Home NDC 0065-0652 TOBRADEX ST
Product NDC 0065-0652
11-digit product format 000650652
Labeler code 0065
Product ID 0065-0652_b4d51600-aad6-4b6b-a468-5e001489dd87
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name tobramycin / dexamethasone
Dosage form SUSPENSION/ DROPS
Route OPHTHALMIC
Labeler Alcon Laboratories, Inc.
Application NDA050818
Marketing category NDA
Marketing start 2010-09-07
Marketing end 2021-06-30
Substance TOBRAMYCIN; DEXAMETHASONE
Active strength 3 mg/mL; mg/mL
Pharmacologic classes Aminoglycoside Antibacterial [EPC],Aminoglycosides [CS],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag No
Listing certified through 0000-00-00
Current FDA listing Historical FDA.report record 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 · 60 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 · 42 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 2026-08-18 06:07:40 2026-07 N050818-001 TOBRADEX ST 0.05%;0.3% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2009-02-13 caaa826d4ba7…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…
Observed Orange Book patent history# Patent history page 1 of 4 · 126 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-18 06:07:40 2026-07 N050818-001 8101582 2027-12-19 U-1082 Drug product 2012-09-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N050818-001 8450287 2027-12-19 Drug product 2016-02-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N050818-001 7795316 2028-08-03 U-1082 Drug product 2010-09-30 caaa826d4ba7…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…
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DEXAMETHASONE ACTIVE INGREDIENT 7S5I7G3JQL TOBRADEX ST (TOBRAMYCIN / DEXAMETHASONE) SUSPENSION [ALCON LABORATORIES, INC.] 6 TOBRAMYCIN ACTIVE INGREDIENT VZ8RRZ51VK TOBRADEX ST (TOBRAMYCIN / DEXAMETHASONE) SUSPENSION [ALCON LABORATORIES, INC.] 6 DEXAMETHASONE ACTIVE MOIETY 7S5I7G3JQL TOBRADEX ST (TOBRAMYCIN / DEXAMETHASONE) SUSPENSION [ALCON LABORATORIES, INC.] 6 TOBRAMYCIN ACTIVE MOIETY VZ8RRZ51VK TOBRADEX ST (TOBRAMYCIN / DEXAMETHASONE) SUSPENSION [ALCON LABORATORIES, INC.] 6 BENZALKONIUM CHLORIDE INACTIVE INGREDIENT F5UM2KM3W7 TOBRADEX ST (TOBRAMYCIN / DEXAMETHASONE) SUSPENSION [ALCON LABORATORIES, INC.] 6 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K TOBRADEX ST (TOBRAMYCIN / DEXAMETHASONE) SUSPENSION [ALCON LABORATORIES, INC.] 6 HYDROCHLORIC ACID INACTIVE INGREDIENT QTT17582CB TOBRADEX ST (TOBRAMYCIN / DEXAMETHASONE) SUSPENSION [ALCON LABORATORIES, INC.] 6 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 TOBRADEX ST (TOBRAMYCIN / DEXAMETHASONE) SUSPENSION [ALCON LABORATORIES, INC.] 6 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X TOBRADEX ST (TOBRAMYCIN / DEXAMETHASONE) SUSPENSION [ALCON LABORATORIES, INC.] 6 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I TOBRADEX ST (TOBRAMYCIN / DEXAMETHASONE) SUSPENSION [ALCON LABORATORIES, INC.] 6 SODIUM SULFATE INACTIVE INGREDIENT 0YPR65R21J TOBRADEX ST (TOBRAMYCIN / DEXAMETHASONE) SUSPENSION [ALCON LABORATORIES, INC.] 6 TYLOXAPOL INACTIVE INGREDIENT Y27PUL9H56 TOBRADEX ST (TOBRAMYCIN / DEXAMETHASONE) SUSPENSION [ALCON LABORATORIES, INC.] 6 WATER INACTIVE INGREDIENT 059QF0KO0R TOBRADEX ST (TOBRAMYCIN / DEXAMETHASONE) SUSPENSION [ALCON LABORATORIES, INC.] 6 XANTHAN GUM INACTIVE INGREDIENT TTV12P4NEE TOBRADEX ST (TOBRAMYCIN / DEXAMETHASONE) SUSPENSION [ALCON LABORATORIES, INC.] 6
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0065-0652-05 00065065205 1 BOTTLE, DROPPER in 1 CARTON (0065-0652-05) > 5 mL in 1 BOTTLE, DROPPER 2010-09-07 2021-06-30 No No Current