Sulfamethoxazole and Trimethoprim

Product NDC
50090-4430
11-digit product format
500904430
Labeler code
50090
Product ID
50090-4430_054c30c8-9585-4069-8923-f073ddf542da
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sulfamethoxazole and Trimethoprim
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA090624
Marketing category
ANDA
Marketing start
2010-02-16
Marketing end
0000-00-00
Substance
SULFAMETHOXAZOLE; TRIMETHOPRIM
Active strength
800 mg/1; mg/1
Pharmacologic classes
Sulfonamide Antimicrobial [EPC],Sulfonamides [CS],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

Related Records

Related UNII Ingredients

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

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-4430-05009044300014 TABLET in 1 BOTTLE (50090-4430-0) 14 tablet2019-07-190000-00-00NoNoCurrent
50090-4430-15009044300114 TABLET in 1 BOTTLE (50090-4430-1) 14 tablet2019-07-190000-00-00NoNoCurrent

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Sulfamethoxazole and Trimethoprim Tablets, USPA-S Medication Solutions2020-07-09Human Prescription Drug Label1