FDA.reportPublic FDA data

Tobramycin and Dexamethasone

Product NDC
24208-295
11-digit product format
242080295
Labeler code
24208
Product ID
24208-295_8ef3520d-ac67-4e2d-b0a6-f876e4d1d89f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tobramycin and Dexamethasone
Dosage form
SUSPENSION/ DROPS
Route
OPHTHALMIC
Labeler
Bausch & Lomb Incorporated
Application
ANDA064134
Marketing category
ANDA
Marketing start
1999-10-27
Substance
DEXAMETHASONE; TOBRAMYCIN
Active strength
1; 3 mg/mL; mg/mL
Pharmacologic classes
Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Tobramycin and Dexamethasone
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXAMETHASONE1 mg/mL
TOBRAMYCIN3 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7S5I7G3JQL, VZ8RRZ51VK
Rxcui309683

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
24208-295-05Tobramycin and Dexamethasone1 in 1 CARTONSUSPENSION/ DROPS116
24208-295-05Tobramycin and Dexamethasone5 mL in 1 BOTTLE, DROPPERSUSPENSION/ DROPS516
24208-295-10Tobramycin and Dexamethasone1 in 1 CARTONSUSPENSION/ DROPS116
24208-295-10Tobramycin and Dexamethasone10 mL in 1 BOTTLE, DROPPERSUSPENSION/ DROPS1016
24208-295-25Tobramycin and Dexamethasone1 in 1 CARTONSUSPENSION/ DROPS116
24208-295-25Tobramycin and Dexamethasone2.5 mL in 1 BOTTLE, DROPPERSUSPENSION/ DROPS2.516

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
24208-295-05ML - Milliliter24208-29508e2b41a-f102-4605-9a97-b2a94a57f28112012-07-24
24208-295-10ML - Milliliter24208-295f8da4027-c543-4b27-89bd-b1ea60b6ef9212012-07-24
24208-295-25ML - Milliliter24208-2952a7b3a92-54f1-48e9-b10f-ba5872c4a4cd12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXAMETHASONEACTIVE INGREDIENT7S5I7G3JQLTOBRAMYCIN AND DEXAMETHASONE SUSPENSION/ DROPS [BAUSCH & LOMB INCORPORATED]4
TOBRAMYCINACTIVE INGREDIENTVZ8RRZ51VKTOBRAMYCIN AND DEXAMETHASONE SUSPENSION/ DROPS [BAUSCH & LOMB INCORPORATED]4
DEXAMETHASONEACTIVE MOIETY7S5I7G3JQLTOBRAMYCIN AND DEXAMETHASONE SUSPENSION/ DROPS [BAUSCH & LOMB INCORPORATED]4
TOBRAMYCINACTIVE MOIETYVZ8RRZ51VKTOBRAMYCIN AND DEXAMETHASONE SUSPENSION/ DROPS [BAUSCH & LOMB INCORPORATED]4
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7TOBRAMYCIN AND DEXAMETHASONE SUSPENSION/ DROPS [BAUSCH & LOMB INCORPORATED]4
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KTOBRAMYCIN AND DEXAMETHASONE SUSPENSION/ DROPS [BAUSCH & LOMB INCORPORATED]4
HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)INACTIVE INGREDIENTS38J6RZN16TOBRAMYCIN AND DEXAMETHASONE SUSPENSION/ DROPS [BAUSCH & LOMB INCORPORATED]4
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XTOBRAMYCIN AND DEXAMETHASONE SUSPENSION/ DROPS [BAUSCH & LOMB INCORPORATED]4
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ITOBRAMYCIN AND DEXAMETHASONE SUSPENSION/ DROPS [BAUSCH & LOMB INCORPORATED]4
SODIUM SULFATEINACTIVE INGREDIENT0YPR65R21JTOBRAMYCIN AND DEXAMETHASONE SUSPENSION/ DROPS [BAUSCH & LOMB INCORPORATED]4
SULFURIC ACIDINACTIVE INGREDIENTO40UQP6WCFTOBRAMYCIN AND DEXAMETHASONE SUSPENSION/ DROPS [BAUSCH & LOMB INCORPORATED]4
TYLOXAPOLINACTIVE INGREDIENTY27PUL9H56TOBRAMYCIN AND DEXAMETHASONE SUSPENSION/ DROPS [BAUSCH & LOMB INCORPORATED]4
WATERINACTIVE INGREDIENT059QF0KO0RTOBRAMYCIN AND DEXAMETHASONE SUSPENSION/ DROPS [BAUSCH & LOMB INCORPORATED]4
DEXAMETHASONEACTIVE INGREDIENT7S5I7G3JQLTOBRAMYCIN AND DEXAMETHASONE SUSPENSION/ DROPS [PHYSICIANS TOTAL CARE, INC.]1
TOBRAMYCINACTIVE INGREDIENTVZ8RRZ51VKTOBRAMYCIN AND DEXAMETHASONE SUSPENSION/ DROPS [PHYSICIANS TOTAL CARE, INC.]1
DEXAMETHASONEACTIVE MOIETY7S5I7G3JQLTOBRAMYCIN AND DEXAMETHASONE SUSPENSION/ DROPS [PHYSICIANS TOTAL CARE, INC.]1
TOBRAMYCINACTIVE MOIETYVZ8RRZ51VKTOBRAMYCIN AND DEXAMETHASONE SUSPENSION/ DROPS [PHYSICIANS TOTAL CARE, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24208-295TOBRAMYCIN AND DEXAMETHASONE SUSPENSION/ DROPS [BAUSCH & LOMB INCORPORATED]16Current NDC, Legacy NDC, 6 package rows20231014_33de419e-a89b-47e5-952b-87e837f5d531.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309683tobramycin 0.3 % / dexAMETHasone 0.1 % Ophthalmic SuspensionPSN33de419e-a89b-47e5-952b-87e837f5d53116
309683dexamethasone 1 MG/ML / tobramycin 3 MG/ML Ophthalmic SuspensionSCD33de419e-a89b-47e5-952b-87e837f5d53116
309683dexamethasone 0.1 % / tobramycin 0.3 % Ophthalmic SuspensionSY33de419e-a89b-47e5-952b-87e837f5d53116
309683tobramycin 0.3 % / dexAMETHasone 0.1 % Ophthalmic SuspensionPSNcdd9086d-821f-4ac8-bc49-f1869dffb15013
309683dexamethasone 1 MG/ML / tobramycin 3 MG/ML Ophthalmic SuspensionSCDcdd9086d-821f-4ac8-bc49-f1869dffb15013
309683dexamethasone 0.1 % / tobramycin 0.3 % Ophthalmic SuspensionSYcdd9086d-821f-4ac8-bc49-f1869dffb15013
309683tobramycin 0.3 % / dexAMETHasone 0.1 % Ophthalmic SuspensionPSN61693e79-81d1-3162-e053-2a91aa0ae9254
309683tobramycin 0.3 % / dexAMETHasone 0.1 % Ophthalmic SuspensionPSNb7b39ad5-e158-b8fe-e053-2995a90a52794
309683dexamethasone 1 MG/ML / tobramycin 3 MG/ML Ophthalmic SuspensionSCD61693e79-81d1-3162-e053-2a91aa0ae9254
309683dexamethasone 1 MG/ML / tobramycin 3 MG/ML Ophthalmic SuspensionSCDb7b39ad5-e158-b8fe-e053-2995a90a52794
309683dexamethasone 0.1 % / tobramycin 0.3 % Ophthalmic SuspensionSY61693e79-81d1-3162-e053-2a91aa0ae9254
309683dexamethasone 0.1 % / tobramycin 0.3 % Ophthalmic SuspensionSYb7b39ad5-e158-b8fe-e053-2995a90a52794
309683tobramycin 0.3 % / dexAMETHasone 0.1 % Ophthalmic SuspensionPSNc33e84ba-4c0c-f738-e053-2995a90aa20a2
309683dexamethasone 1 MG/ML / tobramycin 3 MG/ML Ophthalmic SuspensionSCDc33e84ba-4c0c-f738-e053-2995a90aa20a2
309683dexamethasone 0.1 % / tobramycin 0.3 % Ophthalmic SuspensionSYc33e84ba-4c0c-f738-e053-2995a90aa20a2
309683tobramycin 0.3 % / dexAMETHasone 0.1 % Ophthalmic SuspensionPSN0e460787-5413-44d3-bd60-69d3d04f97eb1
309683tobramycin 0.3 % / dexAMETHasone 0.1 % Ophthalmic SuspensionPSN7ed85675-bc46-4dd6-bb8f-7e98c3eb84e21
309683dexamethasone 1 MG/ML / tobramycin 3 MG/ML Ophthalmic SuspensionSCD7ed85675-bc46-4dd6-bb8f-7e98c3eb84e21
309683dexamethasone 1 MG/ML / tobramycin 3 MG/ML Ophthalmic SuspensionSCD0e460787-5413-44d3-bd60-69d3d04f97eb1
309683dexamethasone 0.1 % / tobramycin 0.3 % Ophthalmic SuspensionSY7ed85675-bc46-4dd6-bb8f-7e98c3eb84e21
309683dexamethasone 0.1 % / tobramycin 0.3 % Ophthalmic SuspensionSY0e460787-5413-44d3-bd60-69d3d04f97eb1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
24208-295-05242080295051 BOTTLE, DROPPER in 1 CARTON (24208-295-05) / 5 mL in 1 BOTTLE, DROPPER1999-10-270000-00-00NoNoCurrent
24208-295-10242080295101 BOTTLE, DROPPER in 1 CARTON (24208-295-10) / 10 mL in 1 BOTTLE, DROPPER1999-10-270000-00-00NoNoCurrent
24208-295-25242080295251 BOTTLE, DROPPER in 1 CARTON (24208-295-25) / 2.5 mL in 1 BOTTLE, DROPPER1999-10-270000-00-00NoNoCurrent