Bactrim DS
BACTRIM™
Approved
Approval ID
0138a156-859a-48a3-bf5a-e2db0cc7f2f9
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 30, 2009
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
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 Code54868-0337
Application NumberNDA017377
Product Classification
M
Marketing Category
C73594
G
Generic Name
sulfamethoxazole and trimethoprim
Product Specifications
Route of AdministrationORAL
Effective DateJuly 2, 2010
FDA Product Classification
INGREDIENTS (7)
SULFAMETHOXAZOLEActive
Quantity: 800 mg in 1 1
Code: JE42381TNV
Classification: ACTIB
TRIMETHOPRIMActive
Quantity: 160 mg in 1 1
Code: AN164J8Y0X
Classification: ACTIB
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
DOCUSATE SODIUMInactive
Code: F05Q2T2JA0
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT