Sulfamethoxazole and Trimethoprim

Product NDC
50090-7008
11-digit product format
500907008
Labeler code
50090
Product ID
50090-7008_d7937760-72c6-46bb-862b-db3d6b5357c1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sulfamethoxazole and Trimethoprim
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA076899
Marketing category
ANDA
Marketing start
2010-09-13
Substance
SULFAMETHOXAZOLE; TRIMETHOPRIM
Active strength
800; 160 mg/1; mg/1
Pharmacologic classes
Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
JE42381TNVSULFAMETHOXAZOLE723-46-6SULFAMETHOXAZOLE
AN164J8Y0XTRIMETHOPRIM738-70-5TRIMETHOPRIM

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-7008-050090700800100 BLISTER PACK in 1 CARTON (50090-7008-0) / 1 TABLET in 1 BLISTER PACK100 blister pack2024-01-04NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Sulfamethoxazole and Trimethoprim Tablets and Double Strength Tablets, USP Rx onlyA-S Medication Solutions2024-01-08HUMAN PRESCRIPTION DRUG LABEL1