FDA.reportPublic FDA data

Tobramycin and Dexamethasone

Product NDC
61314-647
11-digit product format
613140647
Labeler code
61314
Product ID
61314-647_e7d4aa10-eff7-4523-9fa2-a60e19e8dee2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tobramycin and Dexamethasone
Dosage form
SUSPENSION/ DROPS
Route
OPHTHALMIC
Labeler
Sandoz Inc
Application
NDA050592
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2009-01-02
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
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ea50b939-d92a-4100-84f5-1c1089663837Product name220240705
551d952d-4ce2-24f0-9ab0-630ad9aae596Product name220231211
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
941f67d9-7f03-56d2-750c-36de24f654dbProduct name320221117
d7d46a10-8766-d3c8-ebf2-2ccd9efdcae8Product name220220506
7b2c58e8-5850-4e3e-82e9-b1593b1de761Product name520220210
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
9cfa145f-dbe9-bc02-83c2-692786ef6676Product name920210928
2f9713b8-5e7e-bbcc-b364-1b2c27a63796Product name420210903
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
32a533bc-01c7-2b9f-bbf7-ecfb0d964277Product name420210625
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
81e34474-b0a5-434f-8104-25d689efc99eProduct name120200303
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
05ab9c01-cd9a-4f59-b2e8-ddcb887cac39Product name120190408
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
0c7dba41-c919-5809-508d-4affe6cfcff2Product name220170817
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
9f5124fb-08b0-4c3e-8e12-a1a6ff310cbaProduct name120150309
399647c0-db89-02d1-991c-0c17b584482cProduct name120140508
3e9a6377-704f-dff7-b19f-56c98d40c444Product name120140508
4d2e6ff9-14f5-b84f-c39b-373b005712c1Product name120140508
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
725d71bf-f956-5cad-e556-fa39cb060dc8Product name120140508
745a62af-e1c0-4ca3-6d6e-2b6455b903beProduct name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
9ea85abb-fa68-5da6-ab60-2c7eef579000Product name120140508
aa1cd319-ece7-51f7-3a9d-52a64f5f4e81Product name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
d029211e-5e6b-725f-3696-ac6ff77da222Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508
ef5b7aed-2b01-3ba8-5a1c-3bc9c9f03bb1Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61314-647-05Tobramycin and Dexamethasone1 in 1 CARTONSUSPENSION/ DROPS111
61314-647-05Tobramycin and Dexamethasone5 mL in 1 BOTTLESUSPENSION/ DROPS511
61314-647-10Tobramycin and Dexamethasone10 mL in 1 BOTTLESUSPENSION/ DROPS1011
61314-647-10Tobramycin and Dexamethasone1 in 1 CARTONSUSPENSION/ DROPS111
61314-647-25Tobramycin and Dexamethasone1 in 1 CARTONSUSPENSION/ DROPS111
61314-647-25Tobramycin and Dexamethasone2.5 mL in 1 BOTTLESUSPENSION/ DROPS2.511

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61314-647-05ML - Milliliter61314-647fdd29e7e-274b-45c8-a751-5bd764326d7c12012-07-24
