Tobramycin

Product NDC
45865-119
Requested package NDC
45865-119-01
11-digit product format
458650119
Labeler code
45865
Product ID
45865-119_b37ce61e-5c75-0ac2-e053-2a95a90a318e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tobramycin
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Medsource Pharmaceuticals
Application
ANDA207444
Marketing category
ANDA
Marketing start
2017-06-28
Marketing end
0000-00-00
Substance
TOBRAMYCIN
Active strength
3 mg/mL
Pharmacologic classes
Aminoglycoside Antibacterial [EPC],Aminoglycosides [CS]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage45865-11945865-119-01IInactivated by FDA2026-08-07

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 9 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A207444-001TOBRAMYCINTOBRAMYCIN0.3%SOLUTION/DROPS / OPHTHALMICATRS2017-06-28

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A207444-001AT

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A207444-001TOBRAMYCIN0.3%SOLUTION/DROPS / OPHTHALMICATRS2017-06-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207444-001TOBRAMYCIN0.3%SOLUTION/DROPS / OPHTHALMICATRS2017-06-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A207444-001TOBRAMYCIN0.3%SOLUTION/DROPS / OPHTHALMICATRS2017-06-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207444-001TOBRAMYCIN0.3%SOLUTION/DROPS / OPHTHALMICATRS2017-06-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207444-001TOBRAMYCIN0.3%SOLUTION/DROPS / OPHTHALMICATRS2017-06-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207444-001TOBRAMYCIN0.3%SOLUTION/DROPS / OPHTHALMICATRS2017-06-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207444-001TOBRAMYCIN0.3%SOLUTION/DROPS / OPHTHALMICATRS2017-06-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207444-001TOBRAMYCIN0.3%SOLUTION/DROPS / OPHTHALMICATRS2017-06-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207444-001TOBRAMYCIN0.3%SOLUTION/DROPS / OPHTHALMICATRS2017-06-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207444-001TOBRAMYCIN0.3%SOLUTION/DROPS / OPHTHALMICATRS2017-06-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207444-001TOBRAMYCIN0.3%SOLUTION/DROPS / OPHTHALMICATRS2017-06-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207444-001TOBRAMYCIN0.3%SOLUTION/DROPS / OPHTHALMICATRS2017-06-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207444-001TOBRAMYCIN0.3%SOLUTION/DROPS / OPHTHALMICATRS2017-06-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207444-001TOBRAMYCIN0.3%SOLUTION/DROPS / OPHTHALMICATRS2017-06-288072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207444-001TOBRAMYCIN0.3%SOLUTION/DROPS / OPHTHALMICAT2017-06-285c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A207444-001TOBRAMYCIN0.3%SOLUTION/DROPS / OPHTHALMICAT2017-06-285d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A207444-001TOBRAMYCIN0.3%SOLUTION/DROPS / OPHTHALMICAT2017-06-284b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A207444-001TOBRAMYCIN0.3%SOLUTION/DROPS / OPHTHALMICAT2017-06-2874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A207444-001TOBRAMYCIN0.3%SOLUTION/DROPS / OPHTHALMICAT2017-06-28bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A207444-001TOBRAMYCIN0.3%SOLUTION/DROPS / OPHTHALMICAT2017-06-28782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A207444-001TOBRAMYCIN0.3%SOLUTION/DROPS / OPHTHALMICAT2017-06-2887673890dc5c…
2021-03-12 10:30 UTC2021-03A207444-001TOBRAMYCIN0.3%SOLUTION/DROPS / OPHTHALMICAT2017-06-285aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A207444-001TOBRAMYCIN0.3%SOLUTION/DROPS / OPHTHALMICAT2017-06-288869cabd3fbd…
2020-11-12 02:37 UTC2020-11A207444-001TOBRAMYCIN0.3%SOLUTION/DROPS / OPHTHALMICAT2017-06-28c0c555d07b60…
2019-12-14 00:12 UTC2019-12A207444-001TOBRAMYCIN0.3%SOLUTION/DROPS / OPHTHALMICAT2017-06-283f01610625f2…
2019-09-15 20:21 UTC2019-09A207444-001TOBRAMYCIN0.3%SOLUTION/DROPS / OPHTHALMICAT2017-06-28b00525d2431f…
2019-07-19 19:46 UTC2019-07A207444-001TOBRAMYCIN0.3%SOLUTION/DROPS / OPHTHALMICAT2017-06-28ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A207444-001TOBRAMYCIN0.3%SOLUTION/DROPS / OPHTHALMICAT2017-06-286a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A207444-001TOBRAMYCIN0.3%SOLUTION/DROPS / OPHTHALMICAT2017-06-281c564ffb4f44…
2023-12-20 04:57 UTC2023-12A207444-001TOBRAMYCIN0.3%SOLUTION/DROPS / OPHTHALMICAT2017-06-28ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A207444-001TOBRAMYCIN0.3%SOLUTION/DROPS / OPHTHALMICAT2017-06-28a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A207444-001TOBRAMYCIN0.3%SOLUTION/DROPS / OPHTHALMICAT2017-06-289b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A207444-001TOBRAMYCIN0.3%SOLUTION/DROPS / OPHTHALMICAT2017-06-28a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A207444-001TOBRAMYCIN0.3%SOLUTION/DROPS / OPHTHALMICAT2017-06-283f0d92c62455…
2023-05-13 08:27 UTC2023-05A207444-001TOBRAMYCIN0.3%SOLUTION/DROPS / OPHTHALMICAT2017-06-28053a50430f4f…
2023-01-26 05:58 UTC2023-01A207444-001TOBRAMYCIN0.3%SOLUTION/DROPS / OPHTHALMICAT2017-06-283bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A207444-001TOBRAMYCIN0.3%SOLUTION/DROPS / OPHTHALMICAT2017-06-283a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A207444-001TOBRAMYCIN0.3%SOLUTION/DROPS / OPHTHALMICAT2017-06-28f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A207444-001TOBRAMYCIN0.3%SOLUTION/DROPS / OPHTHALMICAT2017-06-28e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A207444-001TOBRAMYCIN0.3%SOLUTION/DROPS / OPHTHALMICAT2017-06-28cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A207444-001AT1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207444-001AT131067a03dcf5…
2025-08-23 18:47 UTC2025-08A207444-001AT16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207444-001AT1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207444-001AT1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207444-001AT103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207444-001AT12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207444-001AT15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207444-001AT1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207444-001AT1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207444-001AT179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207444-001AT1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207444-001AT11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207444-001AT18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207444-001AT15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A207444-001AT15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A207444-001AT14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A207444-001AT174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A207444-001AT1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A207444-001AT1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A207444-001AT187673890dc5c…
2021-03-12 10:30 UTC2021-03A207444-001AT15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A207444-001AT18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A207444-001AT1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A207444-001AT13f01610625f2…
2019-09-15 20:21 UTC2019-09A207444-001AT1b00525d2431f…
2019-07-19 19:46 UTC2019-07A207444-001AT1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A207444-001AT16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A207444-001AT11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A207444-001AT1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A207444-001AT1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A207444-001AT19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A207444-001AT1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A207444-001AT13f0d92c62455…
2023-05-13 08:27 UTC2023-05A207444-001AT1053a50430f4f…
2023-01-26 05:58 UTC2023-01A207444-001AT13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A207444-001AT13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A207444-001AT1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A207444-001AT1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A207444-001AT1cb3db0bc1861…

