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Sulfamethoxazole and Trimethoprim

Sulfamethoxazole and Trimethoprim Tablets, USP

Approved
Approval ID

f7f97520-d063-ec87-e053-6294a90aae0c

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Mar 28, 2023

Manufacturers
FDA

Northwind Pharmaceuticals, LLC

DUNS: 036986393

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Sulfamethoxazole and Trimethoprim

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code51655-188
Application NumberANDA090624
Product Classification
M
Marketing Category
C73584
G
Generic Name
Sulfamethoxazole and Trimethoprim
Product Specifications
Route of AdministrationORAL
Effective DateMarch 28, 2023
FDA Product Classification

INGREDIENTS (7)

DOCUSATE SODIUMInactive
Code: F05Q2T2JA0
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
SULFAMETHOXAZOLEActive
Quantity: 800 mg in 1 1
Code: JE42381TNV
Classification: ACTIB
TRIMETHOPRIMActive
Quantity: 160 mg in 1 1
Code: AN164J8Y0X
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT

Drug Labeling Information

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 6/3/2021

INDICATIONS AND USAGE

To reduce the development of drug-resistant bacteria and maintain the effectiveness of sulfamethoxazole and trimethoprim tablets and other antibacterial drugs, sulfamethoxazole and trimethoprim tablets 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 tablets 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 tablets in pediatric patients under two years of age. Sulfamethoxazole and trimethoprim tablets are 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 a physician deems that sulfamethoxazole and trimethoprim tablets 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 jirovecii Pneumonia****


For the treatment of documented Pneumocystis jirovecii pneumonia and for prophylaxis against P. jirovecii pneumonia in individuals who are immunosuppressed and considered to be at an increased risk of developing P. jirovecii pneumonia.

Traveler's Diarrhea in Adults

For the treatment of traveler's diarrhea due to susceptible strains of enterotoxigenic E. coli.

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Sulfamethoxazole and Trimethoprim - FDA Drug Approval Details