FDA.reportPublic FDA data

Tobramycin

Product NDC
70069-131
11-digit product format
700690131
Labeler code
70069
Product ID
70069-131_5632de45-3ada-4ba0-ba39-f973905f7e86
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tobramycin
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Somerset Therapeutics, LLC
Application
ANDA207444
Marketing category
ANDA
Marketing start
2020-08-11
Substance
TOBRAMYCIN
Active strength
3 mg/mL
Pharmacologic classes
Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TOBRAMYCIN3 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiVZ8RRZ51VK
Rxcui313415

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
95250459-30e4-45c1-b08a-993044f49109Product name220250805
f297c7c1-845a-4369-8c02-c51b92d6ae8eProduct name320240725
551d952d-4ce2-24f0-9ab0-630ad9aae596Product name220231211
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
941f67d9-7f03-56d2-750c-36de24f654dbProduct name320221117
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
9cfa145f-dbe9-bc02-83c2-692786ef6676Product name920210928
2f9713b8-5e7e-bbcc-b364-1b2c27a63796Product name420210903
32a533bc-01c7-2b9f-bbf7-ecfb0d964277Product name420210625
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
9f5124fb-08b0-4c3e-8e12-a1a6ff310cbaProduct name120150309
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product 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
70069-131-01Tobramycin1 in 1 CARTONSOLUTION/ DROPS19
70069-131-01Tobramycin5 mL in 1 BOTTLESOLUTION/ DROPS59

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70069-131-01ML - Milliliter70069-131f390149a-e072-4bec-bacb-7c770ce4c85d12017-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70069-131TOBRAMYCIN SOLUTION/ DROPS [SOMERSET THERAPEUTICS, LLC]8Current NDC, Legacy NDC, 2 package rows20230602_7333280d-5d2a-4609-ab93-3ab7031b65db.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313415tobramycin 0.3 % Ophthalmic SolutionPSN3596dacc-6abc-45eb-8085-fa7aaa580a1c13
313415tobramycin 3 MG/ML Ophthalmic SolutionSCD3596dacc-6abc-45eb-8085-fa7aaa580a1c13
313415tobramycin 0.3 % Ophthalmic SolutionSY3596dacc-6abc-45eb-8085-fa7aaa580a1c13
313415tobramycin 0.3 % Ophthalmic SolutionPSN7333280d-5d2a-4609-ab93-3ab7031b65db9
313415tobramycin 0.3 % Ophthalmic SolutionPSNad61ce34-8305-4fd3-bf88-a1e2438128cc9
313415tobramycin 3 MG/ML Ophthalmic SolutionSCDad61ce34-8305-4fd3-bf88-a1e2438128cc9
313415tobramycin 3 MG/ML Ophthalmic SolutionSCD7333280d-5d2a-4609-ab93-3ab7031b65db9
313415tobramycin 0.3 % Ophthalmic SolutionSY7333280d-5d2a-4609-ab93-3ab7031b65db9
313415tobramycin 0.3 % Ophthalmic SolutionSYad61ce34-8305-4fd3-bf88-a1e2438128cc9
313415tobramycin 0.3 % Ophthalmic SolutionPSN94ef5b16-4882-4994-a905-1ee6175161868
313415tobramycin 3 MG/ML Ophthalmic SolutionSCD94ef5b16-4882-4994-a905-1ee6175161868
313415tobramycin 0.3 % Ophthalmic SolutionSY94ef5b16-4882-4994-a905-1ee6175161868
313415tobramycin 0.3 % Ophthalmic SolutionPSN2f95ece0-62f7-47f4-b7ab-90f95fa3dc276
313415tobramycin 3 MG/ML Ophthalmic SolutionSCD2f95ece0-62f7-47f4-b7ab-90f95fa3dc276
313415tobramycin 0.3 % Ophthalmic SolutionSY2f95ece0-62f7-47f4-b7ab-90f95fa3dc276
313415tobramycin 0.3 % Ophthalmic SolutionPSNb119bfa5-33b0-84eb-e053-2995a90a2cad4
313415tobramycin 3 MG/ML Ophthalmic SolutionSCDb119bfa5-33b0-84eb-e053-2995a90a2cad4
313415tobramycin 0.3 % Ophthalmic SolutionSYb119bfa5-33b0-84eb-e053-2995a90a2cad4
313415tobramycin 0.3 % Ophthalmic SolutionPSN87349ae8-4709-7f5a-e053-2a91aa0ae3d13
313415tobramycin 0.3 % Ophthalmic SolutionPSN9263df93-c558-5d9f-e053-2995a90a546c3
313415tobramycin 3 MG/ML Ophthalmic SolutionSCD9263df93-c558-5d9f-e053-2995a90a546c3
313415tobramycin 3 MG/ML Ophthalmic SolutionSCD87349ae8-4709-7f5a-e053-2a91aa0ae3d13
313415tobramycin 0.3 % Ophthalmic SolutionSY9263df93-c558-5d9f-e053-2995a90a546c3
313415tobramycin 0.3 % Ophthalmic SolutionSY87349ae8-4709-7f5a-e053-2a91aa0ae3d13
313415tobramycin 0.3 % Ophthalmic SolutionPSN5564e780-2320-4ce7-b211-806ca99110c31
313415tobramycin 0.3 % Ophthalmic SolutionPSNb37ce61e-5c74-0ac2-e053-2a95a90a318e1
313415tobramycin 0.3 % Ophthalmic SolutionPSN1f3efd7f-1b90-27af-e063-6294a90ae1821
313415tobramycin 0.3 % Ophthalmic SolutionPSNe2aa8499-2eab-4ea2-b122-6c7b1ad0c35c1
313415tobramycin 3 MG/ML Ophthalmic SolutionSCDe2aa8499-2eab-4ea2-b122-6c7b1ad0c35c1
313415tobramycin 3 MG/ML Ophthalmic SolutionSCDb37ce61e-5c74-0ac2-e053-2a95a90a318e1
313415tobramycin 3 MG/ML Ophthalmic SolutionSCD5564e780-2320-4ce7-b211-806ca99110c31
313415tobramycin 3 MG/ML Ophthalmic SolutionSCD1f3efd7f-1b90-27af-e063-6294a90ae1821
313415tobramycin 0.3 % Ophthalmic SolutionSY5564e780-2320-4ce7-b211-806ca99110c31
313415tobramycin 0.3 % Ophthalmic SolutionSYb37ce61e-5c74-0ac2-e053-2a95a90a318e1
313415tobramycin 0.3 % Ophthalmic SolutionSYe2aa8499-2eab-4ea2-b122-6c7b1ad0c35c1
313415tobramycin 0.3 % Ophthalmic SolutionSY1f3efd7f-1b90-27af-e063-6294a90ae1821

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70069-131-01700690131011 BOTTLE in 1 CARTON (70069-131-01) / 5 mL in 1 BOTTLE1 bottle2020-08-110000-00-00NoNoCurrent