Tobramycin

Product NDC
52959-108
11-digit product format
529590108
Labeler code
52959
Product ID
52959-108_859bbd86-adb6-433d-8ff5-71a754b306b7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tobramycin
Dosage form
SOLUTION
Route
OPHTHALMIC
Labeler
H.J. Harkins Company, Inc.
Application
ANDA064052
Marketing category
ANDA
Marketing start
1993-11-29
Marketing end
0000-00-00
Substance
TOBRAMYCIN
Active strength
3 mg/mL
Pharmacologic classes
Aminoglycoside Antibacterial [EPC],Aminoglycosides [CS]
NDC exclude flag
E
Listing certified through
2017-12-31
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
52959-108-032019-11-13C16284748780-197449f38-c632-f6ea-e053-dbdaa90aa703Tobramycin Ophthalmic Solution USP, 0.3% (Sterile)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52959-108-03Tobramycin1 in 1 CARTONSOLUTION11
52959-108-03Tobramycin5 mL in 1 BOTTLE, DROPPERSOLUTION51

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52959-108-03ML - Milliliter52959-108cd460314-5d04-4b04-a73c-4a3a2a17502c12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TOBRAMYCINACTIVE INGREDIENTVZ8RRZ51VKTOBRAMYCIN SOLUTION [H.J. HARKINS COMPANY, INC.]1
TOBRAMYCINACTIVE MOIETYVZ8RRZ51VKTOBRAMYCIN SOLUTION [H.J. HARKINS COMPANY, INC.]1
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7TOBRAMYCIN SOLUTION [H.J. HARKINS COMPANY, INC.]1
BORIC ACIDINACTIVE INGREDIENTR57ZHV85D4TOBRAMYCIN SOLUTION [H.J. HARKINS COMPANY, INC.]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XTOBRAMYCIN SOLUTION [H.J. HARKINS COMPANY, INC.]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ITOBRAMYCIN SOLUTION [H.J. HARKINS COMPANY, INC.]1
SODIUM SULFATEINACTIVE INGREDIENT0YPR65R21JTOBRAMYCIN SOLUTION [H.J. HARKINS COMPANY, INC.]1
SULFURIC ACIDINACTIVE INGREDIENTO40UQP6WCFTOBRAMYCIN SOLUTION [H.J. HARKINS COMPANY, INC.]1
TYLOXAPOLINACTIVE INGREDIENTY27PUL9H56TOBRAMYCIN SOLUTION [H.J. HARKINS COMPANY, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RTOBRAMYCIN SOLUTION [H.J. HARKINS COMPANY, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52959-108TOBRAMYCIN SOLUTION [H.J. HARKINS COMPANY, INC.]1Legacy NDC, 2 package rows20120217_86c5ae32-18ab-47b2-91f8-cb0dc289e873.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313415tobramycin 0.3 % Ophthalmic SolutionPSN86c5ae32-18ab-47b2-91f8-cb0dc289e8731
313415tobramycin 3 MG/ML Ophthalmic SolutionSCD86c5ae32-18ab-47b2-91f8-cb0dc289e8731
313415tobramycin 0.3 % Ophthalmic SolutionSY86c5ae32-18ab-47b2-91f8-cb0dc289e8731

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
52959-108-03529590108031 in 1 CARTONHistorical