FDA.reportPublic FDA data

polymyxin b sulfate and trimethoprim sulfate

Product NDC
70518-4381
11-digit product format
705184381
Labeler code
70518
Product ID
70518-4381_396b50c4-6ca8-360c-e063-6394a90a263d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
polymyxin b sulfate and trimethoprim sulfate
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
REMEDYREPACK INC.
Application
ANDA211572
Marketing category
ANDA
Marketing start
2025-07-01
Substance
POLYMYXIN B SULFATE; TRIMETHOPRIM
Active strength
10000; 1 [iU]/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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
polymyxin b sulfate and trimethoprim sulfate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POLYMYXIN B SULFATE10000 [iU]/mL
TRIMETHOPRIM1 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii19371312D4, AN164J8Y0X
Rxcui244967

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-4381-0polymyxin b sulfate and trimethoprim sulfate1 in 1 CARTONSOLUTION/ DROPS12
70518-4381-0polymyxin b sulfate and trimethoprim sulfate10 mL in 1 BOTTLESOLUTION/ DROPS102

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
244967polymyxin B sulfate 10,000 UNT / trimethoprim sulfate 1 MG in ML Ophthalmic SolutionPSNc68818b2-d849-41d2-be07-731244afbbac2
244967polymyxin B 10000 UNT/ML / trimethoprim 1 MG/ML Ophthalmic SolutionSCDc68818b2-d849-41d2-be07-731244afbbac2
244967polymyxin B 10,000 UNT / trimethoprim (as trimethoprim sulfate) 0.1 % Ophthalmic SolutionSYc68818b2-d849-41d2-be07-731244afbbac2
244967polymyxin B 10,000 UNT / trimethoprim 0.1 % Ophthalmic SolutionSYc68818b2-d849-41d2-be07-731244afbbac2
244967Polymyxin B 10000 UNT/ML / TMP 1 MG/ML Ophthalmic SolutionSYc68818b2-d849-41d2-be07-731244afbbac2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-4381-0705184381001 BOTTLE in 1 CARTON (70518-4381-0) / 10 mL in 1 BOTTLE1 bottle2025-07-01NoNoHistorical