FDA.reportPublic FDA data

TOBRAMYCIN AND DEXAMETHASONE

Product NDC
0574-4031
11-digit product format
005744031
Labeler code
0574
Product ID
0574-4031_7c012e78-01c6-4b9a-a971-62a64fe6885a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tobramycin and dexamethasone
Dosage form
SUSPENSION/ DROPS
Route
OPHTHALMIC
Labeler
Padagis US LLC
Application
ANDA212715
Marketing category
ANDA
Marketing start
2022-03-17
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
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
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
0574-4031-05TOBRAMYCIN AND DEXAMETHASONE5 mL in 1 BOTTLE, PLASTICSUSPENSION/ DROPS53
0574-4031-10TOBRAMYCIN AND DEXAMETHASONE10 mL in 1 BOTTLE, PLASTICSUSPENSION/ DROPS103
0574-4031-25TOBRAMYCIN AND DEXAMETHASONE2.5 mL in 1 BOTTLE, PLASTICSUSPENSION/ DROPS2.53

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0574-4031-05ML - Milliliter0574-4031e11d7911-ce6d-4d94-b250-a211263f45fa12022-04-06
0574-4031-10ML - Milliliter0574-40312b55225f-a879-4133-802d-53af6bc0fb6712022-04-06
0574-4031-25ML - Milliliter0574-40319a46a12c-d2a3-45d5-8a09-5be141cff5d812022-04-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0574-4031TOBRAMYCIN AND DEXAMETHASONE SUSPENSION/ DROPS [PADAGIS US LLC]3Current NDC, Legacy NDC, 3 package rows20240327_7e34b1a9-8d21-41db-9070-37227975414f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309683tobramycin 0.3 % / dexAMETHasone 0.1 % Ophthalmic SuspensionPSNa5f0b05b-3dec-4fe8-8106-e41e668a512d103
309683tobramycin 0.3 % / dexAMETHasone 0.1 % Ophthalmic SuspensionPSN1884ef6f-a60c-4a82-a7dc-fd48b7176db0103
309683tobramycin 0.3 % / dexAMETHasone 0.1 % Ophthalmic SuspensionPSN3c63c481-ce57-41ca-993f-5a5b665fa1e4103
309683dexamethasone 1 MG/ML / tobramycin 3 MG/ML Ophthalmic SuspensionSCDa5f0b05b-3dec-4fe8-8106-e41e668a512d103
309683dexamethasone 1 MG/ML / tobramycin 3 MG/ML Ophthalmic SuspensionSCD1884ef6f-a60c-4a82-a7dc-fd48b7176db0103
309683dexamethasone 1 MG/ML / tobramycin 3 MG/ML Ophthalmic SuspensionSCD3c63c481-ce57-41ca-993f-5a5b665fa1e4103
309683dexamethasone 0.1 % / tobramycin 0.3 % Ophthalmic SuspensionSY1884ef6f-a60c-4a82-a7dc-fd48b7176db0103
309683dexamethasone 0.1 % / tobramycin 0.3 % Ophthalmic SuspensionSY3c63c481-ce57-41ca-993f-5a5b665fa1e4103
309683dexamethasone 0.1 % / tobramycin 0.3 % Ophthalmic SuspensionSYa5f0b05b-3dec-4fe8-8106-e41e668a512d103
309683tobramycin 0.3 % / dexAMETHasone 0.1 % Ophthalmic SuspensionPSNdf4a7747-8dfa-4933-b4d2-a3d85c5f74f8102
309683dexamethasone 1 MG/ML / tobramycin 3 MG/ML Ophthalmic SuspensionSCDdf4a7747-8dfa-4933-b4d2-a3d85c5f74f8102
309683dexamethasone 0.1 % / tobramycin 0.3 % Ophthalmic SuspensionSYdf4a7747-8dfa-4933-b4d2-a3d85c5f74f8102
309683tobramycin 0.3 % / dexAMETHasone 0.1 % Ophthalmic SuspensionPSN3e541ebf-2f7e-4cc0-9928-780353aa7657101
309683dexamethasone 1 MG/ML / tobramycin 3 MG/ML Ophthalmic SuspensionSCD3e541ebf-2f7e-4cc0-9928-780353aa7657101
309683dexamethasone 0.1 % / tobramycin 0.3 % Ophthalmic SuspensionSY3e541ebf-2f7e-4cc0-9928-780353aa7657101
309683tobramycin 0.3 % / dexAMETHasone 0.1 % Ophthalmic SuspensionPSN3e5cd7f9-1f88-4d33-be25-c362de4dc87b100
309683tobramycin 0.3 % / dexAMETHasone 0.1 % Ophthalmic SuspensionPSN15280680-edc0-4e5d-99ee-117a6f589307100
309683dexamethasone 1 MG/ML / tobramycin 3 MG/ML Ophthalmic SuspensionSCD3e5cd7f9-1f88-4d33-be25-c362de4dc87b100
309683dexamethasone 1 MG/ML / tobramycin 3 MG/ML Ophthalmic SuspensionSCD15280680-edc0-4e5d-99ee-117a6f589307100
309683dexamethasone 0.1 % / tobramycin 0.3 % Ophthalmic SuspensionSY3e5cd7f9-1f88-4d33-be25-c362de4dc87b100
309683dexamethasone 0.1 % / tobramycin 0.3 % Ophthalmic SuspensionSY15280680-edc0-4e5d-99ee-117a6f589307100
309683tobramycin 0.3 % / dexAMETHasone 0.1 % Ophthalmic SuspensionPSN7e34b1a9-8d21-41db-9070-37227975414f3
309683dexamethasone 1 MG/ML / tobramycin 3 MG/ML Ophthalmic SuspensionSCD7e34b1a9-8d21-41db-9070-37227975414f3
309683dexamethasone 0.1 % / tobramycin 0.3 % Ophthalmic SuspensionSY7e34b1a9-8d21-41db-9070-37227975414f3
309683tobramycin 0.3 % / dexAMETHasone 0.1 % Ophthalmic SuspensionPSN3dd00c21-ae42-0613-e063-6394a90a80122
309683tobramycin 0.3 % / dexAMETHasone 0.1 % Ophthalmic SuspensionPSNf4c00d9c-3a17-06a0-e053-2a95a90a84132
309683dexamethasone 1 MG/ML / tobramycin 3 MG/ML Ophthalmic SuspensionSCD3dd00c21-ae42-0613-e063-6394a90a80122
309683dexamethasone 1 MG/ML / tobramycin 3 MG/ML Ophthalmic SuspensionSCDf4c00d9c-3a17-06a0-e053-2a95a90a84132
309683dexamethasone 0.1 % / tobramycin 0.3 % Ophthalmic SuspensionSY3dd00c21-ae42-0613-e063-6394a90a80122
309683dexamethasone 0.1 % / tobramycin 0.3 % Ophthalmic SuspensionSYf4c00d9c-3a17-06a0-e053-2a95a90a84132
309683tobramycin 0.3 % / dexAMETHasone 0.1 % Ophthalmic SuspensionPSN8d6a8a22-fd97-43e7-a89c-b1f32710a7731
309683tobramycin 0.3 % / dexAMETHasone 0.1 % Ophthalmic SuspensionPSNe236d98c-128e-b2f7-e053-2a95a90a74221
309683dexamethasone 1 MG/ML / tobramycin 3 MG/ML Ophthalmic SuspensionSCD8d6a8a22-fd97-43e7-a89c-b1f32710a7731
309683dexamethasone 1 MG/ML / tobramycin 3 MG/ML Ophthalmic SuspensionSCDe236d98c-128e-b2f7-e053-2a95a90a74221
309683dexamethasone 0.1 % / tobramycin 0.3 % Ophthalmic SuspensionSY8d6a8a22-fd97-43e7-a89c-b1f32710a7731
309683dexamethasone 0.1 % / tobramycin 0.3 % Ophthalmic SuspensionSYe236d98c-128e-b2f7-e053-2a95a90a74221

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0574-4031-05005744031055 mL in 1 BOTTLE, PLASTIC (0574-4031-05) 5 ml2022-03-170000-00-00NoNoCurrent
0574-4031-100057440311010 mL in 1 BOTTLE, PLASTIC (0574-4031-10) 10 ml2022-03-170000-00-00NoNoCurrent
0574-4031-25005744031252.5 mL in 1 BOTTLE, PLASTIC (0574-4031-25) 2.5 ml2022-03-170000-00-00NoNoCurrent