Sulfamethoxazole and Trimethoprim
Sulfamethoxazole and Trimethoprim Oral Suspension, USP
Approved
Approval ID
3e568a2e-421d-4456-a8bf-d983ecee7ad6
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 1, 2010
Manufacturers
FDA
Rebel Distributors Corp
DUNS: 118802834
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 Code21695-701
Application NumberANDA074650
Product Classification
M
Marketing Category
C73584
G
Generic Name
Sulfamethoxazole and Trimethoprim
Product Specifications
Route of AdministrationORAL
Effective DateOctober 21, 2009
FDA Product Classification
INGREDIENTS (16)
SULFAMETHOXAZOLEActive
Quantity: 200 mg in 5 mL
Code: JE42381TNV
Classification: ACTIB
TRIMETHOPRIMActive
Quantity: 40 mg in 5 mL
Code: AN164J8Y0X
Classification: ACTIB
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
CARBOXYMETHYLCELLULOSE SODIUMInactive
Code: K679OBS311
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
CHERRYInactive
Code: BUC5I9595W
Classification: IACT