Moxifloxacin Hydrochloride Tablet, Film Coated
NDC Package 50268-576-13

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Moxifloxacin Hydrochloride tablets is to reduce the development of drug-resistant bacteria and maintain the effectiveness of moxifloxacin hydrochloride tablets and other antibacterial drugs, moxifloxacin hydrochloride tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. This formulation utilizes a tablet, film coated delivery system. Marketed by Avpak, this product is identified by NDC 50268-576 and is authorized under FDA application ANDA202632.

Identification & Billing

NDC Package Code
50268-576-13
Package Description
30 BLISTER PACK in 1 BOX, UNIT-DOSE / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-576-11)
Product Code
50268-576
11-Digit Billing Format
50268057613
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Moxifloxacin Hydrochloride
Non-Proprietary Name
Moxifloxacin Hydrochloride
Substance Name
Moxifloxacin Hydrochloride
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
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
MOXIFLOXACIN HYDROCHLORIDE 400 mg/1
Pharmacologic Class
Usage Information
To reduce the development of drug-resistant bacteria and maintain the effectiveness of moxifloxacin hydrochloride tablets and other antibacterial drugs, moxifloxacin hydrochloride tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.Moxifloxacin hydrochloride tablets are indicated for the treatment of adults (≥ 18 years of age) with infections caused by susceptible isolates of the designated microorganisms in the conditions listed below [see Dosage and Administration (2) and Use in Specific Populations (8.5)].Culture and Susceptibility Testing Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify organisms causing infection and to determine their susceptibility to moxifloxacin [see Clinical Pharmacology (12.4)]. Therapy with moxifloxacin hydrochloride tablets may be initiated before results of these tests are known; once results become available, appropriate therapy should be continued.

Regulatory & Marketing

Labeler Name
Avpak
Product Type
Human Prescription Drug
FDA Application #
ANDA202632
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
07-22-2016
Listing Expiration
12-31-2027
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 50268-576-13 identifies a specific commercial package of 30 blister pack in 1 box, unit-dose / 1 tablet, film coated in 1 blister pack (50268-576-11) of Moxifloxacin Hydrochloride, a human prescription drug labeled by Avpak. This tablet, film coated is formulated for oral use and contains moxifloxacin hydrochloride 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 Avpak on July 22, 2016. The current certification is valid through December 31, 2027.

How is this Avpak product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 50268057613. 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 (5-3-2)
50268-576-13
11-Digit CMS (5-4-2)
50268-0576-13

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