61314-647-10ML - Milliliter61314-647833bf078-c743-4df2-b06a-f230991f6aa412012-07-24
61314-647-25ML - Milliliter61314-647bb07e61f-7025-419a-857f-11a02991f8cf12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXAMETHASONEACTIVE INGREDIENT7S5I7G3JQLTOBRAMYCIN AND DEXAMETHASONE (TOBRAMYCIN AND DEXAMETHASONE) SUSPENSION/ DROPS [SANDOZ INC.]3
TOBRAMYCINACTIVE INGREDIENTVZ8RRZ51VKTOBRAMYCIN AND DEXAMETHASONE (TOBRAMYCIN AND DEXAMETHASONE) SUSPENSION/ DROPS [SANDOZ INC.]3
DEXAMETHASONEACTIVE MOIETY7S5I7G3JQLTOBRAMYCIN AND DEXAMETHASONE (TOBRAMYCIN AND DEXAMETHASONE) SUSPENSION/ DROPS [SANDOZ INC.]3
TOBRAMYCINACTIVE MOIETYVZ8RRZ51VKTOBRAMYCIN AND DEXAMETHASONE (TOBRAMYCIN AND DEXAMETHASONE) SUSPENSION/ DROPS [SANDOZ INC.]3
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7TOBRAMYCIN AND DEXAMETHASONE (TOBRAMYCIN AND DEXAMETHASONE) SUSPENSION/ DROPS [SANDOZ INC.]3
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KTOBRAMYCIN AND DEXAMETHASONE (TOBRAMYCIN AND DEXAMETHASONE) SUSPENSION/ DROPS [SANDOZ INC.]3
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)INACTIVE INGREDIENTS38J6RZN16TOBRAMYCIN AND DEXAMETHASONE (TOBRAMYCIN AND DEXAMETHASONE) SUSPENSION/ DROPS [SANDOZ INC.]3
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XTOBRAMYCIN AND DEXAMETHASONE (TOBRAMYCIN AND DEXAMETHASONE) SUSPENSION/ DROPS [SANDOZ INC.]3
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ITOBRAMYCIN AND DEXAMETHASONE (TOBRAMYCIN AND DEXAMETHASONE) SUSPENSION/ DROPS [SANDOZ INC.]3
SODIUM SULFATEINACTIVE INGREDIENT0YPR65R21JTOBRAMYCIN AND DEXAMETHASONE (TOBRAMYCIN AND DEXAMETHASONE) SUSPENSION/ DROPS [SANDOZ INC.]3
SULFURIC ACIDINACTIVE INGREDIENTO40UQP6WCFTOBRAMYCIN AND DEXAMETHASONE (TOBRAMYCIN AND DEXAMETHASONE) SUSPENSION/ DROPS [SANDOZ INC.]3
TYLOXAPOLINACTIVE INGREDIENTY27PUL9H56TOBRAMYCIN AND DEXAMETHASONE (TOBRAMYCIN AND DEXAMETHASONE) SUSPENSION/ DROPS [SANDOZ INC.]3
WATERINACTIVE INGREDIENT059QF0KO0RTOBRAMYCIN AND DEXAMETHASONE (TOBRAMYCIN AND DEXAMETHASONE) SUSPENSION/ DROPS [SANDOZ INC.]3
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
DEXAMETHASONEACTIVE INGREDIENT7S5I7G3JQLTOBRAMYCIN AND DEXAMETHASONE SUSPENSION/ DROPS [REBEL DISTRIBUTORS CORP]1
TOBRAMYCINACTIVE INGREDIENTVZ8RRZ51VKTOBRAMYCIN AND DEXAMETHASONE SUSPENSION/ DROPS [REBEL DISTRIBUTORS CORP]1
DEXAMETHASONEACTIVE MOIETY7S5I7G3JQLTOBRAMYCIN AND DEXAMETHASONE SUSPENSION/ DROPS [REBEL DISTRIBUTORS CORP]1
TOBRAMYCINACTIVE MOIETYVZ8RRZ51VKTOBRAMYCIN AND DEXAMETHASONE SUSPENSION/ DROPS [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61314-647TOBRAMYCIN AND DEXAMETHASONE SUSPENSION/ DROPS [SANDOZ INC]10Current NDC, Legacy NDC, 6 package rows20250423_05fd0c36-39b4-4a43-8490-eb8dfc0920ae.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309683tobramycin 0.3 % / dexAMETHasone 0.1 % Ophthalmic SuspensionPSN05fd0c36-39b4-4a43-8490-eb8dfc0920ae11
309683tobramycin 0.3 % / dexAMETHasone 0.1 % Ophthalmic SuspensionPSNe4ddce2f-1b91-46e1-a8f0-a38394d4e67211
