Tobramycin and Dexamethasone

Product NDC
68071-4203
11-digit product format
680714203
Labeler code
68071
Product ID
68071-4203_1a3b96b0-10ad-9bb1-e063-6294a90ab279
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tobramycin and Dexamethasone
Dosage form
SUSPENSION/ DROPS
Route
OPHTHALMIC
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA064134
Marketing category
ANDA
Marketing start
1999-10-27
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

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 · 6 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage68071-4203-58af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage68071-4203-5834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage68071-4203-51332a3947898…d4bfe170f9cd…

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
A064134-001TOBRAMYCIN AND DEXAMETHASONEDEXAMETHASONE; TOBRAMYCIN0.1%;0.3%SUSPENSION/DROPS / OPHTHALMICAB1999-10-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A064134-001AB

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 UTC2026-02A064134-001TOBRAMYCIN AND DEXAMETHASONE0.1%;0.3%SUSPENSION/DROPS / OPHTHALMICAB1999-10-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A064134-001TOBRAMYCIN AND DEXAMETHASONE0.1%;0.3%SUSPENSION/DROPS / OPHTHALMICAB1999-10-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08A064134-001TOBRAMYCIN AND DEXAMETHASONE0.1%;0.3%SUSPENSION/DROPS / OPHTHALMICAB1999-10-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A064134-001TOBRAMYCIN AND DEXAMETHASONE0.1%;0.3%SUSPENSION/DROPS / OPHTHALMICAB1999-10-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A064134-001TOBRAMYCIN AND DEXAMETHASONE0.1%;0.3%SUSPENSION/DROPS / OPHTHALMICAB1999-10-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A064134-001TOBRAMYCIN AND DEXAMETHASONE0.1%;0.3%SUSPENSION/DROPS / OPHTHALMICAB1999-10-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A064134-001TOBRAMYCIN AND DEXAMETHASONE0.1%;0.3%SUSPENSION/DROPS / OPHTHALMICAB1999-10-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A064134-001TOBRAMYCIN AND DEXAMETHASONE0.1%;0.3%SUSPENSION/DROPS / OPHTHALMICAB1999-10-275bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A064134-001TOBRAMYCIN AND DEXAMETHASONE0.1%;0.3%SUSPENSION/DROPS / OPHTHALMICAB1999-10-27d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A064134-001TOBRAMYCIN AND DEXAMETHASONE0.1%;0.3%SUSPENSION/DROPS / OPHTHALMICAB1999-10-27d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A064134-001TOBRAMYCIN AND DEXAMETHASONE0.1%;0.3%SUSPENSION/DROPS / OPHTHALMICAB1999-10-2779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A064134-001TOBRAMYCIN AND DEXAMETHASONE0.1%;0.3%SUSPENSION/DROPS / OPHTHALMICAB1999-10-27301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A064134-001TOBRAMYCIN AND DEXAMETHASONE0.1%;0.3%SUSPENSION/DROPS / OPHTHALMICAB1999-10-271e350fbaab3a…
2024-05-31 18:47 UTC2024-05A064134-001TOBRAMYCIN AND DEXAMETHASONE0.1%;0.3%SUSPENSION/DROPS / OPHTHALMICAB1999-10-278072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A064134-001TOBRAMYCIN AND DEXAMETHASONE0.1%;0.3%SUSPENSION/DROPS / OPHTHALMICAB1999-10-275c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A064134-001TOBRAMYCIN AND DEXAMETHASONE0.1%;0.3%SUSPENSION/DROPS / OPHTHALMICAB1999-10-275d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A064134-001TOBRAMYCIN AND DEXAMETHASONE0.1%;0.3%SUSPENSION/DROPS / OPHTHALMICAB1999-10-274b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A064134-001TOBRAMYCIN AND DEXAMETHASONE0.1%;0.3%SUSPENSION/DROPS / OPHTHALMICAB1999-10-2774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A064134-001TOBRAMYCIN AND DEXAMETHASONE0.1%;0.3%SUSPENSION/DROPS / OPHTHALMICAB1999-10-27bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A064134-001TOBRAMYCIN AND DEXAMETHASONE0.1%;0.3%SUSPENSION/DROPS / OPHTHALMICAB1999-10-27782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A064134-001TOBRAMYCIN AND DEXAMETHASONE0.1%;0.3%SUSPENSION/DROPS / OPHTHALMICAB1999-10-2787673890dc5c…
2021-03-12 10:30 UTC2021-03A064134-001TOBRAMYCIN AND DEXAMETHASONE0.1%;0.3%SUSPENSION/DROPS / OPHTHALMICAB1999-10-275aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A064134-001TOBRAMYCIN AND DEXAMETHASONE0.1%;0.3%SUSPENSION/DROPS / OPHTHALMICAB1999-10-278869cabd3fbd…
2020-11-12 02:37 UTC2020-11A064134-001TOBRAMYCIN AND DEXAMETHASONE0.1%;0.3%SUSPENSION/DROPS / OPHTHALMICAB1999-10-27c0c555d07b60…
2019-12-14 00:12 UTC2019-12A064134-001TOBRAMYCIN AND DEXAMETHASONE0.1%;0.3%SUSPENSION/DROPS / OPHTHALMICAB1999-10-273f01610625f2…
2019-09-15 20:21 UTC2019-09A064134-001TOBRAMYCIN AND DEXAMETHASONE0.1%;0.3%SUSPENSION/DROPS / OPHTHALMICAB1999-10-27b00525d2431f…
