FDA.reportPublic FDA data

Tobramycin

Product NDC
0093-3750
11-digit product format
000933750
Labeler code
0093
Product ID
0093-3750_8aa98982-a156-4bc8-8d31-9a39b88808ed
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tobramycin
Dosage form
SOLUTION
Route
RESPIRATORY (INHALATION)
Labeler
Teva Pharmaceuticals USA, Inc.
Application
ANDA210915
Marketing category
ANDA
Marketing start
2020-09-15
Marketing end
2026-06-30
Substance
TOBRAMYCIN
Active strength
300 mg/4mL
Pharmacologic classes
Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]
NDC exclude flag
No
Current FDA listing
Yes

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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0093-3750DDiscontinued by firm2026-08-10
excluded packagepackage0093-37500093-3750-28DDiscontinued by firm2026-08-10
excluded packagepackage0093-37500093-3750-63DDiscontinued by firm2026-08-10

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
A210915-001TOBRAMYCINTOBRAMYCIN300MG/4MLSOLUTION / INHALATIONAN2019-06-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A210915-001AN

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 UTC2026-02A210915-001TOBRAMYCIN300MG/4MLSOLUTION / INHALATIONAN2019-06-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210915-001TOBRAMYCIN300MG/4MLSOLUTION / INHALATIONAN2019-06-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08A210915-001TOBRAMYCIN300MG/4MLSOLUTION / INHALATIONAN2019-06-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210915-001TOBRAMYCIN300MG/4MLSOLUTION / INHALATIONAN2019-06-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210915-001TOBRAMYCIN300MG/4MLSOLUTION / INHALATIONAN2019-06-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210915-001TOBRAMYCIN300MG/4MLSOLUTION / INHALATIONAN2019-06-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210915-001TOBRAMYCIN300MG/4MLSOLUTION / INHALATIONAN2019-06-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210915-001TOBRAMYCIN300MG/4MLSOLUTION / INHALATIONAN2019-06-265bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210915-001TOBRAMYCIN300MG/4MLSOLUTION / INHALATIONAN2019-06-26d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210915-001TOBRAMYCIN300MG/4MLSOLUTION / INHALATIONAN2019-06-26d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210915-001TOBRAMYCIN300MG/4MLSOLUTION / INHALATIONAN2019-06-2679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210915-001TOBRAMYCIN300MG/4MLSOLUTION / INHALATIONAN2019-06-26301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210915-001TOBRAMYCIN300MG/4MLSOLUTION / INHALATIONAN2019-06-261e350fbaab3a…
2024-05-31 18:47 UTC2024-05A210915-001TOBRAMYCIN300MG/4MLSOLUTION / INHALATIONAN2019-06-268072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210915-001TOBRAMYCIN300MG/4MLSOLUTION / INHALATIONAN2019-06-265c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A210915-001TOBRAMYCIN300MG/4MLSOLUTION / INHALATIONAN2019-06-265d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A210915-001TOBRAMYCIN300MG/4MLSOLUTION / INHALATIONAN2019-06-264b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A210915-001TOBRAMYCIN300MG/4MLSOLUTION / INHALATION2019-06-2674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A210915-001TOBRAMYCIN300MG/4MLSOLUTION / INHALATIONAN2019-06-26bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A210915-001TOBRAMYCIN300MG/4MLSOLUTION / INHALATIONAN2019-06-26782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A210915-001TOBRAMYCIN300MG/4MLSOLUTION / INHALATIONAN2019-06-2687673890dc5c…
2021-03-12 10:30 UTC2021-03A210915-001TOBRAMYCIN300MG/4MLSOLUTION / INHALATIONAN2019-06-265aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A210915-001TOBRAMYCIN300MG/4MLSOLUTION / INHALATIONAN2019-06-268869cabd3fbd…
2020-11-12 02:37 UTC2020-11A210915-001TOBRAMYCIN300MG/4MLSOLUTION / INHALATIONAN2019-06-26c0c555d07b60…
2019-12-14 00:12 UTC2019-12A210915-001TOBRAMYCIN300MG/4MLSOLUTION / INHALATION2019-06-263f01610625f2…
2019-09-15 20:21 UTC2019-09A210915-001TOBRAMYCIN300MG/4MLSOLUTION / INHALATION2019-06-26b00525d2431f…
2019-07-19 19:46 UTC2019-07A210915-001TOBRAMYCIN300MG/4MLSOLUTION / INHALATIONAN2019-06-26ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A210915-001TOBRAMYCIN300MG/4MLSOLUTION / INHALATIONAN2019-06-266a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A210915-001TOBRAMYCIN300MG/4MLSOLUTION / INHALATIONAN2019-06-261c564ffb4f44…
2023-12-20 04:57 UTC2023-12A210915-001TOBRAMYCIN300MG/4MLSOLUTION / INHALATIONAN2019-06-26ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A210915-001TOBRAMYCIN300MG/4MLSOLUTION / INHALATIONAN2019-06-26a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A210915-001TOBRAMYCIN300MG/4MLSOLUTION / INHALATIONAN2019-06-269b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A210915-001TOBRAMYCIN300MG/4MLSOLUTION / INHALATIONAN2019-06-26a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A210915-001TOBRAMYCIN300MG/4MLSOLUTION / INHALATIONAN2019-06-263f0d92c62455…
