POLYMYXIN B SULFATE AND TRIMETHOPRIM SULFATE

Product NDC
61919-233
11-digit product format
619190233
Labeler code
61919
Product ID
61919-233_f2030f1c-9992-4b65-e053-2995a90ac5eb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
POLYMYXIN B SULFATE AND TRIMETHOPRIM SULFATE
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
DIRECT RX
Application
NDA050567
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2014-01-01
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
2024-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61919-233-102025-01-30C16284748780-12cef2736-7114-d83d-e063-dadaa90ab31f1a01d41b-3da1-4938-9e71-499320c72dd2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-233-10ML - Milliliter61919-233c5e0e756-69ca-4177-8579-29813bf1810f12015-03-03

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-233POLYMYXIN B SULFATE AND TRIMETHOPRIM SULFATE SOLUTION/ DROPS [DIRECT RX]4Legacy NDC20230112_1a01d41b-3da1-4938-9e71-499320c72dd2.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-233-106191902331010 mL in 1 CARTON (61919-233-10) 10 ml2015-01-010000-00-00NoNoCurrent