Levetiracetam Tablet, Extended Release
NDC Package 81665-101-60

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 tablets is levetiracetam is used to treat seizures (epilepsy). This formulation utilizes a tablet, extended release delivery system. Marketed by Omnivium Pharmaceuticals Llc, this product is identified by NDC 81665-101 and is authorized under FDA application ANDA212688.

Identification & Billing

NDC Package Code
81665-101-60
Package Description
60 TABLET, EXTENDED RELEASE in 1 BOTTLE
Product Code
81665-101
11-Digit Billing Format
81665010160
RxNorm Crosswalk
  • RxCUI: 807832 - levETIRAcetam 500 MG 24HR Extended Release Oral Tablet
  • RxCUI: 807832 - 24 HR levetiracetam 500 MG Extended Release Oral Tablet
  • RxCUI: 807832 - levetiracetam 500 MG 24 HR Extended Release Oral Tablet
  • RxCUI: 846378 - levETIRAcetam 750 MG 24HR Extended Release Oral Tablet
  • RxCUI: 846378 - 24 HR levetiracetam 750 MG Extended Release Oral Tablet

Clinical Specifications

Proprietary Name
Levetiracetam Extended-release
Non-Proprietary Name
Levetiracetam
Substance Name
Levetiracetam
Dosage Form
Tablet, Extended Release - A solid dosage form containing a drug which allows at least a reduction in dosing frequency as compared to that drug presented in conventional dosage form.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
LEVETIRACETAM 500 mg/1
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
Omnivium Pharmaceuticals Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA212688
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
05-05-2023
Listing Expiration
12-31-2027
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 (81665-101). Click a package code to view its specific billing and regulatory data.

81665-101-12
120 TABLET, EXTENDED RELEASE in 1 BOTTLE

* 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 81665-101-60 identifies a specific commercial package of 60 tablet, extended release in 1 bottle of Levetiracetam Extended-release, a human prescription drug labeled by Omnivium Pharmaceuticals Llc. This tablet, extended release 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 Omnivium Pharmaceuticals Llc on May 05, 2023. The current certification is valid through December 31, 2027.

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 Omnivium Pharmaceuticals Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 81665010160. 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)
81665-101-60
11-Digit CMS (5-4-2)
81665-0101-60

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