Sulfamethoxazole And Trimethoprim
NDC Package 54868-0276-0

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
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.

Sulfamethoxazole And Trimethoprim is to reduce the development of drug-resistant bacteria and maintain the effectiveness of sulfamethoxazole and trimethoprim oral suspension and other antibacterial drugs, sulfamethoxazole and trimethoprim oral suspension should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. Marketed by Physicians Total Care, Inc., this product is identified by NDC 54868-0276 and is authorized under FDA application ANDA074650.

Identification & Billing

NDC Package Code
54868-0276-0
Package Description
1 BOTTLE in 1 CARTON / 473 mL in 1 BOTTLE
Product Code
54868-0276
11-Digit Billing Format
54868027600
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk
  • RxCUI: 313134 - sulfamethoxazole 200 MG / trimethoprim 40 MG in 5 mL Oral Suspension
  • RxCUI: 313134 - sulfamethoxazole 40 MG/ML / trimethoprim 8 MG/ML Oral Suspension
  • RxCUI: 313134 - SMX 40 MG/ML / TMP 8 MG/ML Oral Suspension
  • RxCUI: 313134 - sulfamethoxazole 100 MG / trimethoprim 20 MG per 2.5 ML Oral Suspension
  • RxCUI: 313134 - sulfamethoxazole 200 MG / trimethoprim 40 MG per 5 ML Oral Suspension

Clinical Specifications

Proprietary Name
Sulfamethoxazole And Trimethoprim
Dosage Form
-
Usage Information
To reduce the development of drug-resistant bacteria and maintain the effectiveness of sulfamethoxazole and trimethoprim oral suspension and other antibacterial drugs, sulfamethoxazole and trimethoprim oral suspension 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 empiric selection of therapy.

Regulatory & Marketing

Labeler Name
Physicians Total Care, Inc.
FDA Application #
ANDA074650
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-29-1997
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 54868-0276-0 identifies a specific commercial package of 1 bottle in 1 carton / 473 ml in 1 bottle of Sulfamethoxazole And Trimethoprim, 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 December 29, 1997. 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: 54868027600. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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)
54868-0276-0
11-Digit CMS (5-4-2)
54868-0276-00

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