Dicloxacillin Sodium
NDC Package 67296-0122-1

11-digit billing NDC: 67296012201
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.

Dicloxacillin Sodium is to reduce the development of drug-resistant bacteria and maintain the effectiveness of dicloxacillin sodium capsules USP and other antibacterial drugs, dicloxacillin sodium capsules USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. Marketed by Redpharm Drug Inc., this product is identified by NDC 67296-0122 and is authorized under FDA application ANDA062286.

Identification & Billing

NDC Package Code
67296-0122-1
Package Description
40 CAPSULE in 1 BOTTLE
Product Code
67296-0122
11-Digit Billing Format
67296012201
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Dicloxacillin Sodium
Dosage Form
-
Usage Information
To reduce the development of drug-resistant bacteria and maintain the effectiveness of dicloxacillin sodium capsules USP and other antibacterial drugs, dicloxacillin sodium capsules USP 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.Dicloxacillin is indicated in the treatment of infections caused by penicillinase-producing staphylococci which have demonstrated susceptibility to the drug. Cultures and susceptibility tests should be performed initially to determine the causative organisms and their sensitivity to the drug. (see CLINICAL PHARMACOLOGY – Susceptibility Plate Testing).Dicloxacillin may be used to initiate therapy in suspected cases of resistant staphylococcal infections prior to the availability of laboratory test results. The penicillinase-resistant penicillins should not be used in infections caused by organisms susceptible to penicillin G. If the susceptibility tests indicate that the infection is due to an organism other than a resistant staphylococcus, therapy should not be continued with a penicillinase-resistant penicillin.

Regulatory & Marketing

Labeler Name
Redpharm Drug Inc.
FDA Application #
ANDA062286
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
01-20-2011
Listing Expiration
12-31-2017
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 67296-0122-1 identifies a specific commercial package of 40 capsule in 1 bottle of Dicloxacillin Sodium, labeled by Redpharm Drug Inc.. 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 Redpharm Drug Inc. on January 20, 2011. The current certification is valid through December 31, 2017.

How is this Redpharm Drug Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 67296012201. 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)
67296-0122-1
11-Digit CMS (5-4-2)
67296-0122-01

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