Terbinafine
NDC Package 67296-2103-9

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Terbinafine is tablets are indicated for the treatment of onychomycosis of the toenail or fingernail due to dermatophytes (tinea unguium). Marketed by Redpharm Drug, this product is identified by NDC 67296-2103 and is authorized under FDA application ANDA078297.

Identification & Billing

NDC Package Code
67296-2103-9
Package Description
90 TABLET in 1 BOTTLE
Product Code
67296-2103
11-Digit Billing Format
67296210309

Clinical Specifications

Proprietary Name
Terbinafine
Dosage Form
-
Usage Information
Terbinafine tablets are indicated for the treatment of onychomycosis of the toenail or fingernail due to dermatophytes (tinea unguium). Prior to initiating treatment, appropriate nail specimens for laboratory testing [potassium hydroxide (KOH) preparation, fungal culture, or nail biopsy] should be obtained to confirm the diagnosis of onychomycosis.

Regulatory & Marketing

Labeler Name
Redpharm Drug
FDA Application #
ANDA078297
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
07-02-2007
Listing Expiration
12-31-2025
Exclude Flag
I
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 67296-2103-9 identifies a specific commercial package of 90 tablet in 1 bottle of Terbinafine, labeled by Redpharm Drug. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Redpharm Drug on July 02, 2007. The current certification is valid through December 31, 2025.

How is this Redpharm Drug product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 67296210309. 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 (5-4-1)
67296-2103-9
11-Digit CMS (5-4-2)
67296-2103-09

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