Benzonatate
NDC Package 65841-615-01

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 discontinued by the firm.

Benzonatate is a medication used to treat coughs caused by the common cold and other breathing problems (e.g., pneumonia, bronchitis, emphysema, asthma). Marketed by Cadila Healthcare Limited, this product is identified by NDC 65841-615 and is authorized under FDA application ANDA040597.

Identification & Billing

NDC Package Code
65841-615-01
Package Description
100 CAPSULE in 1 BOTTLE
Product Code
65841-615
11-Digit Billing Format
65841061501

Clinical Specifications

Proprietary Name
Benzonatate
Dosage Form
-
Usage Information
This medication is used to treat coughs caused by the common cold and other breathing problems (e.g., pneumonia, bronchitis, emphysema, asthma). It works by reducing the reflex in the lungs that causes the urge to cough. Use of this medication is not recommended in children younger than 10 years. Discuss the risks and benefits with your doctor.

Regulatory & Marketing

Labeler Name
Cadila Healthcare Limited
FDA Application #
ANDA040597
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-04-2007
End Marketing Date
08-06-2021
Listing Expiration
08-06-2021
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 65841-615-01 identifies a specific commercial package of 100 capsule in 1 bottle of Benzonatate, labeled by Cadila Healthcare Limited. 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 Cadila Healthcare Limited on September 04, 2007. The current certification is valid through August 06, 2021.

What are the primary indications for this medication?

This medication is used to treat coughs caused by the common cold and other breathing problems (e.g., pneumonia, bronchitis, emphysema, asthma). It works by reducing the reflex in the lungs that causes the urge to cough. Use of this medication is not recommended in children younger than 10 years. Discuss the risks and benefits with your doctor.

How is this Cadila Healthcare Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 65841061501. 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)
65841-615-01
11-Digit CMS (5-4-2)
65841-0615-01

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