FDA.reportPublic FDA data

Polymyxin B Sulfate and Trimethoprim

Product NDC
53217-244
11-digit product format
532170244
Labeler code
53217
Product ID
53217-244_d9d4211b-fc59-4696-807f-67328b067ab6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Polymyxin B Sulfate and Trimethoprim Sulfate
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA064120
Marketing category
ANDA
Marketing start
1997-02-14
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
2019-12-31
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
53217-244-012020-01-31C16284748780-19d75b9d0-099a-f424-e053-dadaa90a57cePolymyxin B Sulfate and Trimethoprim Ophthalmic Solution, USP*

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53217-244-01Polymyxin B Sulfate and Trimethoprim10 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS102
53217-244-01Polymyxin B Sulfate and Trimethoprim1 in 1 CARTONSOLUTION/ DROPS12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53217-244-01ML - Milliliter53217-244a016a77b-77de-493f-aa22-4c5fa4a062dc12016-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53217-244POLYMYXIN B SULFATE AND TRIMETHOPRIM (POLYMYXIN B SULFATE AND TRIMETHOPRIM SULFATE) SOLUTION/ DROPS [AIDAREX PHARMACEUTICALS LLC]2Legacy NDC, 2 package rows20161201_75797aa8-8d02-4404-93db-b09a5e403775.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 SolutionPSN75797aa8-8d02-4404-93db-b09a5e4037752
244967polymyxin B 10000 UNT/ML / trimethoprim 1 MG/ML Ophthalmic SolutionSCD75797aa8-8d02-4404-93db-b09a5e4037752
244967polymyxin B 10,000 UNT / trimethoprim (as trimethoprim sulfate) 0.1 % Ophthalmic SolutionSY75797aa8-8d02-4404-93db-b09a5e4037752
244967polymyxin B 10,000 UNT / trimethoprim 0.1 % Ophthalmic SolutionSY75797aa8-8d02-4404-93db-b09a5e4037752
244967Polymyxin B 10000 UNT/ML / TMP 1 MG/ML Ophthalmic SolutionSY75797aa8-8d02-4404-93db-b09a5e4037752

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
53217-244-015321702440110 mL in 1 BOTTLE, DROPPER10 mlHistorical