Sulfamethoxazole and Trimethoprim
Sulfamethoxazole and Trimethoprim Oral Suspension, USP
Approved
Approval ID
777da85a-a776-4681-976d-326ec421cfc9
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 8, 2022
Manufacturers
FDA
Pharmaceutical Associates, Inc.
DUNS: 044940096
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 Code0121-0853
Application NumberNDA018615
Product Classification
M
Marketing Category
C73594
G
Generic Name
Sulfamethoxazole and Trimethoprim
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 8, 2022
FDA Product Classification
INGREDIENTS (16)
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMInactive
Code: K679OBS311
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
TRIMETHOPRIMActive
Quantity: 40 mg in 5 mL
Code: AN164J8Y0X
Classification: ACTIB
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT
SULFAMETHOXAZOLEActive
Quantity: 200 mg in 5 mL
Code: JE42381TNV
Classification: ACTIB