Tiagabine Hydrochloride Tablet
NDC Package 72205-084-30

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

Package Information

Tiagabine Hydrochloride tablets is tiagabine hydrochloride tablet is indicated as adjunctive therapy in adults and children 12 years and older in the treatment of partial seizures. This formulation utilizes a tablet delivery system. Marketed by Novadoz Pharmaceuticals Llc, this product is identified by NDC 72205-084 and is authorized under FDA application ANDA214816.

Identification & Billing

NDC Package Code
72205-084-30
Package Description
30 TABLET in 1 BOTTLE
Product Code
72205-084
11-Digit Billing Format
72205008430
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
30 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Tiagabine Hydrochloride
Non-Proprietary Name
Tiagabine Hydrochloride
Substance Name
Tiagabine Hydrochloride
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
TIAGABINE HYDROCHLORIDE 2 mg/1
Pharmacologic Class
Usage Information
Tiagabine hydrochloride tablet is indicated as adjunctive therapy in adults and children 12 years and older in the treatment of partial seizures.

Regulatory & Marketing

Labeler Name
Novadoz Pharmaceuticals Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA214816
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-23-2021
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 72205-084-30 identifies a specific commercial package of 30 tablet in 1 bottle of Tiagabine Hydrochloride, a human prescription drug labeled by Novadoz Pharmaceuticals Llc. This tablet is formulated for oral use and contains tiagabine hydrochloride 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 Novadoz Pharmaceuticals Llc on November 23, 2021. The current certification is valid through December 31, 2026.

How is this Novadoz Pharmaceuticals Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 72205008430. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 30 total billable units per package. 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)
72205-084-30
11-Digit CMS (5-4-2)
72205-0084-30

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