FDA.reportPublic FDA data

Polymyxin B Sulfate and Trimethoprim

Product NDC
24208-315
11-digit product format
242080315
Labeler code
24208
Product ID
24208-315_4732077c-74ed-5e9a-e063-6294a90a6315
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Polymyxin B Sulfate and Trimethoprim Sulfate
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Bausch & Lomb Incorporated
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
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
24208-315-10Polymyxin B Sulfate and Trimethoprim10 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS1013
24208-315-10Polymyxin B Sulfate and Trimethoprim1 in 1 CARTONSOLUTION/ DROPS113

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24208-315POLYMYXIN B SULFATE AND TRIMETHOPRIM (POLYMYXIN B SULFATE AND TRIMETHOPRIM SULFATE) SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]12Current NDC, Legacy NDC, 2 package rows20240208_87999254-1857-4d3c-817a-cb8f6a5b0cf7.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 SolutionPSN87999254-1857-4d3c-817a-cb8f6a5b0cf713
244967polymyxin B 10000 UNT/ML / trimethoprim 1 MG/ML Ophthalmic SolutionSCD87999254-1857-4d3c-817a-cb8f6a5b0cf713
244967polymyxin B 10,000 UNT / trimethoprim (as trimethoprim sulfate) 0.1 % Ophthalmic SolutionSY87999254-1857-4d3c-817a-cb8f6a5b0cf713
244967polymyxin B 10,000 UNT / trimethoprim 0.1 % Ophthalmic SolutionSY87999254-1857-4d3c-817a-cb8f6a5b0cf713
244967Polymyxin B 10000 UNT/ML / TMP 1 MG/ML Ophthalmic SolutionSY87999254-1857-4d3c-817a-cb8f6a5b0cf713
244967polymyxin B sulfate 10,000 UNT / trimethoprim sulfate 1 MG in ML Ophthalmic SolutionPSN31a7ad1f-3f58-41a0-94f0-36674285bb615
244967polymyxin B sulfate 10,000 UNT / trimethoprim sulfate 1 MG in ML Ophthalmic SolutionPSNd1f55327-156f-44cd-b0fc-b1a938e8aa735
244967polymyxin B sulfate 10,000 UNT / trimethoprim sulfate 1 MG in ML Ophthalmic SolutionPSN565bc07b-01fd-4931-8c9e-a07e901a3f8a5
244967polymyxin B sulfate 10,000 UNT / trimethoprim sulfate 1 MG in ML Ophthalmic SolutionPSN55e1f68a-836b-5c23-e054-00144ff88e885
244967polymyxin B 10000 UNT/ML / trimethoprim 1 MG/ML Ophthalmic SolutionSCDd1f55327-156f-44cd-b0fc-b1a938e8aa735
244967polymyxin B 10000 UNT/ML / trimethoprim 1 MG/ML Ophthalmic SolutionSCD565bc07b-01fd-4931-8c9e-a07e901a3f8a5
244967polymyxin B 10000 UNT/ML / trimethoprim 1 MG/ML Ophthalmic SolutionSCD55e1f68a-836b-5c23-e054-00144ff88e885
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 (as trimethoprim sulfate) 0.1 % Ophthalmic SolutionSY55e1f68a-836b-5c23-e054-00144ff88e885
244967polymyxin B 10,000 UNT / trimethoprim (as trimethoprim sulfate) 0.1 % Ophthalmic SolutionSYd1f55327-156f-44cd-b0fc-b1a938e8aa735
244967polymyxin B 10,000 UNT / trimethoprim (as trimethoprim sulfate) 0.1 % Ophthalmic SolutionSY565bc07b-01fd-4931-8c9e-a07e901a3f8a5
244967polymyxin B 10,000 UNT / trimethoprim 0.1 % Ophthalmic SolutionSY55e1f68a-836b-5c23-e054-00144ff88e885
244967polymyxin B 10,000 UNT / trimethoprim 0.1 % Ophthalmic SolutionSYd1f55327-156f-44cd-b0fc-b1a938e8aa735
244967polymyxin B 10,000 UNT / trimethoprim 0.1 % Ophthalmic SolutionSY31a7ad1f-3f58-41a0-94f0-36674285bb615
244967polymyxin B 10,000 UNT / trimethoprim 0.1 % Ophthalmic SolutionSY565bc07b-01fd-4931-8c9e-a07e901a3f8a5
244967Polymyxin B 10000 UNT/ML / TMP 1 MG/ML Ophthalmic SolutionSY55e1f68a-836b-5c23-e054-00144ff88e885
244967Polymyxin B 10000 UNT/ML / TMP 1 MG/ML Ophthalmic SolutionSYd1f55327-156f-44cd-b0fc-b1a938e8aa735
244967Polymyxin B 10000 UNT/ML / TMP 1 MG/ML Ophthalmic SolutionSY565bc07b-01fd-4931-8c9e-a07e901a3f8a5
244967Polymyxin B 10000 UNT/ML / TMP 1 MG/ML Ophthalmic SolutionSY31a7ad1f-3f58-41a0-94f0-36674285bb615
244967polymyxin B sulfate 10,000 UNT / trimethoprim sulfate 1 MG in ML Ophthalmic SolutionPSN7e5bbaef-78a3-4364-ad27-6a8536942ac43
244967polymyxin B 10000 UNT/ML / trimethoprim 1 MG/ML Ophthalmic SolutionSCD7e5bbaef-78a3-4364-ad27-6a8536942ac43
244967polymyxin B 10,000 UNT / trimethoprim (as trimethoprim sulfate) 0.1 % Ophthalmic SolutionSY7e5bbaef-78a3-4364-ad27-6a8536942ac43
244967polymyxin B 10,000 UNT / trimethoprim 0.1 % Ophthalmic SolutionSY7e5bbaef-78a3-4364-ad27-6a8536942ac43
244967Polymyxin B 10000 UNT/ML / TMP 1 MG/ML Ophthalmic SolutionSY7e5bbaef-78a3-4364-ad27-6a8536942ac43
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
244967polymyxin B sulfate 10,000 UNT / trimethoprim sulfate 1 MG in ML Ophthalmic SolutionPSN476b8c6d-44e2-47e3-a75c-b4328dfe82a11
244967polymyxin B 10000 UNT/ML / trimethoprim 1 MG/ML Ophthalmic SolutionSCD476b8c6d-44e2-47e3-a75c-b4328dfe82a11
244967polymyxin B 10,000 UNT / trimethoprim (as trimethoprim sulfate) 0.1 % Ophthalmic SolutionSY476b8c6d-44e2-47e3-a75c-b4328dfe82a11
244967polymyxin B 10,000 UNT / trimethoprim 0.1 % Ophthalmic SolutionSY476b8c6d-44e2-47e3-a75c-b4328dfe82a11
244967Polymyxin B 10000 UNT/ML / TMP 1 MG/ML Ophthalmic SolutionSY476b8c6d-44e2-47e3-a75c-b4328dfe82a11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
24208-315-10242080315101 BOTTLE, DROPPER in 1 CARTON (24208-315-10) / 10 mL in 1 BOTTLE, DROPPER1997-02-140000-00-00NoNoCurrent