Levetiracetam Tablet, Film Coated
NDC Package 72189-696-30

11-digit billing NDC: 72189069630
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Levetiracetam tablets is 1.1 Partial-Onset SeizuresLevetiracetam is indicated for the treatment of partial-onset seizures in patients 1 month of age and older.1.2 Myoclonic Seizures in Patients with Juvenile Myoclonic EpilepsyLevetiracetam is indicated as adjunctive therapy for the treatment of myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy.1.3 Primary Generalized Tonic-Clonic SeizuresLevetiracetam is indicated as adjunctive therapy for the treatment of primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy. This formulation utilizes a tablet, film coated delivery system. Marketed by Direct_rx, this product is identified by NDC 72189-696 and is authorized under FDA application ANDA078106.

Identification & Billing

NDC Package Code
72189-696-30
Package Description
30 TABLET, FILM COATED in 1 BOTTLE
Product Code
72189-696
11-Digit Billing Format
72189069630

Clinical Specifications

Proprietary Name
Levetiracetam
Non-Proprietary Name
Levetiracetam
Substance Name
Levetiracetam
Dosage Form
Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
LEVETIRACETAM 250 mg/1
Pharmacologic Class
Decreased Central Nervous System Disorganized Electrical Activity - [PE] (Physiologic Effect)
Usage Information
1.1 Partial-Onset SeizuresLevetiracetam is indicated for the treatment of partial-onset seizures in patients 1 month of age and older.1.2 Myoclonic Seizures in Patients with Juvenile Myoclonic EpilepsyLevetiracetam is indicated as adjunctive therapy for the treatment of myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy.1.3 Primary Generalized Tonic-Clonic SeizuresLevetiracetam is indicated as adjunctive therapy for the treatment of primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy.

Regulatory & Marketing

Labeler Name
Direct_rx
Product Type
Human Prescription Drug
FDA Application #
ANDA078106
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-30-2026
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 72189-696-30 identifies a specific commercial package of 30 tablet, film coated in 1 bottle of Levetiracetam, a human prescription drug labeled by Direct_rx. This tablet, film coated 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 Direct_rx on October 30, 2026. The current certification is valid through December 31, 2027.

How is this Direct_rx product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 72189069630. 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)
72189-696-30
11-Digit CMS (5-4-2)
72189-0696-30

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