POLYMYXIN B SULFATE AND TRIMETHOPRIM

Product NDC
61919-115
11-digit product format
619190115
Labeler code
61919
Product ID
61919-115_4ac9725b-ce6c-3410-e054-00144ff8d46c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
POLYMYXIN B SULFATE AND TRIMETHOPRIM
Dosage form
SOLUTION
Route
OPHTHALMIC
Labeler
DIRECT RX
Application
ANDA064211
Marketing category
ANDA
Marketing start
2017-03-15
Marketing end
0000-00-00
Substance
POLYMYXIN B SULFATE; TRIMETHOPRIM SULFATE
Active strength
10000 [USP'U]/mL; mg/mL
Pharmacologic classes
Polymyxin-class Antibacterial [EPC],Polymyxins [CS],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
2020-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-115-106191901151010 mL in 1 BOTTLE, PLASTIC (61919-115-10) 10 ml2017-03-150000-00-00NoNoCurrent