309683dexamethasone 1 MG/ML / tobramycin 3 MG/ML Ophthalmic SuspensionSCD05fd0c36-39b4-4a43-8490-eb8dfc0920ae11
309683dexamethasone 1 MG/ML / tobramycin 3 MG/ML Ophthalmic SuspensionSCDe4ddce2f-1b91-46e1-a8f0-a38394d4e67211
309683dexamethasone 0.1 % / tobramycin 0.3 % Ophthalmic SuspensionSY05fd0c36-39b4-4a43-8490-eb8dfc0920ae11
309683dexamethasone 0.1 % / tobramycin 0.3 % Ophthalmic SuspensionSYe4ddce2f-1b91-46e1-a8f0-a38394d4e67211
309683tobramycin 0.3 % / dexAMETHasone 0.1 % Ophthalmic SuspensionPSN11c2ba9a-7aa3-4f78-aa2f-2a35d26716817
309683dexamethasone 1 MG/ML / tobramycin 3 MG/ML Ophthalmic SuspensionSCD11c2ba9a-7aa3-4f78-aa2f-2a35d26716817
309683dexamethasone 0.1 % / tobramycin 0.3 % Ophthalmic SuspensionSY11c2ba9a-7aa3-4f78-aa2f-2a35d26716817
309683tobramycin 0.3 % / dexAMETHasone 0.1 % Ophthalmic SuspensionPSNc606945c-4ffc-4ee8-af04-a00de8ea92594
309683dexamethasone 1 MG/ML / tobramycin 3 MG/ML Ophthalmic SuspensionSCDc606945c-4ffc-4ee8-af04-a00de8ea92594
309683dexamethasone 0.1 % / tobramycin 0.3 % Ophthalmic SuspensionSYc606945c-4ffc-4ee8-af04-a00de8ea92594
309683tobramycin 0.3 % / dexAMETHasone 0.1 % Ophthalmic SuspensionPSN09315f0b-f15a-30d5-e063-6394a90ac8dd2
309683tobramycin 0.3 % / dexAMETHasone 0.1 % Ophthalmic SuspensionPSN8f7f1b78-8ac3-4ba5-b0ec-ca87a433ad392
309683dexamethasone 1 MG/ML / tobramycin 3 MG/ML Ophthalmic SuspensionSCD09315f0b-f15a-30d5-e063-6394a90ac8dd2
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
309683dexamethasone 0.1 % / tobramycin 0.3 % Ophthalmic SuspensionSY09315f0b-f15a-30d5-e063-6394a90ac8dd2
309683tobramycin 0.3 % / dexAMETHasone 0.1 % Ophthalmic SuspensionPSN8a143864-e36b-49bf-91b4-c6cc1a9280311
309683tobramycin 0.3 % / dexAMETHasone 0.1 % Ophthalmic SuspensionPSN5dda7621-5438-4522-8be0-bc2e8dc418c51
309683tobramycin 0.3 % / dexAMETHasone 0.1 % Ophthalmic SuspensionPSN238bec79-88cf-ae9f-e063-6394a90aaf1c1
309683dexamethasone 1 MG/ML / tobramycin 3 MG/ML Ophthalmic SuspensionSCD8a143864-e36b-49bf-91b4-c6cc1a9280311
309683dexamethasone 1 MG/ML / tobramycin 3 MG/ML Ophthalmic SuspensionSCD5dda7621-5438-4522-8be0-bc2e8dc418c51
309683dexamethasone 1 MG/ML / tobramycin 3 MG/ML Ophthalmic SuspensionSCD238bec79-88cf-ae9f-e063-6394a90aaf1c1
309683dexamethasone 0.1 % / tobramycin 0.3 % Ophthalmic SuspensionSY8a143864-e36b-49bf-91b4-c6cc1a9280311
309683dexamethasone 0.1 % / tobramycin 0.3 % Ophthalmic SuspensionSY5dda7621-5438-4522-8be0-bc2e8dc418c51
309683dexamethasone 0.1 % / tobramycin 0.3 % Ophthalmic SuspensionSY238bec79-88cf-ae9f-e063-6394a90aaf1c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61314-647-05613140647051 BOTTLE in 1 CARTON (61314-647-05) / 5 mL in 1 BOTTLE1 bottle2015-01-020000-00-00NoNoCurrent
61314-647-10613140647101 BOTTLE in 1 CARTON (61314-647-10) / 10 mL in 1 BOTTLE1 bottle2009-01-020000-00-00NoNoCurrent
61314-647-25613140647251 BOTTLE in 1 CARTON (61314-647-25) / 2.5 mL in 1 BOTTLE1 bottle2009-01-020000-00-00NoNoCurrent