2019-07-19 19:46 UTC2019-07A064134-001TOBRAMYCIN AND DEXAMETHASONE0.1%;0.3%SUSPENSION/DROPS / OPHTHALMICAB1999-10-27ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A064134-001TOBRAMYCIN AND DEXAMETHASONE0.1%;0.3%SUSPENSION/DROPS / OPHTHALMICAB1999-10-276a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A064134-001TOBRAMYCIN AND DEXAMETHASONE0.1%;0.3%SUSPENSION/DROPS / OPHTHALMICAB1999-10-271c564ffb4f44…
2023-12-20 04:57 UTC2023-12A064134-001TOBRAMYCIN AND DEXAMETHASONE0.1%;0.3%SUSPENSION/DROPS / OPHTHALMICAB1999-10-27ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A064134-001TOBRAMYCIN AND DEXAMETHASONE0.1%;0.3%SUSPENSION/DROPS / OPHTHALMICAB1999-10-27a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A064134-001TOBRAMYCIN AND DEXAMETHASONE0.1%;0.3%SUSPENSION/DROPS / OPHTHALMICAB1999-10-279b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A064134-001TOBRAMYCIN AND DEXAMETHASONE0.1%;0.3%SUSPENSION/DROPS / OPHTHALMICAB1999-10-27a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A064134-001TOBRAMYCIN AND DEXAMETHASONE0.1%;0.3%SUSPENSION/DROPS / OPHTHALMICAB1999-10-273f0d92c62455…
2023-05-13 08:27 UTC2023-05A064134-001TOBRAMYCIN AND DEXAMETHASONE0.1%;0.3%SUSPENSION/DROPS / OPHTHALMICAB1999-10-27053a50430f4f…
2023-01-26 05:58 UTC2023-01A064134-001TOBRAMYCIN AND DEXAMETHASONE0.1%;0.3%SUSPENSION/DROPS / OPHTHALMICAB1999-10-273bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A064134-001TOBRAMYCIN AND DEXAMETHASONE0.1%;0.3%SUSPENSION/DROPS / OPHTHALMICAB1999-10-273a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A064134-001TOBRAMYCIN AND DEXAMETHASONE0.1%;0.3%SUSPENSION/DROPS / OPHTHALMICAB1999-10-27f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A064134-001TOBRAMYCIN AND DEXAMETHASONE0.1%;0.3%SUSPENSION/DROPS / OPHTHALMICAB1999-10-27e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A064134-001TOBRAMYCIN AND DEXAMETHASONE0.1%;0.3%SUSPENSION/DROPS / OPHTHALMICAB1999-10-27cb3db0bc1861…

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 UTC2026-02A064134-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A064134-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A064134-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A064134-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A064134-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A064134-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A064134-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A064134-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A064134-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A064134-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A064134-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A064134-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A064134-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A064134-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A064134-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A064134-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A064134-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A064134-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A064134-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A064134-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A064134-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A064134-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A064134-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A064134-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A064134-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A064134-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A064134-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A064134-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A064134-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A064134-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A064134-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A064134-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A064134-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A064134-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A064134-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A064134-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A064134-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A064134-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A064134-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A064134-001AB1cb3db0bc1861…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TOBRAMYCIN1 mg/mL
DEXAMETHASONE3 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
VZ8RRZ51VKInternal UNII lookup
7S5I7G3JQLInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
309683Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
61693e79-81d1-3162-e053-2a91aa0ae925Available on FDA.report

