Benzonatate Capsule, Liquid Filled
NDC Package 67296-2202-3

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

Package Information

Benzonatate capsules is a medication used to treat coughs caused by the common cold and other breathing problems (e.g., pneumonia, bronchitis, emphysema, asthma). This formulation utilizes a capsule, liquid filled delivery system. Marketed by Redpharm Drug, this product is identified by NDC 67296-2202 and is authorized under FDA application ANDA040682.

Identification & Billing

NDC Package Code
67296-2202-3
Package Description
30 CAPSULE, LIQUID FILLED in 1 BOTTLE
Product Code
67296-2202
11-Digit Billing Format
67296220203

Clinical Specifications

Proprietary Name
Benzonatate
Non-Proprietary Name
Benzonatate
Substance Name
Benzonatate
Dosage Form
Capsule, Liquid Filled - A solid dosage form in which the drug is enclosed within a soluble, gelatin shell which is plasticized by the addition of a polyol, such as sorbitol or glycerin, and is therefore of a somewhat thicker consistency than that of a hard shell capsule; typically, the active ingredients are dissolved or suspended in a liquid vehicle.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
BENZONATATE 200 mg/1
Pharmacologic Class
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
Redpharm Drug
Product Type
Human Prescription Drug
FDA Application #
ANDA040682
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-29-2024
Listing Expiration
12-31-2026
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 67296-2202-3 identifies a specific commercial package of 30 capsule, liquid filled in 1 bottle of Benzonatate, a human prescription drug labeled by Redpharm Drug. This capsule, liquid filled is formulated for oral use and contains benzonatate 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 Redpharm Drug on September 29, 2024. The current certification is valid through December 31, 2026.

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 Redpharm Drug product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 67296220203. 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 (5-4-1)
67296-2202-3
11-Digit CMS (5-4-2)
67296-2202-03

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