FDA.reportPublic FDA data

Polymyxin B Sulfate and Trimethoprim

Product NDC
63187-631
11-digit product format
631870631
Labeler code
63187
Product ID
63187-631_38978a23-dfcb-4930-96a7-15f42fe54e56
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Polymyxin B Sulfate and Trimethoprim Sulfate
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Proficient Rx LP
Application
ANDA064120
Marketing category
ANDA
Marketing start
1997-02-14
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Polymyxin B Sulfate and Trimethoprim
Listing expiration
2026-12-31

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
63187-631-10Polymyxin B Sulfate and Trimethoprim1 in 1 CARTONSOLUTION/ DROPS15
63187-631-10Polymyxin B Sulfate and Trimethoprim10 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS105

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-631-10ML - Milliliter63187-63133097cc4-cf97-4e5e-bff6-cbb39f1fb8f812025-10-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-631POLYMYXIN B SULFATE AND TRIMETHOPRIM (POLYMYXIN B SULFATE AND TRIMETHOPRIM SULFATE) SOLUTION/ DROPS [PROFICIENT RX LP]5Current NDC, Legacy NDC, 2 package rows20220421_d1f55327-156f-44cd-b0fc-b1a938e8aa73.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 SolutionPSNd1f55327-156f-44cd-b0fc-b1a938e8aa735
244967polymyxin B 10000 UNT/ML / trimethoprim 1 MG/ML Ophthalmic SolutionSCDd1f55327-156f-44cd-b0fc-b1a938e8aa735
244967polymyxin B 10,000 UNT / trimethoprim (as trimethoprim sulfate) 0.1 % Ophthalmic SolutionSYd1f55327-156f-44cd-b0fc-b1a938e8aa735
244967polymyxin B 10,000 UNT / trimethoprim 0.1 % Ophthalmic SolutionSYd1f55327-156f-44cd-b0fc-b1a938e8aa735
244967Polymyxin B 10000 UNT/ML / TMP 1 MG/ML Ophthalmic SolutionSYd1f55327-156f-44cd-b0fc-b1a938e8aa735

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63187-631-10631870631101 BOTTLE, DROPPER in 1 CARTON (63187-631-10) / 10 mL in 1 BOTTLE, DROPPER2018-12-010000-00-00NoNoCurrent