POLYMYXIN B SULFATE AND TRIMETHOPRIM

Product NDC
61919-215
11-digit product format
619190215
Labeler code
61919
Product ID
61919-215_50bdf240-8b96-6032-e054-00144ff88e88
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
2017-05-30
Marketing end
0000-00-00
Substance
TRIMETHOPRIM SULFATE; POLYMYXIN B SULFATE
Active strength
1 mg/mL; [USP'U]/mL
Pharmacologic classes
Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA],Polymyxin-class Antibacterial [EPC],Polymyxins [CS]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-215-10ML - Milliliter61919-2151b938bc2-2fcc-411c-8b2d-c1cea08fc8c212019-04-11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-215-106191902151010 mL in 1 BOTTLE, PLASTIC (61919-215-10) 10 ml2017-05-300000-00-00NoNoCurrent