Home NDC 82667-011 Tobradex ST
Product NDC 82667-011
11-digit product format 826670011
Labeler code 82667
Product ID 82667-011_31ba978f-7bc8-031f-e063-6394a90ae09c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name tobramycin / dexamethasone
Dosage form SUSPENSION/ DROPS
Route OPHTHALMIC
Labeler Harrow Eye, LLC
Application NDA050818
Marketing category NDA
Marketing start 2025-03-31
Substance DEXAMETHASONE; TOBRAMYCIN
Active strength .5; 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 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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N050818-001 TOBRADEX ST DEXAMETHASONE; TOBRAMYCIN 0.05%;0.3% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2009-02-13
Orange Book patents# Current patent rows page 1 of 1 · 3 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N050818-001 8101582 2027-12-19 U-1082 Drug product 2012-09-27 N050818-001 8450287 2027-12-19 Drug product 2016-02-16 N050818-001 7795316 2028-08-03 U-1082 Drug product 2010-09-30
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N050818-001 TOBRADEX ST 0.05%;0.3% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2009-02-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N050818-001 TOBRADEX ST 0.05%;0.3% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2009-02-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N050818-001 TOBRADEX ST 0.05%;0.3% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2009-02-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N050818-001 TOBRADEX ST 0.05%;0.3% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2009-02-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N050818-001 TOBRADEX ST 0.05%;0.3% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2009-02-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N050818-001 TOBRADEX ST 0.05%;0.3% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2009-02-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N050818-001 TOBRADEX ST 0.05%;0.3% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2009-02-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N050818-001 TOBRADEX ST 0.05%;0.3% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2009-02-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N050818-001 TOBRADEX ST 0.05%;0.3% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2009-02-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N050818-001 TOBRADEX ST 0.05%;0.3% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2009-02-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N050818-001 TOBRADEX ST 0.05%;0.3% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2009-02-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N050818-001 TOBRADEX ST 0.05%;0.3% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2009-02-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N050818-001 TOBRADEX ST 0.05%;0.3% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2009-02-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N050818-001 TOBRADEX ST 0.05%;0.3% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2009-02-13 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N050818-001 TOBRADEX ST 0.05%;0.3% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2009-02-13 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N050818-001 TOBRADEX ST 0.05%;0.3% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2009-02-13 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N050818-001 TOBRADEX ST 0.05%;0.3% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2009-02-13 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N050818-001 TOBRADEX ST 0.05%;0.3% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2009-02-13 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N050818-001 TOBRADEX ST 0.05%;0.3% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2009-02-13 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N050818-001 TOBRADEX ST 0.05%;0.3% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2009-02-13 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N050818-001 TOBRADEX ST 0.05%;0.3% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2009-02-13 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N050818-001 TOBRADEX ST 0.05%;0.3% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2009-02-13 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N050818-001 TOBRADEX ST 0.05%;0.3% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2009-02-13 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N050818-001 TOBRADEX ST 0.05%;0.3% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2009-02-13 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N050818-001 TOBRADEX ST 0.05%;0.3% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2009-02-13 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N050818-001 TOBRADEX ST 0.05%;0.3% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2009-02-13 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N050818-001 TOBRADEX ST 0.05%;0.3% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2009-02-13 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N050818-001 TOBRADEX ST 0.05%;0.3% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2009-02-13 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N050818-001 TOBRADEX ST 0.05%;0.3% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2009-02-13 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N050818-001 TOBRADEX ST 0.05%;0.3% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2009-02-13 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N050818-001 TOBRADEX ST 0.05%;0.3% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2009-02-13 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N050818-001 TOBRADEX ST 0.05%;0.3% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2009-02-13 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N050818-001 TOBRADEX ST 0.05%;0.3% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2009-02-13 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N050818-001 TOBRADEX ST 0.05%;0.3% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2009-02-13 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N050818-001 TOBRADEX ST 0.05%;0.3% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2009-02-13 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N050818-001 TOBRADEX ST 0.05%;0.3% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2009-02-13 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N050818-001 TOBRADEX ST 0.05%;0.3% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2009-02-13 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N050818-001 TOBRADEX ST 0.05%;0.3% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2009-02-13 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N050818-001 TOBRADEX ST 0.05%;0.3% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2009-02-13 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N050818-001 TOBRADEX ST 0.05%;0.3% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2009-02-13 cb3db0bc1861…
