Sulfamethoxazole and Trimethoprim

Product NDC
55289-457
11-digit product format
552890457
Labeler code
55289
Product ID
55289-457_d9f63b39-f83e-d396-e053-2995a90ad48f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sulfamethoxazole and Trimethoprim
Dosage form
TABLET
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA076899
Marketing category
ANDA
Marketing start
2010-02-25
Marketing end
0000-00-00
Substance
SULFAMETHOXAZOLE; TRIMETHOPRIM
Active strength
400 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
2023-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55289-457-105528904571010 TABLET in 1 BOTTLE, PLASTIC (55289-457-10) 10 tablet2011-05-050000-00-00NoNoCurrent
55289-457-205528904572020 TABLET in 1 BOTTLE, PLASTIC (55289-457-20) 20 tablet2011-05-050000-00-00NoNoCurrent