Benzonatate
NDC Package 64205-536-30

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.

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 Readymeds, this product is identified by NDC 64205-536 and is authorized under FDA application ANDA040682.

Identification & Billing

NDC Package Code
64205-536-30
Package Description
30 CAPSULE, LIQUID FILLED in 1 BOTTLE
Product Code
64205-536
11-Digit Billing Format
64205053630
RxNorm Crosswalk
RxCUI: 197397 - benzonatate 100 MG Oral Capsule

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
Readymeds
FDA Application #
ANDA040682
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-04-2010
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 64205-536-30 identifies a specific commercial package of 30 capsule, liquid filled in 1 bottle of Benzonatate, labeled by Readymeds. 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 Readymeds on June 04, 2010. The current certification is valid through December 31, 2017.

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 Readymeds product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 64205053630. 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)
64205-536-30
11-Digit CMS (5-4-2)
64205-0536-30

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