POLYMYXIN B SULFATE and TRIMETHOPRIM SULFATE

Product NDC
70518-3206
11-digit product format
705183206
Labeler code
70518
Product ID
70518-3206_e39d06b1-2268-7701-e053-2a95a90a95a6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
polymyxin B sulfate, trimethoprim sulfate
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
REMEDYREPACK INC.
Application
NDA050567
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2021-08-30
Marketing end
0000-00-00
Substance
POLYMYXIN B SULFATE; TRIMETHOPRIM SULFATE
Active strength
10000 [USP'U]/mL; mg/mL
Pharmacologic classes
Cytochrome P450 2C8 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Polymyxin-class Antibacterial [EPC], Polymyxins [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 formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-3206-0705183206001 BOTTLE, DROPPER in 1 CARTON (70518-3206-0) > 10 mL in 1 BOTTLE, DROPPER2021-08-300000-00-00NoNoCurrent