Zantanol Tab.
NDC Package 58354-101-02

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.

Zantanol Tab. is • do not take more than the recommended dose• adults (over 15 and under 80 years old): take 2 tablets per session. Marketed by Cho-a Pharm.co.,ltd., this product is identified by NDC 58354-101.

Identification & Billing

NDC Package Code
58354-101-02
Package Description
10 CAPSULE in 1 PACKAGE / 424 mg in 1 CAPSULE (58354-101-01)
Product Code
58354-101
11-Digit Billing Format
58354010102

Clinical Specifications

Proprietary Name
Zantanol Tab.
Dosage Form
-
Usage Information
• do not take more than the recommended dose• adults (over 15 and under 80 years old): take 2 tablets per session. After 5 hours if symptoms last 0.5-1g per session, 1-3 times per day, before meal. Do not take over 4 tablets a day.

Regulatory & Marketing

Labeler Name
Cho-a Pharm.co.,ltd.
Marketing Category
UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.
Start Marketing Date
02-28-2017
End Marketing Date
11-28-2021
Listing Expiration
11-28-2021
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 58354-101-02 identifies a specific commercial package of 10 capsule in 1 package / 424 mg in 1 capsule (58354-101-01) of Zantanol Tab., labeled by Cho-a Pharm.co.,ltd.. 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 Cho-a Pharm.co.,ltd. on February 28, 2017. The current certification is valid through November 28, 2021.

How is this Cho-a Pharm.co.,ltd. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 58354010102. 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)
58354-101-02
11-Digit CMS (5-4-2)
58354-0101-02

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