Polymyxin B Sulfate and Trimethoprim

Product NDC
21695-335
11-digit product format
216950335
Labeler code
21695
Product ID
21695-335_cf4bd790-291e-4c35-83bb-205fb06753b6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
polymyxin B sulfate and trimethoprim
Dosage form
SOLUTION
Route
OPHTHALMIC
Labeler
Rebel Distributors Corp
Application
ANDA064211
Marketing category
ANDA
Marketing start
1998-04-13
Marketing end
0000-00-00
Substance
POLYMYXIN B SULFATE; TRIMETHOPRIM SULFATE
Active strength
10000 mL/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
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4ce811b5-329e-27f8-b5ff-66d52b435c00Product name320240108
8d30c4f0-0228-cea4-e3aa-f19064c47f27Product name320221128
6e20c430-5e8f-85da-1b03-f7dbc0c51fadProduct name320190926
25340b3b-3e4c-4ff8-abf6-3e62ec46bd0cProduct name120160603
b045ad64-0f28-9a02-2f9b-b34d94fb2278Product name120140508
c1381fd7-868a-f499-ef90-8f6d3e3ee6b3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
21695-335-102019-09-24C16284748780-1934fe258-4a37-48b1-e053-8cdaa90a720aPolymyxin B Sulfate and Trimethoprim Ophthalmic Solution, USP Sterile

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-335-10Polymyxin B Sulfate and Trimethoprim10 mL in 1 BOTTLE, PLASTICSOLUTION101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-335-10ML - Milliliter21695-335bb010707-cd3d-4e7a-b595-b305b928f32a12012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-335POLYMYXIN B SULFATE AND TRIMETHOPRIM SOLUTION [REBEL DISTRIBUTORS CORP]1Legacy NDC, 1 package rows20110113_cf4bd790-291e-4c35-83bb-205fb06753b6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
244967polymyxin B sulfate 10,000 UNT / trimethoprim sulfate 1 MG in ML Ophthalmic SolutionPSNcf4bd790-291e-4c35-83bb-205fb06753b61
244967polymyxin B 10000 UNT/ML / trimethoprim 1 MG/ML Ophthalmic SolutionSCDcf4bd790-291e-4c35-83bb-205fb06753b61
244967polymyxin B 10,000 UNT / trimethoprim (as trimethoprim sulfate) 0.1 % Ophthalmic SolutionSYcf4bd790-291e-4c35-83bb-205fb06753b61
244967polymyxin B 10,000 UNT / trimethoprim 0.1 % Ophthalmic SolutionSYcf4bd790-291e-4c35-83bb-205fb06753b61
244967Polymyxin B 10000 UNT/ML / TMP 1 MG/ML Ophthalmic SolutionSYcf4bd790-291e-4c35-83bb-205fb06753b61

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
21695-335-102169503351010 mL in 1 BOTTLE, PLASTIC10 mlHistorical