2023-05-13 08:27 UTC2023-05A210915-001TOBRAMYCIN300MG/4MLSOLUTION / INHALATIONAN2019-06-26053a50430f4f…
2023-01-26 05:58 UTC2023-01A210915-001TOBRAMYCIN300MG/4MLSOLUTION / INHALATIONAN2019-06-263bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A210915-001TOBRAMYCIN300MG/4MLSOLUTION / INHALATIONAN2019-06-263a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A210915-001TOBRAMYCIN300MG/4MLSOLUTION / INHALATIONAN2019-06-26f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A210915-001TOBRAMYCIN300MG/4MLSOLUTION / INHALATIONAN2019-06-26e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A210915-001TOBRAMYCIN300MG/4MLSOLUTION / INHALATIONAN2019-06-26cb3db0bc1861…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A210915-001AN1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210915-001AN131067a03dcf5…
2025-08-23 18:47 UTC2025-08A210915-001AN16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210915-001AN1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210915-001AN1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210915-001AN103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210915-001AN12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210915-001AN15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210915-001AN1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210915-001AN1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210915-001AN179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210915-001AN1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210915-001AN11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A210915-001AN18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210915-001AN15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A210915-001AN15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A210915-001AN14b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A210915-001AN1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A210915-001AN1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A210915-001AN187673890dc5c…
2021-03-12 10:30 UTC2021-03A210915-001AN15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A210915-001AN18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A210915-001AN1c0c555d07b60…
2019-07-19 19:46 UTC2019-07A210915-001AN1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A210915-001AN16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A210915-001AN11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A210915-001AN1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A210915-001AN1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A210915-001AN19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A210915-001AN1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A210915-001AN13f0d92c62455…
2023-05-13 08:27 UTC2023-05A210915-001AN1053a50430f4f…
2023-01-26 05:58 UTC2023-01A210915-001AN13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A210915-001AN13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A210915-001AN1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A210915-001AN1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A210915-001AN1cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A210915-001AN1a50c72e98297…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f297c7c1-845a-4369-8c02-c51b92d6ae8eProduct name320240725
551d952d-4ce2-24f0-9ab0-630ad9aae596Product name220231211
941f67d9-7f03-56d2-750c-36de24f654dbProduct name320221117
9cfa145f-dbe9-bc02-83c2-692786ef6676Product name920210928
2f9713b8-5e7e-bbcc-b364-1b2c27a63796Product name420210903
32a533bc-01c7-2b9f-bbf7-ecfb0d964277Product name420210625
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0093-3750-28Tobramycin7 in 1 CARTONSOLUTION76
0093-3750-28Tobramycin4 in 1 POUCHSOLUTION46
0093-3750-63Tobramycin4 in 1 POUCHSOLUTION46
0093-3750-63Tobramycin14 in 1 CARTONSOLUTION146

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0093-3750TOBRAMYCIN SOLUTION [TEVA PHARMACEUTICALS USA, INC.]5Current NDC, Legacy NDC, 4 package rows20250226_d03079d2-5617-4628-92b9-3caa757b22c0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1314763tobramycin 300 MG in 4 ML Inhalation SolutionPSNd03079d2-5617-4628-92b9-3caa757b22c06
1314763tobramycin 75 MG/ML Inhalation SolutionSCDd03079d2-5617-4628-92b9-3caa757b22c06
1314763tobramycin 300 MG per 4 ML Inhalation SolutionSYd03079d2-5617-4628-92b9-3caa757b22c06

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0093-3750-28000933750287 POUCH in 1 CARTON (0093-3750-28) / 4 AMPULE in 1 POUCH / 4 mL in 1 AMPULE7 pouch2020-09-152026-06-30NoNoCurrent
0093-3750-630009337506314 POUCH in 1 CARTON (0093-3750-63) / 4 AMPULE in 1 POUCH / 4 mL in 1 AMPULE14 pouch2020-09-152026-06-30NoNoCurrent