FDA.reportPublic FDA data

Polymyxin B Sulfate and Trimethoprim

Product NDC
68788-8152
11-digit product format
687888152
Labeler code
68788
Product ID
68788-8152_c4e82b16-02ee-4bc8-962a-34f30267207f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Polymyxin B Sulfate and Trimethoprim Sulfate
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA064120
Marketing category
ANDA
Marketing start
2022-03-14
Substance
POLYMYXIN B SULFATE; TRIMETHOPRIM SULFATE
Active strength
10000; 1 [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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Polymyxin B Sulfate and Trimethoprim
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POLYMYXIN B SULFATE10000 [USP'U]/mL
TRIMETHOPRIM SULFATE1 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii19371312D4, E377MF8EQ8
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
68788-8152-1Polymyxin B Sulfate and Trimethoprim10 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS105
68788-8152-1Polymyxin B Sulfate and Trimethoprim1 in 1 CARTONSOLUTION/ DROPS15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8152-1ML - Milliliter68788-815221e29f57-777e-4c73-9f46-f6918d7e023512022-04-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8152POLYMYXIN B SULFATE AND TRIMETHOPRIM (POLYMYXIN B SULFATE AND TRIMETHOPRIM SULFATE) SOLUTION/ DROPS [PREFERRED PHARMACEUTICALS INC.]3Current NDC, Legacy NDC, 2 package rows20240731_31a7ad1f-3f58-41a0-94f0-36674285bb61.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 SolutionPSN31a7ad1f-3f58-41a0-94f0-36674285bb615
244967polymyxin B 10000 UNT/ML / trimethoprim 1 MG/ML Ophthalmic SolutionSCD31a7ad1f-3f58-41a0-94f0-36674285bb615
244967polymyxin B 10,000 UNT / trimethoprim (as trimethoprim sulfate) 0.1 % Ophthalmic SolutionSY31a7ad1f-3f58-41a0-94f0-36674285bb615
244967polymyxin B 10,000 UNT / trimethoprim 0.1 % Ophthalmic SolutionSY31a7ad1f-3f58-41a0-94f0-36674285bb615
244967Polymyxin B 10000 UNT/ML / TMP 1 MG/ML Ophthalmic SolutionSY31a7ad1f-3f58-41a0-94f0-36674285bb615

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68788-8152-1687888152011 BOTTLE, DROPPER in 1 CARTON (68788-8152-1) / 10 mL in 1 BOTTLE, DROPPER2022-03-140000-00-00NoNoCurrent