Chlordiazepoxide Hydrochloride And Clidinium Bromide
NDC Package 10135-622-01

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.

Chlordiazepoxide Hydrochloride And Clidinium Bromide is based on a review of this drug by the National Academy of Sciences – National Research Council and/or other information, FDA has classified the indications as follows:"Possibly" effective: as adjunctive therapy in the treatment of peptic ulcer and in the treatment of the irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and acute enterocolitis.Final classification of the less-than-effective indications requires further investigation. Marketed by Marlex Pharmaceuticals Inc, this product is identified by NDC 10135-622.

Identification & Billing

NDC Package Code
10135-622-01
Package Description
100 CAPSULE in 1 BOTTLE
Product Code
10135-622
11-Digit Billing Format
10135062201
RxNorm Crosswalk
  • RxCUI: 889614 - chlordiazePOXIDE HCl 5 MG / clidinium bromide 2.5 MG Oral Capsule
  • RxCUI: 889614 - chlordiazepoxide hydrochloride 5 MG / clidinium bromide 2.5 MG Oral Capsule

Clinical Specifications

Proprietary Name
Chlordiazepoxide Hydrochloride And Clidinium Bromide
Dosage Form
-
Usage Information
Based on a review of this drug by the National Academy of Sciences – National Research Council and/or other information, FDA has classified the indications as follows:"Possibly" effective: as adjunctive therapy in the treatment of peptic ulcer and in the treatment of the irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and acute enterocolitis.Final classification of the less-than-effective indications requires further investigation.

Regulatory & Marketing

Labeler Name
Marlex Pharmaceuticals Inc
Marketing Category
UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.
Start Marketing Date
07-01-2016
Listing Expiration
12-31-2017
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 10135-622-01 identifies a specific commercial package of 100 capsule in 1 bottle of Chlordiazepoxide Hydrochloride And Clidinium Bromide, labeled by Marlex Pharmaceuticals Inc. 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 Marlex Pharmaceuticals Inc on July 01, 2016. The current certification is valid through December 31, 2017.

How is this Marlex Pharmaceuticals Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 10135062201. 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)
10135-622-01
11-Digit CMS (5-4-2)
10135-0622-01

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