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  5. NDC Package Code: 53808-0977-1 Ethambutol Hydrochloride

NDC Package 53808-0977-1 Ethambutol Hydrochloride

View Billable Units, 11-Digit Format, RxNorm

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.

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
53808-0977-1
Package Description:
30 TABLET in 1 BLISTER PACK
Product Code:
53808-0977
Proprietary Name:
Ethambutol Hydrochloride
Usage Information:
Ethambutol Hydrochloride Tablets are 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.
11-Digit NDC Billing Format:
53808097701
NDC to RxNorm Crosswalk:
  • RxCUI: 995607 - ethambutol HCl 400 MG Oral Tablet
  • RxCUI: 995607 - ethambutol hydrochloride 400 MG Oral Tablet
    • Labeler Name:
    State Of Florida Doh Central Pharmacy
    Sample Package:
    No
    Start Marketing Date:
    07-01-2009
    Listing Expiration Date:
    12-31-2017
    Exclude Flag:
    I
    Code Structure:

    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 disclaimer below.

    Frequently Asked Questions

    What is NDC 53808-0977-1?

    The NDC Packaged Code 53808-0977-1 is assigned to a package of 30 tablet in 1 blister pack of Ethambutol Hydrochloride, labeled by State Of Florida Doh Central Pharmacy. The product's dosage form is and is administered via form.

    Is NDC 53808-0977 included in the NDC Directory?

    No, Ethambutol Hydrochloride with product code 53808-0977 is excluded from the NDC Directory because it's listing has been INACTIVATED by FDA. The product was first marketed by State Of Florida Doh Central Pharmacy on July 01, 2009 and its listing in the NDC Directory is set to expire on December 31, 2017 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 53808-0977-1?

    The 11-digit format is 53808097701. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-4-1 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-4-153808-0977-15-4-253808-0977-01