Chlordiazepoxide Hydrochloride And Clidinium Bromide Capsule
NDC Package 75826-134-10

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

Package Information

Chlordiazepoxide Hydrochloride And Clidinium Bromide capsules is chlordiazepoxide Hydrochloride and Clidinium Bromide Capsule is indicated to control emotional and somatic factors in gastrointestinal disorders. This formulation utilizes a capsule delivery system. Marketed by Winder Laboratories Llc, this product is identified by NDC 75826-134 and is authorized under FDA application ANDA212344.

Identification & Billing

NDC Package Code
75826-134-10
Package Description
100 CAPSULE in 1 BOTTLE, PLASTIC
Product Code
75826-134
11-Digit Billing Format
75826013410
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
Non-Proprietary Name
Chlordiazepoxide Hydrochloride And Clidinium Bromide
Substance Name
Chlordiazepoxide Hydrochloride; Clidinium Bromide
Dosage Form
Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
Usage Information
Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsule is indicated to control emotional and somatic factors in gastrointestinal disorders. Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsule may also be used 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.
DEA Schedule
Schedule IV (CIV) Substances

Regulatory & Marketing

Labeler Name
Winder Laboratories Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA212344
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-07-2020
Listing Expiration
12-31-2027
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 75826-134-10 identifies a specific commercial package of 100 capsule in 1 bottle, plastic of Chlordiazepoxide Hydrochloride And Clidinium Bromide, a human prescription drug labeled by Winder Laboratories Llc. This capsule is formulated for oral use and contains chlordiazepoxide hydrochloride; clidinium bromide 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 Winder Laboratories Llc on December 07, 2020. The current certification is valid through December 31, 2027.

How is this Winder Laboratories Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 75826013410. 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)
75826-134-10
11-Digit CMS (5-4-2)
75826-0134-10

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