Terbinafine Hydrochloride Tablet
NDC Package 43353-893-16

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

Package Information

Terbinafine Hydrochloride tablets is 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. This formulation utilizes a tablet delivery system. Marketed by Aphena Pharma Solutions - Tennessee, Llc, this product is identified by NDC 43353-893 and is authorized under FDA application ANDA077714.

Identification & Billing

NDC Package Code
43353-893-16
Package Description
6000 TABLET in 1 BOTTLE
Product Code
43353-893
11-Digit Billing Format
43353089316
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
6000 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Terbinafine Hydrochloride
Non-Proprietary Name
Terbinafine Hydrochloride
Substance Name
Terbinafine 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)
TERBINAFINE HYDROCHLORIDE 250 mg/1
Pharmacologic Class
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
Aphena Pharma Solutions - Tennessee, Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA077714
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
08-22-2012
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 43353-893-16 identifies a specific commercial package of 6000 tablet in 1 bottle of Terbinafine Hydrochloride, a human prescription drug labeled by Aphena Pharma Solutions - Tennessee, Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 6000 billable units per package. This tablet is formulated for oral use and contains terbinafine 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 Aphena Pharma Solutions - Tennessee, Llc on August 22, 2012. The current certification is valid through December 31, 2026.

How is this Aphena Pharma Solutions - Tennessee, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 43353089316. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 6000 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)
43353-893-16
11-Digit CMS (5-4-2)
43353-0893-16

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