Sulfamethoxazole and Trimethoprim
Sulfamethoxazole and Trimethoprim Tablets, USP
Approved
Approval ID
7f82e5e0-b627-a3f3-e053-2991aa0abaa5
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 17, 2021
Manufacturers
FDA
NuCare Pharmaceuticals,Inc.
DUNS: 010632300
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 Code68071-4710
Application NumberANDA090624
Product Classification
M
Marketing Category
C73584
G
Generic Name
Sulfamethoxazole and Trimethoprim
Product Specifications
Route of AdministrationORAL
Effective DateMarch 17, 2021
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
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
TRIMETHOPRIMActive
Quantity: 160 mg in 1 1
Code: AN164J8Y0X
Classification: ACTIB
SULFAMETHOXAZOLEActive
Quantity: 800 mg in 1 1
Code: JE42381TNV
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT