Chenodal
NDC Package 45043-876-40

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.

Chenodal is chenodiol is used to dissolve certain types of gallstones (non-calcified). Marketed by Manchester Pharmaceuticals Inc., this product is identified by NDC 45043-876 and is authorized under FDA application ANDA091019.

Identification & Billing

NDC Package Code
45043-876-40
Package Description
100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
Product Code
45043-876
11-Digit Billing Format
45043087640
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
100 EA

Clinical Specifications

Proprietary Name
Chenodal
Dosage Form
-
Usage Information
Chenodiol is used to dissolve certain types of gallstones (non-calcified). Chenodiol is a bile acid. Chenodiol may be tried before surgery in patients that are at high risk of complications from gallstone surgery. If the gallstones do not dissolve, emergency surgery may still be needed.

Regulatory & Marketing

Labeler Name
Manchester Pharmaceuticals Inc.
FDA Application #
ANDA091019
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-01-2009
End Marketing Date
07-31-2022
Listing Expiration
07-31-2022
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 45043-876-40 identifies a specific commercial package of 100 tablet, film coated in 1 bottle, plastic of Chenodal, labeled by Manchester Pharmaceuticals Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 100 billable units per package. 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 Manchester Pharmaceuticals Inc. on October 01, 2009. The current certification is valid through July 31, 2022.

What are the primary indications for this medication?

Chenodiol is used to dissolve certain types of gallstones (non-calcified). Chenodiol is a bile acid. Chenodiol may be tried before surgery in patients that are at high risk of complications from gallstone surgery. If the gallstones do not dissolve, emergency surgery may still be needed.

How is this Manchester Pharmaceuticals Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 45043087640. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 100 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)
45043-876-40
11-Digit CMS (5-4-2)
45043-0876-40

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