Sulfamethoxazole and Trimethoprim
These highlights do not include all the information needed to use SULFAMETHOXAZOLE AND TRIMETHOPRIM INJECTION safely and effectively. See full prescribing information for SULFAMETHOXAZOLE AND TRIMETHOPRIM INJECTION. SULFAMETHOXAZOLE and TRIMETHOPRIM injection, for intravenous use Initial U.S. Approval: 1981
Approved
Approval ID
640f5b0c-748d-4a68-a1de-59cc3e00ed49
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 30, 2022
Manufacturers
FDA
Teva Parenteral Medicines, Inc.
DUNS: 794362533
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 Code0703-9514
Application NumberANDA073303
Product Classification
M
Marketing Category
C73584
G
Generic Name
Sulfamethoxazole and Trimethoprim
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateSeptember 30, 2022
FDA Product Classification
INGREDIENTS (8)
TRIMETHOPRIMActive
Quantity: 16 mg in 1 mL
Code: AN164J8Y0X
Classification: ACTIB
SULFAMETHOXAZOLEActive
Quantity: 80 mg in 1 mL
Code: JE42381TNV
Classification: ACTIB
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
DIETHANOLAMINEInactive
Code: AZE05TDV2V
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SODIUM METABISULFITEInactive
Code: 4VON5FNS3C
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT