FDA.reportPublic FDA data

Tobramycin and Dexamethasone

Product NDC
52959-984
11-digit product format
529590984
Labeler code
52959
Product ID
52959-984_fb0e30f7-a594-40cf-b56c-a45cfbcd60d8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tobramycin and Dexamethasone
Dosage form
SUSPENSION
Route
OPHTHALMIC
Labeler
H.J. Harkins Company, Inc.
Application
NDA050592
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2009-01-02
Marketing end
0000-00-00
Substance
TOBRAMYCIN; DEXAMETHASONE
Active strength
3 mg/mL; mg/mL
Pharmacologic classes
Aminoglycoside Antibacterial [EPC],Aminoglycosides [CS],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
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
1ea46721-9071-6b81-fd0a-a82bfbb014ecProduct name720250220
525701df-f985-480d-995a-e0ee70c2bdf4Product name520250128
f297c7c1-845a-4369-8c02-c51b92d6ae8eProduct name320240725
ea50b939-d92a-4100-84f5-1c1089663837Product name220240705
551d952d-4ce2-24f0-9ab0-630ad9aae596Product name220231211
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
941f67d9-7f03-56d2-750c-36de24f654dbProduct name320221117
d7d46a10-8766-d3c8-ebf2-2ccd9efdcae8Product name220220506
7b2c58e8-5850-4e3e-82e9-b1593b1de761Product name520220210
9cfa145f-dbe9-bc02-83c2-692786ef6676Product name920210928
2f9713b8-5e7e-bbcc-b364-1b2c27a63796Product name420210903
32a533bc-01c7-2b9f-bbf7-ecfb0d964277Product name420210625
81e34474-b0a5-434f-8104-25d689efc99eProduct name120200303
05ab9c01-cd9a-4f59-b2e8-ddcb887cac39Product name120190408
0c7dba41-c919-5809-508d-4affe6cfcff2Product name220170817
9f5124fb-08b0-4c3e-8e12-a1a6ff310cbaProduct name120150309
399647c0-db89-02d1-991c-0c17b584482cProduct name120140508
3e9a6377-704f-dff7-b19f-56c98d40c444Product name120140508
4d2e6ff9-14f5-b84f-c39b-373b005712c1Product name120140508
725d71bf-f956-5cad-e556-fa39cb060dc8Product name120140508
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
52959-984-052019-11-13C16284748780-197449f38-cd13-f6ea-e053-dbdaa90aa703Tobramycin and Dexamethasone Ophthalmic Suspension Sterile
52959-984-102019-11-13C16284748780-197449f38-cd13-f6ea-e053-dbdaa90aa703Tobramycin and Dexamethasone Ophthalmic Suspension Sterile

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52959-984-05Tobramycin and Dexamethasone5 mL in 1 BOTTLESUSPENSION52
52959-984-10Tobramycin and Dexamethasone10 mL in 1 BOTTLESUSPENSION102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52959-984-10ML - Milliliter52959-984c61fb745-7464-469b-b1c3-d1074f96ab4112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXAMETHASONEACTIVE INGREDIENT7S5I7G3JQLTOBRAMYCIN AND DEXAMETHASONE SUSPENSION [H.J. HARKINS COMPANY, INC.]2
TOBRAMYCINACTIVE INGREDIENTVZ8RRZ51VKTOBRAMYCIN AND DEXAMETHASONE SUSPENSION [H.J. HARKINS COMPANY, INC.]2
DEXAMETHASONEACTIVE MOIETY7S5I7G3JQLTOBRAMYCIN AND DEXAMETHASONE SUSPENSION [H.J. HARKINS COMPANY, INC.]2
TOBRAMYCINACTIVE MOIETYVZ8RRZ51VKTOBRAMYCIN AND DEXAMETHASONE SUSPENSION [H.J. HARKINS COMPANY, INC.]2
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7TOBRAMYCIN AND DEXAMETHASONE SUSPENSION [H.J. HARKINS COMPANY, INC.]2
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KTOBRAMYCIN AND DEXAMETHASONE SUSPENSION [H.J. HARKINS COMPANY, INC.]2
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)INACTIVE INGREDIENTS38J6RZN16TOBRAMYCIN AND DEXAMETHASONE SUSPENSION [H.J. HARKINS COMPANY, INC.]2
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XTOBRAMYCIN AND DEXAMETHASONE SUSPENSION [H.J. HARKINS COMPANY, INC.]2
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ITOBRAMYCIN AND DEXAMETHASONE SUSPENSION [H.J. HARKINS COMPANY, INC.]2
SODIUM SULFATEINACTIVE INGREDIENT0YPR65R21JTOBRAMYCIN AND DEXAMETHASONE SUSPENSION [H.J. HARKINS COMPANY, INC.]2
SULFURIC ACIDINACTIVE INGREDIENTO40UQP6WCFTOBRAMYCIN AND DEXAMETHASONE SUSPENSION [H.J. HARKINS COMPANY, INC.]2
TYLOXAPOLINACTIVE INGREDIENTY27PUL9H56TOBRAMYCIN AND DEXAMETHASONE SUSPENSION [H.J. HARKINS COMPANY, INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RTOBRAMYCIN AND DEXAMETHASONE SUSPENSION [H.J. HARKINS COMPANY, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52959-984TOBRAMYCIN AND DEXAMETHASONE SUSPENSION [H.J. HARKINS COMPANY, INC.]2Legacy NDC, 2 package rows20111215_8f7f1b78-8ac3-4ba5-b0ec-ca87a433ad39.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309683tobramycin 0.3 % / dexAMETHasone 0.1 % Ophthalmic SuspensionPSN8f7f1b78-8ac3-4ba5-b0ec-ca87a433ad392
309683dexamethasone 1 MG/ML / tobramycin 3 MG/ML Ophthalmic SuspensionSCD8f7f1b78-8ac3-4ba5-b0ec-ca87a433ad392
309683dexamethasone 0.1 % / tobramycin 0.3 % Ophthalmic SuspensionSY8f7f1b78-8ac3-4ba5-b0ec-ca87a433ad392

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
52959-984-05529590984055 mL in 1 BOTTLE5 mlHistorical
52959-984-105295909841010 mL in 1 BOTTLE10 mlHistorical