Ampicillin
NDC Package 54868-3113-1

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Ampicillin is capsules, USP are indicated in the treatment of infections caused by susceptible strains of the designated organism listed below:INFECTIONS OF THE GENITOURINARY TRACT INCLUDING GONORRHEA: E. Marketed by Physicians Total Care, Inc., this product is identified by NDC 54868-3113 and is authorized under FDA application ANDA064082.

Identification & Billing

NDC Package Code
54868-3113-1
Package Description
14 CAPSULE in 1 BOTTLE
Product Code
54868-3113
11-Digit Billing Format
54868311301
RxNorm Crosswalk
RxCUI: 308212 - ampicillin 500 MG Oral Capsule

Clinical Specifications

Proprietary Name
Ampicillin
Dosage Form
-
Usage Information
Ampicillin Capsules, USP are indicated in the treatment of infections caused by susceptible strains of the designated organism listed below:INFECTIONS OF THE GENITOURINARY TRACT INCLUDING GONORRHEA: E. coli, P. mirabilis, enterococci, Shigella, S. typhosa and other Salmonella, and nonpenicillinaseproducing N. gonorrhoeae.INFECTIONS OF THE RESPIRATORY TRACT: Nonpenicillinase- producing H. influenzae and staphylococci, and streptococci including streptococcus pneumoniae.INFECTIONS OF THE GASTROINTESTINAL TRACT:Shigella, S. typhosa and other Salmonella, E. coli, P. mirabilis, and enterococci.MENINGITIS: N. Meningitides.To reduce the development of drug-resistant bacteria and maintain the effectiveness of ampicillin and other antibacterial drugs, ampicillin 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.Bacteriology studies to determine the causative organisms and their susceptibility to ampicillin should be performed. Therapy may be instituted prior to the results of susceptibility testing.

Regulatory & Marketing

Labeler Name
Physicians Total Care, Inc.
FDA Application #
ANDA064082
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
03-22-2011
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (54868-3113). Click a package code to view its specific billing and regulatory data.

54868-3113-5
30 CAPSULE in 1 BOTTLE

* 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 54868-3113-1 identifies a specific commercial package of 14 capsule in 1 bottle of Ampicillin, labeled by Physicians Total Care, 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 Physicians Total Care, Inc. on March 22, 2011. The current certification is valid through December 31, 2017.

How is this Physicians Total Care, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 54868311301. 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)
54868-3113-1
11-Digit CMS (5-4-2)
54868-3113-01

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