Tobramycin

Product NDC
36000-242
11-digit product format
360000242
Labeler code
36000
Product ID
36000-242_19ade85b-3da4-44af-8ad0-d68d15a48193
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tobramycin
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Baxter Healthcare Corporation
Application
ANDA206965
Marketing category
ANDA
Marketing start
2016-07-15
Substance
TOBRAMYCIN SULFATE
Active strength
40 mg/mL
Pharmacologic classes
Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage36000-24236000-242-05DDiscontinued by firm2026-08-10
excluded packagepackage36000-24236000-242-10DDiscontinued by firm2026-08-10

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 · 24 matching rows.

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

Captured / source date, Package NDC, Snapshot table
Captured / source datePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-0536000-242-05d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0536000-242-10d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-2636000-242-05f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2636000-242-10f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-3136000-242-052ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3136000-242-102ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-2836000-242-05a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2836000-242-10a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-2136000-242-05cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2136000-242-10cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-1036000-242-05cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1036000-242-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-3136000-242-05302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-3136000-242-10302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-2036000-242-05ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-2036000-242-10ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-1036000-242-050efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-1036000-242-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-0836000-242-05ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-0836000-242-10ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-0336000-242-05367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-0336000-242-10367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-0936000-242-05557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-0936000-242-10557ba5c1ecfa…9c80585c8c6e…

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
A206965-001TOBRAMYCIN SULFATETOBRAMYCIN SULFATEEQ 40MG BASE/MLINJECTABLE / INJECTIONAP2016-07-01

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A206965-001AP

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 UTC2026-02A206965-001TOBRAMYCIN SULFATEEQ 40MG BASE/MLINJECTABLE / INJECTIONAP2016-07-01011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206965-001TOBRAMYCIN SULFATEEQ 40MG BASE/MLINJECTABLE / INJECTIONAP2016-07-0131067a03dcf5…
2025-08-23 18:47 UTC2025-08A206965-001TOBRAMYCIN SULFATEEQ 40MG BASE/MLINJECTABLE / INJECTIONAP2016-07-016a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206965-001TOBRAMYCIN SULFATEEQ 40MG BASE/MLINJECTABLE / INJECTIONAP2016-07-01fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206965-001TOBRAMYCIN SULFATEEQ 40MG BASE/MLINJECTABLE / INJECTIONAP2016-07-01b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206965-001TOBRAMYCIN SULFATEEQ 40MG BASE/MLINJECTABLE / INJECTIONAP2016-07-0103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206965-001TOBRAMYCIN SULFATEEQ 40MG BASE/MLINJECTABLE / INJECTIONAP2016-07-012680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206965-001TOBRAMYCIN SULFATEEQ 40MG BASE/MLINJECTABLE / INJECTIONAP2016-07-015bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206965-001TOBRAMYCIN SULFATEEQ 40MG BASE/MLINJECTABLE / INJECTIONAP2016-07-01d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A206965-001TOBRAMYCIN SULFATEEQ 40MG BASE/MLINJECTABLE / INJECTIONAP2016-07-01d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206965-001TOBRAMYCIN SULFATEEQ 40MG BASE/MLINJECTABLE / INJECTIONAP2016-07-0179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206965-001TOBRAMYCIN SULFATEEQ 40MG BASE/MLINJECTABLE / INJECTIONAP2016-07-01301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206965-001TOBRAMYCIN SULFATEEQ 40MG BASE/MLINJECTABLE / INJECTIONAP2016-07-011e350fbaab3a…
2024-05-31 18:47 UTC2024-05A206965-001TOBRAMYCIN SULFATEEQ 40MG BASE/MLINJECTABLE / INJECTIONAP2016-07-018072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206965-001TOBRAMYCIN SULFATEEQ 40MG BASE/MLINJECTABLE / INJECTIONAP2016-07-015c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A206965-001TOBRAMYCIN SULFATEEQ 40MG BASE/MLINJECTABLE / INJECTIONAP2016-07-015d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A206965-001TOBRAMYCIN SULFATEEQ 40MG BASE/MLINJECTABLE / INJECTIONAP2016-07-014b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A206965-001TOBRAMYCIN SULFATEEQ 40MG BASE/MLINJECTABLE / INJECTIONAP2016-07-0174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A206965-001TOBRAMYCIN SULFATEEQ 40MG BASE/MLINJECTABLE / INJECTIONAP2016-07-01bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A206965-001TOBRAMYCIN SULFATEEQ 40MG BASE/MLINJECTABLE / INJECTIONAP2016-07-01782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A206965-001TOBRAMYCIN SULFATEEQ 40MG BASE/MLINJECTABLE / INJECTIONAP2016-07-0187673890dc5c…
2021-03-12 10:30 UTC2021-03A206965-001TOBRAMYCIN SULFATEEQ 40MG BASE/MLINJECTABLE / INJECTIONAP2016-07-015aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A206965-001TOBRAMYCIN SULFATEEQ 40MG BASE/MLINJECTABLE / INJECTIONAP2016-07-018869cabd3fbd…
2020-11-12 02:37 UTC2020-11A206965-001TOBRAMYCIN SULFATEEQ 40MG BASE/MLINJECTABLE / INJECTIONAP2016-07-01c0c555d07b60…
2019-12-14 00:12 UTC2019-12A206965-001TOBRAMYCIN SULFATEEQ 40MG BASE/MLINJECTABLE / INJECTIONAP2016-07-013f01610625f2…
2019-09-15 20:21 UTC2019-09A206965-001TOBRAMYCIN SULFATEEQ 40MG BASE/MLINJECTABLE / INJECTIONAP2016-07-01b00525d2431f…
2019-07-19 19:46 UTC2019-07A206965-001TOBRAMYCIN SULFATEEQ 40MG BASE/MLINJECTABLE / INJECTIONAP2016-07-01ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A206965-001TOBRAMYCIN SULFATEEQ 40MG BASE/MLINJECTABLE / INJECTIONAP2016-07-016a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A206965-001TOBRAMYCIN SULFATEEQ 40MG BASE/MLINJECTABLE / INJECTIONAP2016-07-011c564ffb4f44…
2023-12-20 04:57 UTC2023-12A206965-001TOBRAMYCIN SULFATEEQ 40MG BASE/MLINJECTABLE / INJECTIONAP2016-07-01ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A206965-001TOBRAMYCIN SULFATEEQ 40MG BASE/MLINJECTABLE / INJECTIONAP2016-07-01a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A206965-001TOBRAMYCIN SULFATEEQ 40MG BASE/MLINJECTABLE / INJECTIONAP2016-07-019b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A206965-001TOBRAMYCIN SULFATEEQ 40MG BASE/MLINJECTABLE / INJECTIONAP2016-07-01a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A206965-001TOBRAMYCIN SULFATEEQ 40MG BASE/MLINJECTABLE / INJECTIONAP2016-07-013f0d92c62455…
2023-05-13 08:27 UTC2023-05A206965-001TOBRAMYCIN SULFATEEQ 40MG BASE/MLINJECTABLE / INJECTIONAP2016-07-01053a50430f4f…
2023-01-26 05:58 UTC2023-01A206965-001TOBRAMYCIN SULFATEEQ 40MG BASE/MLINJECTABLE / INJECTIONAP2016-07-013bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A206965-001TOBRAMYCIN SULFATEEQ 40MG BASE/MLINJECTABLE / INJECTIONAP2016-07-013a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A206965-001TOBRAMYCIN SULFATEEQ 40MG BASE/MLINJECTABLE / INJECTIONAP2016-07-01f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A206965-001TOBRAMYCIN SULFATEEQ 40MG BASE/MLINJECTABLE / INJECTIONAP2016-07-01e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A206965-001TOBRAMYCIN SULFATEEQ 40MG BASE/MLINJECTABLE / INJECTIONAP2016-07-01cb3db0bc1861…