Observed Orange Book patent history# Patent history page 1 of 4 · 123 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N050818-001 8101582 2027-12-19 U-1082 Drug product 2012-09-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N050818-001 8450287 2027-12-19 Drug product 2016-02-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N050818-001 7795316 2028-08-03 U-1082 Drug product 2010-09-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N050818-001 8101582 2027-12-19 U-1082 Drug product 2012-09-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N050818-001 8450287 2027-12-19 Drug product 2016-02-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N050818-001 7795316 2028-08-03 U-1082 Drug product 2010-09-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N050818-001 8101582 2027-12-19 U-1082 Drug product 2012-09-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N050818-001 8450287 2027-12-19 Drug product 2016-02-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N050818-001 7795316 2028-08-03 U-1082 Drug product 2010-09-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N050818-001 8101582 2027-12-19 U-1082 Drug product 2012-09-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N050818-001 8450287 2027-12-19 Drug product 2016-02-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N050818-001 7795316 2028-08-03 U-1082 Drug product 2010-09-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N050818-001 8101582 2027-12-19 U-1082 Drug product 2012-09-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N050818-001 8450287 2027-12-19 Drug product 2016-02-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N050818-001 7795316 2028-08-03 U-1082 Drug product 2010-09-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N050818-001 8101582 2027-12-19 U-1082 Drug product 2012-09-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N050818-001 8450287 2027-12-19 Drug product 2016-02-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N050818-001 7795316 2028-08-03 U-1082 Drug product 2010-09-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N050818-001 8101582 2027-12-19 U-1082 Drug product 2012-09-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N050818-001 8450287 2027-12-19 Drug product 2016-02-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N050818-001 7795316 2028-08-03 U-1082 Drug product 2010-09-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N050818-001 8101582 2027-12-19 U-1082 Drug product 2012-09-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N050818-001 8450287 2027-12-19 Drug product 2016-02-16 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N050818-001 7795316 2028-08-03 U-1082 Drug product 2010-09-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N050818-001 8101582 2027-12-19 U-1082 Drug product 2012-09-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N050818-001 8450287 2027-12-19 Drug product 2016-02-16 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N050818-001 7795316 2028-08-03 U-1082 Drug product 2010-09-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N050818-001 8101582 2027-12-19 U-1082 Drug product 2012-09-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N050818-001 8450287 2027-12-19 Drug product 2016-02-16 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N050818-001 7795316 2028-08-03 U-1082 Drug product 2010-09-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N050818-001 8101582 2027-12-19 U-1082 Drug product 2012-09-27 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N050818-001 8450287 2027-12-19 Drug product 2016-02-16 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N050818-001 7795316 2028-08-03 U-1082 Drug product 2010-09-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N050818-001 8101582 2027-12-19 U-1082 Drug product 2012-09-27 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N050818-001 8450287 2027-12-19 Drug product 2016-02-16 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N050818-001 7795316 2028-08-03 U-1082 Drug product 2010-09-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N050818-001 8101582 2027-12-19 U-1082 Drug product 2012-09-27 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N050818-001 8450287 2027-12-19 Drug product 2016-02-16 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N050818-001 7795316 2028-08-03 U-1082 Drug product 2010-09-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N050818-001 8101582 2027-12-19 U-1082 Drug product 2012-09-27 8072bd15b7f6…
Additional Listing Data#
Finished product Yes
Brand name base Tobradex ST
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TOBRAMYCIN .5 mg/mL DEXAMETHASONE 3 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination VZ8RRZ51VK Internal UNII lookup 7S5I7G3JQL Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 849115 Internal RxNorm lookup 1011080 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 82667-011-00 Tobradex ST 1 mL in 1 BOTTLE, DROPPER SUSPENSION/ DROPS 1 3 82667-011-00 Tobradex ST 1 in 1 CARTON SUSPENSION/ DROPS 1 3 82667-011-05 Tobradex ST 5 mL in 1 BOTTLE, DROPPER SUSPENSION/ DROPS 5 3 82667-011-05 Tobradex ST 1 in 1 CARTON SUSPENSION/ DROPS 1 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 82667-011 TOBRADEX ST (TOBRAMYCIN / DEXAMETHASONE) SUSPENSION/ DROPS [HARROW EYE, LLC] 3 Current NDC, 4 package rows 20250403_3b99dbb3-ac84-4d0d-b30f-a5db44fdc316.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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 82667-011-00 82667001100 1 BOTTLE, DROPPER in 1 CARTON (82667-011-00) / 1 mL in 1 BOTTLE, DROPPER 2025-03-31 No No Current 82667-011-05 82667001105 1 BOTTLE, DROPPER in 1 CARTON (82667-011-05) / 5 mL in 1 BOTTLE, DROPPER 2025-03-31 No No Current