NDC Package 50383-823-16 Sulfamethoxazole And Trimethoprim

View Billable Units, 11-Digit Format, RxNorm

Package Information
Frequently Asked Questions

Package Information

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

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:

50383-823-16

Package Description:

473 mL in 1 BOTTLE

Product Code:

50383-823

Proprietary Name:

Sulfamethoxazole And Trimethoprim

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.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 in pediatric patients under two years of age. Sulfamethoxazole and trimethoprim is not indicated for prophylactic or prolonged administration in otitis media at any age.Acute Exacerbations of Chronic Bronchitis in Adults: For the treatment of acute exacerbations of chronic bronchitis 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 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 Pneumocystis jiroveci pneumonia in individuals who are immunosuppressed and considered to be at an increased risk of developing Pneumocystis jiroveci pneumonia.Traveler’s Diarrhea In Adults: For the treatment of traveler’s diarrhea due to susceptible strains of enterotoxigenic E. coli.

11-Digit NDC Billing Format:

50383082316

Billing Unit:

ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.

NDC to RxNorm Crosswalk:

473 ML

NDC to 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

Labeler Name:

Akorn Operating Company Llc

Sample Package:

Start Marketing Date:

12-29-1997

Listing Expiration Date:

12-31-2023

Exclude Flag:

Code Structure:

50383 - Akorn Operating Company Llc
- 50383-823 - Sulfamethoxazole And Trimethoprim
  - 50383-823-16 - 473 mL in 1 BOTTLE

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 disclaimer below.

Frequently Asked Questions

What is NDC 50383-823-16?

The NDC Packaged Code 50383-823-16 is assigned to a package of 473 ml in 1 bottle of Sulfamethoxazole And Trimethoprim, labeled by Akorn Operating Company Llc. The product's dosage form is and is administered via form.

Is NDC 50383-823 included in the NDC Directory?

No, Sulfamethoxazole And Trimethoprim with product code 50383-823 is excluded from the NDC Directory because it's listing has been INACTIVATED by FDA. The product was first marketed by Akorn Operating Company Llc on December 29, 1997 and its listing in the NDC Directory is set to expire on December 31, 2023 if the product is not updated or renewed by the manufacturer.

What is the NDC billing unit for package 50383-823-16?

The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume. The calculated billable units for this package is 473.

What is the 11-digit format for NDC 50383-823-16?

The 11-digit format is 50383082316. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

10-Digit Format	10-Digit Original Code	11-Digit Format	11-Digit Code
5-3-2	50383-823-16	5-4-2	50383-0823-16

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