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 UTC2026-02A206965-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206965-001AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A206965-001AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206965-001AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206965-001AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206965-001AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206965-001AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206965-001AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206965-001AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A206965-001AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206965-001AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206965-001AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206965-001AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A206965-001AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206965-001AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A206965-001AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A206965-001AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A206965-001AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A206965-001AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A206965-001AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A206965-001AP187673890dc5c…
2021-03-12 10:30 UTC2021-03A206965-001AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A206965-001AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A206965-001AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A206965-001AP13f01610625f2…
2019-09-15 20:21 UTC2019-09A206965-001AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07A206965-001AP1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A206965-001AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A206965-001AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A206965-001AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A206965-001AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A206965-001AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A206965-001AP1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A206965-001AP13f0d92c62455…
2023-05-13 08:27 UTC2023-05A206965-001AP1053a50430f4f…
2023-01-26 05:58 UTC2023-01A206965-001AP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A206965-001AP13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A206965-001AP1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A206965-001AP1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A206965-001AP1cb3db0bc1861…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TOBRAMYCIN SULFATE40 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
HJT0RXD7JKInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
597823Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
a9897444-71f6-42af-9b71-4aa77829ade0Available on FDA.report

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
36000-242-01Tobramycin1 in 1 CARTONINJECTION116
36000-242-01Tobramycin30 mL in 1 VIAL, MULTI-DOSEINJECTION3016
36000-242-05Tobramycin30 mL in 1 VIALINJECTION3016
36000-242-05Tobramycin5 in 1 CARTONINJECTION516
36000-242-10Tobramycin10 in 1 CARTONINJECTION1016
36000-242-10Tobramycin30 mL in 1 VIALINJECTION3016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
36000-242-01ML - Milliliter36000-242d55d9e95-edb7-4a5e-8fb0-ef21085bb0c912016-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36000-242TOBRAMYCIN INJECTION [BAXTER HEALTHCARE CORPORATION]15Current NDC, Legacy NDC, 6 package rows20240922_a9897444-71f6-42af-9b71-4aa77829ade0.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TobramycinTOBRAMYCINBaxter Healthcare Corporationa9897444-71f6-42af-9b71-4aa77829ade02023-03-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206965
application number: ANDA206965
ndc (product): 36000-242

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
597823tobramycin 40 MG/ML Injectable SolutionPSNa9897444-71f6-42af-9b71-4aa77829ade016
597823tobramycin 40 MG/ML Injectable SolutionSCDa9897444-71f6-42af-9b71-4aa77829ade016
597823tobramycin (as tobramycin sulfate) 40 MG/ML Injectable SolutionSYa9897444-71f6-42af-9b71-4aa77829ade016

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
36000-242-01360000242011 VIAL, MULTI-DOSE in 1 CARTON (36000-242-01) / 30 mL in 1 VIAL, MULTI-DOSE2016-07-150000-00-00NoNoCurrent
36000-242-053600002420530 mL in 1 VIAL30 mlHistorical
36000-242-103600002421010 in 1 CARTONHistorical