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
941f67d9-7f03-56d2-750c-36de24f654dbProduct name320221117
9cfa145f-dbe9-bc02-83c2-692786ef6676Product name920210928
2f9713b8-5e7e-bbcc-b364-1b2c27a63796Product name420210903
32a533bc-01c7-2b9f-bbf7-ecfb0d964277Product name420210625
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
9f5124fb-08b0-4c3e-8e12-a1a6ff310cbaProduct name120150309
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
45865-119-012025-01-30C16284748780-12cef2736-5fd6-d83d-e063-dadaa90ab31fRx Only For Topical Ophthalmic Use Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45865-119-01Tobramycin5 mL in 1 BOTTLESOLUTION/ DROPS51

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45865-119TOBRAMYCIN SOLUTION/ DROPS [MEDSOURCE PHARMACEUTICALS]1Legacy NDC, 1 package rows20201107_b37ce61e-5c74-0ac2-e053-2a95a90a318e.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 10 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TobramycinTOBRAMYCINSt. Mary's Medical Park Pharmacy9263df93-c558-5d9f-e053-2995a90a546c2026-06-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207444
application number: ANDA207444
TobramycinTOBRAMYCINSportpharm LLCe2aa8499-2eab-4ea2-b122-6c7b1ad0c35c2026-03-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207444
application number: ANDA207444
TobramycinTOBRAMYCINNuCare Pharmaceuticals,Inc.b119bfa5-33b0-84eb-e053-2995a90a2cad2026-02-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207444
application number: ANDA207444
TobramycinTOBRAMYCINREMEDYREPACK INC.3596dacc-6abc-45eb-8085-fa7aaa580a1c2026-01-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207444
application number: ANDA207444
TobramycinTOBRAMYCINPreferred Pharmaceuticals Inc.ad61ce34-8305-4fd3-bf88-a1e2438128cc2025-09-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207444
application number: ANDA207444
TobramycinTOBRAMYCINSomerset Therapeutics, LLC7333280d-5d2a-4609-ab93-3ab7031b65db2025-07-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207444
application number: ANDA207444
TOBRAMYCINTOBRAMYCINDirectRX87349ae8-4709-7f5a-e053-2a91aa0ae3d12024-01-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207444
application number: ANDA207444
TobramycinTOBRAMYCINA-S Medication Solutions94ef5b16-4882-4994-a905-1ee6175161862024-01-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207444
application number: ANDA207444
TobramycinTOBRAMYCINProficient Rx LP2f95ece0-62f7-47f4-b7ab-90f95fa3dc272022-04-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207444
application number: ANDA207444
TobramycinTOBRAMYCINAsclemed USA, Inc.5564e780-2320-4ce7-b211-806ca99110c32020-10-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207444
application number: ANDA207444

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313415tobramycin 0.3 % Ophthalmic SolutionPSNb37ce61e-5c74-0ac2-e053-2a95a90a318e1
313415tobramycin 3 MG/ML Ophthalmic SolutionSCDb37ce61e-5c74-0ac2-e053-2a95a90a318e1
313415tobramycin 0.3 % Ophthalmic SolutionSYb37ce61e-5c74-0ac2-e053-2a95a90a318e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45865-119-01458650119015 mL in 1 BOTTLE (45865-119-01) 5 ml2017-06-280000-00-00NoNoCurrent