Tobramycin

Product NDC
33261-519
11-digit product format
332610519
Labeler code
33261
Product ID
33261-519_95c267a5-1ade-416e-bafe-c358d343e10c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tobramycin
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA064096
Marketing category
ANDA
Marketing start
2018-01-18
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
2019-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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
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
33261-519-012020-01-31C16284748780-19d75b9cf-df76-f424-e053-dadaa90a57ceTobramycin Ophthalmic Solution, USP 0.3%–Sterile

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33261-519-01Tobramycin5 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS51

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33261-519TOBRAMYCIN SOLUTION/ DROPS [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 1 package rows20180820_73119111-c8a5-4415-83ad-2ccde56590b0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313415tobramycin 0.3 % Ophthalmic SolutionPSN73119111-c8a5-4415-83ad-2ccde56590b01
313415tobramycin 3 MG/ML Ophthalmic SolutionSCD73119111-c8a5-4415-83ad-2ccde56590b01
313415tobramycin 0.3 % Ophthalmic SolutionSY73119111-c8a5-4415-83ad-2ccde56590b01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
33261-519-01332610519015 mL in 1 BOTTLE, DROPPER5 mlHistorical