NDC Package 54879-002-01 Ethambutol Hydrochloride

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

Package Information
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:

54879-002-01

Package Description:

12 CARTON in 1 BOX / 12 BOTTLE in 1 CARTON / 100 TABLET, FILM COATED in 1 BOTTLE

Product Code:

54879-002

Proprietary Name:

Ethambutol Hydrochloride

Non-Proprietary Name:

Ethambutol Hydrochloride

Substance Name:

Ethambutol Hydrochloride

Usage Information:

ETHAMBUTOL HCl 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, ie, initial treatment, the most frequently used regimens have been the following:ETHAMBUTOL HCl plus isoniazidETHAMBUTOL HCl 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 HCl 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 HCl 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:

54879000201

Billing Unit:

EA - Billing unit of "each" is used when the product is dispensed in discreet units.

NDC to RxNorm Crosswalk:

12 EA

NDC to RxNorm Crosswalk:

RxCUI: 995599 - ethambutol HCl 100 MG Oral Tablet

RxCUI: 995599 - ethambutol hydrochloride 100 MG Oral Tablet

RxCUI: 995607 - ethambutol HCl 400 MG Oral Tablet

RxCUI: 995607 - ethambutol hydrochloride 400 MG Oral Tablet

Product Type:

Human Prescription Drug

Labeler Name:

Sti Pharma Llc

Dosage Form:

Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.

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:

FDA Application Number:

NDA016320

Marketing Category:

NDA AUTHORIZED GENERIC - A product marketed as a "generic" drug under an approved New Drug Application (NDA), rather than an Abbreviated New Drug Application (ANDA),.

Start Marketing Date:

12-15-2006

Listing Expiration Date:

12-31-2025

Exclude Flag:

Code Structure:

54879 - Sti Pharma Llc
- 54879-002 - Ethambutol Hydrochloride
  - 54879-002-01 - 12 CARTON in 1 BOX / 12 BOTTLE in 1 CARTON / 100 TABLET, FILM COATED in 1 BOTTLE

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 54879-002-01?

The NDC Packaged Code 54879-002-01 is assigned to a package of 12 carton in 1 box / 12 bottle in 1 carton / 100 tablet, film coated in 1 bottle of Ethambutol Hydrochloride, a human prescription drug labeled by Sti Pharma Llc. The product's dosage form is tablet, film coated and is administered via oral form.

Is NDC 54879-002 included in the NDC Directory?

Yes, Ethambutol Hydrochloride with product code 54879-002 is active and included in the NDC Directory. The product was first marketed by Sti Pharma Llc on December 15, 2006 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

What is the NDC billing unit for package 54879-002-01?

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 12.

What is the 11-digit format for NDC 54879-002-01?

The 11-digit format is 54879000201. 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 Format	10-Digit Original Code	11-Digit Format	11-Digit Code
5-3-2	54879-002-01	5-4-2	54879-0002-01

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