Leader Tioconastat 1
NDC Package 37205-296-03

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 discontinued by the firm.

Leader Tioconastat 1 is a . Marketed by Cardinal Health, this product is identified by NDC 37205-296 and is authorized under FDA application ANDA075915.

Identification & Billing

NDC Package Code
37205-296-03
Package Description
1 POUCH in 1 CARTON / 1 APPLICATOR in 1 POUCH / 4.6 g in 1 APPLICATOR
Product Code
37205-296
11-Digit Billing Format
37205029603
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
Units Per Package
4.6 GM

Clinical Specifications

Proprietary Name
Leader Tioconastat 1 1 Dose Treatment
Dosage Form
-

Regulatory & Marketing

Labeler Name
Cardinal Health
FDA Application #
ANDA075915
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
04-03-2008
End Marketing Date
07-01-2019
Listing Expiration
07-01-2019
Exclude Flag
D
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 37205-296-03 identifies a specific commercial package of 1 pouch in 1 carton / 1 applicator in 1 pouch / 4.6 g in 1 applicator of Leader Tioconastat 1 1 Dose Treatment, labeled by Cardinal Health. 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 Cardinal Health on April 03, 2008. The current certification is valid through July 01, 2019.

How is this Cardinal Health product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 37205029603. Quantities are measured in per "gm or gram", products billed per gram are products measured by weight.. There are 4.6 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)
37205-296-03
11-Digit CMS (5-4-2)
37205-0296-03

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