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  5. NDC Package Code: 68084-280-01 Ethambutol Hydrochloride

NDC Package 68084-280-01 Ethambutol Hydrochloride

Tablet Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

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:
68084-280-01
Package Description:
100 BLISTER PACK in 1 BOX, UNIT-DOSE / 1 TABLET in 1 BLISTER PACK (68084-280-11)
Product Code:
68084-280
Proprietary Name:
Ethambutol Hydrochloride
Non-Proprietary Name:
Ethambutol Hydrochloride
Substance Name:
Ethambutol Hydrochloride
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 isoniazid  Ethambutol 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:
68084028001
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
100 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 995607 - ethambutol HCl 400 MG Oral Tablet
  • RxCUI: 995607 - ethambutol hydrochloride 400 MG Oral Tablet
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    American Health Packaging
    Dosage Form:
    Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • ETHAMBUTOL HYDROCHLORIDE 400 mg/1
    • Pharmacologic Class(es):
  • Antimycobacterial - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    ANDA078939
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    11-02-2009
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    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 68084-280-01?

    The NDC Packaged Code 68084-280-01 is assigned to a package of 100 blister pack in 1 box, unit-dose / 1 tablet in 1 blister pack (68084-280-11) of Ethambutol Hydrochloride, a human prescription drug labeled by American Health Packaging. The product's dosage form is tablet and is administered via oral form.

    Is NDC 68084-280 included in the NDC Directory?

    Yes, Ethambutol Hydrochloride with product code 68084-280 is active and included in the NDC Directory. The product was first marketed by American Health Packaging on November 02, 2009 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 68084-280-01?

    The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 100.

    What is the 11-digit format for NDC 68084-280-01?

    The 11-digit format is 68084028001. 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 5-3-2 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
    5-3-268084-280-015-4-268084-0280-01