Sulfamethoxazole and Trimethoprim
SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLETS USP, 800 mg/160 mg (DOUBLE STRENGTH) AND 400 mg/80 mg
Approved
Approval ID
2b5f951e-4bb2-2c1f-e054-00144ff8d46c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 11, 2016
Manufacturers
FDA
Department of State Health Services, Pharmacy Branch
DUNS: 781992540
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 Code55695-008
Application NumberANDA078060
Product Classification
M
Marketing Category
C73584
G
Generic Name
Sulfamethoxazole and Trimethoprim
Product Specifications
Route of AdministrationORAL
Effective DateMarch 11, 2016
FDA Product Classification
INGREDIENTS (8)
DOCUSATE SODIUMInactive
Code: F05Q2T2JA0
Classification: IACT
POVIDONESInactive
Code: FZ989GH94E
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
SULFAMETHOXAZOLEActive
Quantity: 800 mg in 1 1
Code: JE42381TNV
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TRIMETHOPRIMActive
Quantity: 160 mg in 1 1
Code: AN164J8Y0X
Classification: ACTIB