Sulfamethoxazole and Trimethoprim

Basic Information

Product Name

FDA Product Code

72789-018

Regulatory Information

NDC Product Code

72789-018

Application Number

ANDA090624

Marketing Category

C73584

Effective Date

April 4, 2023

Territorial Authority

USA

FDA Title

Sulfamethoxazole and Trimethoprim Tablets, USP

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

DOCUSATE SODIUM

Code: F05Q2T2JA0

Class Code: IACT

STARCH, CORN

Code: O8232NY3SJ

Class Code: IACT

SODIUM STARCH GLYCOLATE TYPE A POTATO

Code: 5856J3G2A2

Class Code: IACT

SULFAMETHOXAZOLE

Quantity: 800 mg in 1 1

Code: JE42381TNV

Class Code: ACTIB

TRIMETHOPRIM

Quantity: 160 mg in 1 1

Code: AN164J8Y0X

Class Code: ACTIB

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

SODIUM BENZOATE

Code: OJ245FE5EU

Class Code: IACT

Active Moieties