Levetiracetam Injection
NDC Package 68083-152-10

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

Package Information

Levetiracetam injection is levetiracetam is used to treat seizures (epilepsy). This formulation utilizes a injection delivery system. Marketed by Gland Pharma Limited, this product is identified by NDC 68083-152 and is authorized under FDA application ANDA206880.

Identification & Billing

NDC Package Code
68083-152-10
Package Description
10 BAG in 1 CARTON / 100 mL in 1 BAG (68083-152-01)
Product Code
68083-152
11-Digit Billing Format
68083015210
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Levetiracetam
Non-Proprietary Name
Levetiracetam
Substance Name
Levetiracetam
Dosage Form
Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
LEVETIRACETAM 5 mg/mL
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
Gland Pharma Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA206880
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-07-2017
Listing Expiration
12-31-2026
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 68083-152-10 identifies a specific commercial package of 10 bag in 1 carton / 100 ml in 1 bag (68083-152-01) of Levetiracetam, a human prescription drug labeled by Gland Pharma Limited. This injection is formulated for intravenous 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 Gland Pharma Limited on November 07, 2017. 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 Gland Pharma Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68083015210. 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)
68083-152-10
11-Digit CMS (5-4-2)
68083-0152-10

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