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
941f67d9-7f03-56d2-750c-36de24f654dbProduct name320221117
d7d46a10-8766-d3c8-ebf2-2ccd9efdcae8Product name220220506
7b2c58e8-5850-4e3e-82e9-b1593b1de761Product name520220210
9cfa145f-dbe9-bc02-83c2-692786ef6676Product name920210928
2f9713b8-5e7e-bbcc-b364-1b2c27a63796Product name420210903
32a533bc-01c7-2b9f-bbf7-ecfb0d964277Product name420210625
81e34474-b0a5-434f-8104-25d689efc99eProduct name120200303
05ab9c01-cd9a-4f59-b2e8-ddcb887cac39Product name120190408
0c7dba41-c919-5809-508d-4affe6cfcff2Product name220170817
9f5124fb-08b0-4c3e-8e12-a1a6ff310cbaProduct name120150309
399647c0-db89-02d1-991c-0c17b584482cProduct name120140508
3e9a6377-704f-dff7-b19f-56c98d40c444Product name120140508
4d2e6ff9-14f5-b84f-c39b-373b005712c1Product name120140508
725d71bf-f956-5cad-e556-fa39cb060dc8Product name120140508
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-4203-5Tobramycin and Dexamethasone5 mL in 1 BOXSUSPENSION/ DROPS54

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-4203TOBRAMYCIN AND DEXAMETHASONE SUSPENSION/ DROPS [NUCARE PHARMACEUTICALS,INC.]4Current NDC, Legacy NDC, 1 package rows20240608_61693e79-81d1-3162-e053-2a91aa0ae925.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 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tobramycin and DexamethasoneTOBRAMYCIN AND DEXAMETHASONESportpharm LLCfa3d2fda-6857-4ef1-8dae-a2877f7569af2026-07-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 064134
application number: ANDA064134
Tobramycin and DexamethasoneTOBRAMYCIN AND DEXAMETHASONENuCare Pharmaceuticals,Inc.c33e84ba-4c0c-f738-e053-2995a90aa20a2026-03-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 064134
application number: ANDA064134
Tobramycin and DexamethasoneTOBRAMYCIN AND DEXAMETHASONESportpharm LLC7ed85675-bc46-4dd6-bb8f-7e98c3eb84e22026-03-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 064134
application number: ANDA064134
Tobramycin and DexamethasoneTOBRAMYCIN AND DEXAMETHASONEA-S Medication Solutionscdd9086d-821f-4ac8-bc49-f1869dffb1502026-01-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 064134
application number: ANDA064134
Tobramycin and DexamethasoneTOBRAMYCIN AND DEXAMETHASONENuCare Pharmaceuticals,Inc.b7b39ad5-e158-b8fe-e053-2995a90a52792025-02-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 064134
application number: ANDA064134
Tobramycin and DexamethasoneTOBRAMYCIN AND DEXAMETHASONENuCare Pharmaceuticals,Inc.61693e79-81d1-3162-e053-2a91aa0ae9252024-06-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 064134
application number: ANDA064134
ndc (product): 68071-4203
Tobramycin and DexamethasoneTOBRAMYCIN AND DEXAMETHASONEBausch & Lomb Incorporated33de419e-a89b-47e5-952b-87e837f5d5312023-08-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 064134
application number: ANDA064134

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309683tobramycin 0.3 % / dexAMETHasone 0.1 % Ophthalmic SuspensionPSN61693e79-81d1-3162-e053-2a91aa0ae9254
309683dexamethasone 1 MG/ML / tobramycin 3 MG/ML Ophthalmic SuspensionSCD61693e79-81d1-3162-e053-2a91aa0ae9254
309683dexamethasone 0.1 % / tobramycin 0.3 % Ophthalmic SuspensionSY61693e79-81d1-3162-e053-2a91aa0ae9254

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-4203-5680714203055 mL in 1 BOX (68071-4203-5) 5 ml2017-12-280000-00-00NoNoCurrent