Sulfamethoxazole And Trimethoprim Suspension
NDC Package 65862-496-01

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

Sulfamethoxazole And Trimethoprim suspension is to reduce the development of drug-resistant bacteria and maintain the effectiveness of sulfamethoxazole and trimethoprim oral suspension, USP and other antibacterial drugs, sulfamethoxazole and trimethoprim oral suspension, USP 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 suspension delivery system. Marketed by Aurobindo Pharma Limited, this product is identified by NDC 65862-496 and is authorized under FDA application ANDA091348.

Identification & Billing

NDC Package Code
65862-496-01
Package Description
100 mL in 1 BOTTLE
Product Code
65862-496
11-Digit Billing Format
65862049601
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
Non-Proprietary Name
Sulfamethoxazole And Trimethoprim
Substance Name
Sulfamethoxazole; Trimethoprim
Dosage Form
Suspension - A liquid1 dosage form that contains solid particles dispersed in a liquid vehicle.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
Usage Information
To reduce the development of drug-resistant bacteria and maintain the effectiveness of sulfamethoxazole and trimethoprim oral suspension, USP and other antibacterial drugs, sulfamethoxazole and trimethoprim oral suspension, 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 empiric selection of therapy. Urinary Tract Infections For the treatment of urinary tract infections due to susceptible strains of the following organisms: Escherichia coli, Klebsiella species, Enterobacter species, Morganella morganii, Proteus mirabilis and Proteus vulgaris. It is recommended that initial episodes of uncomplicated urinary tract infections be treated with a single effective antibacterial agent rather than the combination. Acute Otitis Media For the treatment of acute otitis media in pediatric patients due to susceptible strains of Streptococcus pneumoniae or Haemophilus influenzae when in the judgment of the physician sulfamethoxazole and trimethoprim offers some advantage over the use of other antimicrobial agents. To date, there are limited data on the safety of repeated use of sulfamethoxazole and trimethoprim oral suspension, USP in pediatric patients under two years of age. Sulfamethoxazole and trimethoprim oral suspension, USP is not indicated for prophylactic or prolonged administration in otitis media at any age. Acute Exacerbations of Chronic Bronchitis in AdultsFor the treatment of acute exacerbations of chronic bronchitis due to susceptible strains of Streptococcus pneumoniae or Haemophilus influenzae when a physician deems that sulfamethoxazole and trimethoprim oral suspension, USP could offer some advantage over the use of a single antimicrobial agent. Shigellosis For the treatment of enteritis caused by susceptible strains of Shigella flexneri and Shigella sonnei when antibacterial therapy is indicated.Pneumocystis  jiroveci Pneumonia For the treatment of documented Pneumocystis jiroveci pneumonia and for prophylaxis against P. jiroveci pneumonia in individuals who are immunosuppressed and considered to be at an increased risk of developing P. jiroveci pneumonia.Traveler's Diarrhea in AdultsFor the treatment of traveler’s diarrhea due to susceptible strains of enterotoxigenic E. coli.

Regulatory & Marketing

Labeler Name
Aurobindo Pharma Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA091348
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-08-2010
Listing Expiration
12-31-2026
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (65862-496). Click a package code to view its specific billing and regulatory data.

65862-496-47
473 mL in 1 BOTTLE
65862-496-50
50 mL 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 65862-496-01 identifies a specific commercial package of 100 ml in 1 bottle of Sulfamethoxazole And Trimethoprim, a human prescription drug labeled by Aurobindo Pharma Limited. This suspension is formulated for oral use and contains sulfamethoxazole; trimethoprim 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 Aurobindo Pharma Limited on June 08, 2010. The current certification is valid through December 31, 2026.

How is this Aurobindo Pharma Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 65862049601. 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)
65862-496-01
11-Digit CMS (5-4-2)
65862-0496-01

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