Sulfamethoxazole and Trimethoprim

Product NDC
43063-616
11-digit product format
430630616
Labeler code
43063
Product ID
43063-616_cb6ebe72-a90a-f11e-e053-2995a90a8702
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
2010-09-13
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
2022-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43063-616-06430630616066 TABLET in 1 BOTTLE, PLASTIC (43063-616-06) 6 tablet2015-10-270000-00-00NoNoCurrent
43063-616-204306306162020 TABLET in 1 BOTTLE, PLASTIC (43063-616-20) 20 tablet2018-12-130000-00-00NoNoCurrent