Ethambutol Hydrochloride
NDC Package 68151-0149-0

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.

Ethambutol Hydrochloride is indicated for the treatment of pulmonary tuberculosis. Marketed by Carilion Materials Management, this product is identified by NDC 68151-0149 and is authorized under FDA application ANDA078939.

Identification & Billing

NDC Package Code
68151-0149-0
Package Description
1 TABLET in 1 PACKAGE
Product Code
68151-0149
11-Digit Billing Format
68151014900
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Ethambutol Hydrochloride
Dosage Form
-
Usage Information
Ethambutol hydrochloride is indicated for the treatment of pulmonary tuberculosis. It should not be used as the sole antituberculous drug, but should be used in conjunction with at least one other antituberculous drug. Selection of the companion drug should be based on clinical experience, considerations of comparative safety and appropriate in-vitro susceptibility studies. In patients who have not received previous antituberculous therapy, i.e., initial treatment, the most frequently used regimens have been the following:Ethambutol plus isoniazidEthambutol plus isoniazid plus streptomycin.In patients who have received previous antituberculous therapy, mycobacterial resistance to other drugs used in initial therapy is frequent. Consequently, in such retreatment patients, ethambutol should be combined with at least one of the second line drugs not previously administered to the patient and to which bacterial susceptibility has been indicated by appropriate in-vitro studies. Antituberculous drugs used with ethambutol have included cycloserine, ethionamide, pyrazinamide, viomycin and other drugs. Isoniazid, aminosalicylic acid, and streptomycin have also been used in multiple drug regimens. Alternating drug regimens have also been utilized.

Regulatory & Marketing

Labeler Name
Carilion Materials Management
FDA Application #
ANDA078939
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
07-04-2009
Listing Expiration
12-31-2018
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 68151-0149-0 identifies a specific commercial package of 1 tablet in 1 package of Ethambutol Hydrochloride, labeled by Carilion Materials Management. 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 Carilion Materials Management on July 04, 2009. The current certification is valid through December 31, 2018.

How is this Carilion Materials Management product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68151014900. 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)
68151-0149-0
11-Digit CMS (5-4-2)
68151-0149-00

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