POLYMYXIN B SULFATE AND TRIMETHOPRIM

Product NDC
72189-005
11-digit product format
721890005
Labeler code
72189
Product ID
72189-005_8c27962d-62b6-30e6-e053-2a95a90a49c6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
POLYMYXIN B SULFATE AND TRIMETHOPRIM
Dosage form
SOLUTION
Route
OPHTHALMIC
Labeler
Direct_Rx
Application
ANDA065006
Marketing category
ANDA
Marketing start
2019-06-25
Marketing end
0000-00-00
Substance
TRIMETHOPRIM SULFATE; POLYMYXIN B SULFATE
Active strength
1 mg/mL; [USP'U]/mL
Pharmacologic classes
Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA],Polymyxin-class Antibacterial [EPC],Polymyxins [CS]
NDC exclude flag
No
Listing certified through
2020-12-31
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
72189-005-102023-01-30C16284748780-1f386c64a-1a48-0266-e053-dadaa90a7c1aPOLYMYXIN B SULFATE AND TRIMETHOPRIM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72189-005-10POLYMYXIN B SULFATE AND TRIMETHOPRIM1 mL in 1 BOTTLE, DROPPERSOLUTION11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72189-005-10ML - Milliliter72189-0058214607d-3f52-4d0b-bac3-fcc3b15a30a212019-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-005POLYMYXIN B SULFATE AND TRIMETHOPRIM SOLUTION [DIRECT_RX]1Legacy NDC, 1 package rows20190626_8c27962d-62b5-30e6-e053-2a95a90a49c6.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 SolutionPSN8c27962d-62b5-30e6-e053-2a95a90a49c61
244967polymyxin B 10000 UNT/ML / trimethoprim 1 MG/ML Ophthalmic SolutionSCD8c27962d-62b5-30e6-e053-2a95a90a49c61
244967polymyxin B 10,000 UNT / trimethoprim (as trimethoprim sulfate) 0.1 % Ophthalmic SolutionSY8c27962d-62b5-30e6-e053-2a95a90a49c61
244967polymyxin B 10,000 UNT / trimethoprim 0.1 % Ophthalmic SolutionSY8c27962d-62b5-30e6-e053-2a95a90a49c61
244967Polymyxin B 10000 UNT/ML / TMP 1 MG/ML Ophthalmic SolutionSY8c27962d-62b5-30e6-e053-2a95a90a49c61

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72189-005-10721890005101 mL in 1 BOTTLE, DROPPER (72189-005-10) 1 ml2019-06-250000-00-00NoNoCurrent