Levetiracetam Solution
NDC Package 39328-511-40

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

Package Information

Levetiracetam solution is levetiracetam is used to treat seizures (epilepsy). This formulation utilizes a solution delivery system. Marketed by Patrin Pharma, Inc., this product is identified by NDC 39328-511 and is authorized under FDA application ANDA078582.

Identification & Billing

NDC Package Code
39328-511-40
Package Description
4 TRAY in 1 CASE / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE
Product Code
39328-511
11-Digit Billing Format
39328051140
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Levetiracetam
Non-Proprietary Name
Levetiracetam
Substance Name
Levetiracetam
Dosage Form
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
LEVETIRACETAM 100 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
Patrin Pharma, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA078582
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
01-31-2024
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (39328-511). Click a package code to view its specific billing and regulatory data.

39328-511-05
5 mL in 1 CUP, UNIT-DOSE
39328-511-30
3 TRAY in 1 CASE / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE
39328-511-50
5 TRAY in 1 CASE / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE

* 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 39328-511-40 identifies a specific commercial package of 4 tray in 1 case / 10 cup, unit-dose in 1 tray / 5 ml in 1 cup, unit-dose of Levetiracetam, a human prescription drug labeled by Patrin Pharma, Inc.. This solution 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 Patrin Pharma, Inc. on January 31, 2024. 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 Patrin Pharma, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 39328051140. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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)
39328-511-40
11-Digit CMS (5-4-2)
39328-0511-40

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