POLYMYXIN B SULFATE and TRIMETHOPRIM SULFATE

Product NDC
55700-105
11-digit product format
557000105
Labeler code
55700
Product ID
55700-105_78a70bfc-767a-4459-8069-b0794f6c2c30
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
polymyxin B sulfate, trimethoprim sulfate
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Quality Care Products LLC
Application
NDA050567
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
1997-04-29
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55700-105-102025-01-08C16284748780-11030e365-144e-111a-e063-dadaa90a10e296dfd5b6-70cb-42cf-af30-b81785a8b402
55700-105-102024-01-30C16284748780-11030e365-144e-111a-e063-dadaa90a10e296dfd5b6-70cb-42cf-af30-b81785a8b402

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55700-105-10ML - Milliliter55700-10598b91e90-21fe-4a5a-a399-765f285b307812015-03-03

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55700-105-10557000105101 BOTTLE, DROPPER in 1 CARTON (55700-105-10) > 10 mL in 1 BOTTLE, DROPPER2005-12-310000-00-00NoNoCurrent