Tobramycin

Product NDC
45865-119
11-digit product format
458650119
Labeler code
45865
Product ID
45865-119_b37ce61e-5c75-0ac2-e053-2a95a90a318e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tobramycin
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Medsource Pharmaceuticals
Application
ANDA207444
Marketing category
ANDA
Marketing start
2017-06-28
Marketing end
0000-00-00
Substance
TOBRAMYCIN
Active strength
3 mg/mL
Pharmacologic classes
Aminoglycoside Antibacterial [EPC],Aminoglycosides [CS]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
95250459-30e4-45c1-b08a-993044f49109Product name220250805
f297c7c1-845a-4369-8c02-c51b92d6ae8eProduct name320240725
551d952d-4ce2-24f0-9ab0-630ad9aae596Product name220231211
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
941f67d9-7f03-56d2-750c-36de24f654dbProduct name320221117
9cfa145f-dbe9-bc02-83c2-692786ef6676Product name920210928
2f9713b8-5e7e-bbcc-b364-1b2c27a63796Product name420210903
32a533bc-01c7-2b9f-bbf7-ecfb0d964277Product name420210625
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
9f5124fb-08b0-4c3e-8e12-a1a6ff310cbaProduct name120150309
745a62af-e1c0-4ca3-6d6e-2b6455b903beProduct name120140508
9ea85abb-fa68-5da6-ab60-2c7eef579000Product name120140508
aa1cd319-ece7-51f7-3a9d-52a64f5f4e81Product name120140508
d029211e-5e6b-725f-3696-ac6ff77da222Product name120140508
ef5b7aed-2b01-3ba8-5a1c-3bc9c9f03bb1Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
45865-119-012025-01-30C16284748780-12cef2736-5fd6-d83d-e063-dadaa90ab31fRx Only For Topical Ophthalmic Use Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45865-119-01Tobramycin5 mL in 1 BOTTLESOLUTION/ DROPS51

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45865-119TOBRAMYCIN SOLUTION/ DROPS [MEDSOURCE PHARMACEUTICALS]1Legacy NDC, 1 package rows20201107_b37ce61e-5c74-0ac2-e053-2a95a90a318e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313415tobramycin 0.3 % Ophthalmic SolutionPSNb37ce61e-5c74-0ac2-e053-2a95a90a318e1
313415tobramycin 3 MG/ML Ophthalmic SolutionSCDb37ce61e-5c74-0ac2-e053-2a95a90a318e1
313415tobramycin 0.3 % Ophthalmic SolutionSYb37ce61e-5c74-0ac2-e053-2a95a90a318e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45865-119-01458650119015 mL in 1 BOTTLE (45865-119-01) 5 ml2017-06-280000-00-00NoNoCurrent