Sulfamethoxazole and Trimethoprim
Sulfamethoxazole and Trimethoprim Tablets and Double Strength Tablets
Approved
Approval ID
27ca999f-2678-4c7d-8f7d-895d0fe77a9f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 21, 2011
Manufacturers
FDA
H.J. Harkins Company, Inc.
DUNS: 147681894
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 Code52959-144
Application NumberANDA076899
Product Classification
M
Marketing Category
C73584
G
Generic Name
Sulfamethoxazole and Trimethoprim
Product Specifications
Route of AdministrationORAL
Effective DateDecember 21, 2011
FDA Product Classification
INGREDIENTS (6)
SULFAMETHOXAZOLEActive
Quantity: 800 mg in 1 1
Code: JE42381TNV
Classification: ACTIB
TRIMETHOPRIMActive
Quantity: 160 mg in 1 1
Code: AN164J8Y0X
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT