stage of manufacture, processing, preparation, or packaging, and not ready for human or animal use.
Start Marketing Date
08-23-2006
Listing Expiration
12-31-2026
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

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 68225-021-01 identifies a specific commercial package of 180 vial in 1 box / 5 ml in 1 vial of Levetiracetam (UNFINISHED drug), a bulk ingredient labeled by Patheon Italia S.p.a.. This injection, solution, concentrate is formulated for 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 Patheon Italia S.p.a. on August 23, 2006. The current certification is valid through December 31, 2026.

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 Patheon Italia S.p.a. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68225002101. 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)
68225-021-01
11-Digit CMS (5-4-2)
68225-0021-01

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