Amino Ex
NDC Package 71838-0010-2

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.

Amino Ex is for external use only. Marketed by Kwang Duk Sin Yak Co., Ltd., this product is identified by NDC 71838-0010 and is authorized under FDA application part358H.

Identification & Billing

NDC Package Code
71838-0010-2
Package Description
1 BOTTLE, PUMP in 1 CARTON / 500 mL in 1 BOTTLE, PUMP (71838-0010-1)
Product Code
71838-0010
11-Digit Billing Format
71838001002
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Amino Ex 500ml
Dosage Form
-
Usage Information
For external use only

Regulatory & Marketing

Labeler Name
Kwang Duk Sin Yak Co., Ltd.
FDA Application #
part358H
Marketing Category
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date
06-08-2020
Listing Expiration
12-31-2021
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 71838-0010-2 identifies a specific commercial package of 1 bottle, pump in 1 carton / 500 ml in 1 bottle, pump (71838-0010-1) of Amino Ex 500ml, labeled by Kwang Duk Sin Yak 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 Kwang Duk Sin Yak Co., Ltd. on June 08, 2020. The current certification is valid through December 31, 2021.

How is this Kwang Duk Sin Yak Co., Ltd. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 71838001002. 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)
71838-0010-2
11-Digit CMS (5-4-2)
71838-0010-02

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