Bethanechol Chloride
NDC Package 57664-104-83

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Bethanechol Chloride is a medication used to treat certain bladder problems such as the inability to urinate or empty the bladder completely due to certain causes (e.g., surgery, bladder muscle problems). Marketed by Caraco Pharmaceutical Laboratories, Ltd., this product is identified by NDC 57664-104 and is authorized under FDA application ANDA040897.

Identification & Billing

NDC Package Code
57664-104-83
Package Description
30 TABLET in 1 BOTTLE
Product Code
57664-104
11-Digit Billing Format
57664010483

Clinical Specifications

Proprietary Name
Bethanechol Chloride
Dosage Form
-
Usage Information
This medication is used to treat certain bladder problems such as the inability to urinate or empty the bladder completely due to certain causes (e.g., surgery, bladder muscle problems). It works by helping the bladder muscle to squeeze better, thereby improving your ability to urinate.

Regulatory & Marketing

Labeler Name
Caraco Pharmaceutical Laboratories, Ltd.
FDA Application #
ANDA040897
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
04-30-2009
End Marketing Date
12-30-2016
Listing Expiration
12-30-2016
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (57664-104). Click a package code to view its specific billing and regulatory data.

57664-104-08
100 TABLET in 1 BOTTLE
57664-104-13
500 TABLET in 1 BOTTLE
57664-104-18
1000 TABLET in 1 BOTTLE
57664-104-88
100 TABLET in 1 BOTTLE

* 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 57664-104-83 identifies a specific commercial package of 30 tablet in 1 bottle of Bethanechol Chloride, labeled by Caraco Pharmaceutical Laboratories, 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 Caraco Pharmaceutical Laboratories, Ltd. on April 30, 2009. The current certification is valid through December 30, 2016.

What are the primary indications for this medication?

This medication is used to treat certain bladder problems such as the inability to urinate or empty the bladder completely due to certain causes (e.g., surgery, bladder muscle problems). It works by helping the bladder muscle to squeeze better, thereby improving your ability to urinate.

How is this Caraco Pharmaceutical Laboratories, Ltd. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 57664010483. 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)
57664-104-83
11-Digit CMS (5-4-2)
57664-0104-83

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