Benzonatate Capsule
NDC Package 68071-5083-3

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

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 delivery system. Marketed by Nucare Pharmaceuticals,inc., this product is identified by NDC 68071-5083 and is authorized under FDA application ANDA206948.

Identification & Billing

NDC Package Code
68071-5083-3
Package Description
30 CAPSULE in 1 BOTTLE
Product Code
68071-5083
11-Digit Billing Format
68071508303
RxNorm Crosswalk
RxCUI: 197397 - benzonatate 100 MG Oral Capsule

Clinical Specifications

Proprietary Name
Benzonatate
Non-Proprietary Name
Benzonatate
Substance Name
Benzonatate
Dosage Form
Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
BENZONATATE 100 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
Nucare Pharmaceuticals,inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA206948
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-21-2018
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (68071-5083). Click a package code to view its specific billing and regulatory data.

68071-5083-5
15 CAPSULE 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 68071-5083-3 identifies a specific commercial package of 30 capsule in 1 bottle of Benzonatate, a human prescription drug labeled by Nucare Pharmaceuticals,inc.. This capsule 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 Nucare Pharmaceuticals,inc. on December 21, 2018. 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 Nucare Pharmaceuticals,inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68071508303. 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)
68071-5083-3
11-Digit CMS (5-4-2)
68071-5083-03

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