Sulfamethoxazole and Trimethoprim
Approved
Approval ID
4196e73b-5aec-2ede-e054-00144ff8d46c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 15, 2024
Manufacturers
FDA
RedPharm Drug, Inc.
DUNS: 828374897
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 Code67296-0387
Application NumberANDA071017
Product Classification
M
Marketing Category
C73584
G
Generic Name
Sulfamethoxazole and Trimethoprim
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 15, 2024
FDA Product Classification
INGREDIENTS (7)
DOCUSATE SODIUMInactive
Code: F05Q2T2JA0
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SULFAMETHOXAZOLEActive
Quantity: 800 mg in 1 1
Code: JE42381TNV
Classification: ACTIB
TRIMETHOPRIMActive
Quantity: 160 mg in 1 1
Code: AN164J8Y0X
Classification: ACTIB