TOBRADEX ST

Product NDC: 0065-0652
Requested package NDC: 0065-0652-05
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

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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	0065-0652	0065-0652-05	D	Discontinued by firm		2026-10-05

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N050818-001	TOBRADEX ST	0.05%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2009-02-13	`84e616aacf4f…`
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…`

Observed Orange Book patent history#

Patent history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N050818-001	8101582	2027-12-19	U-1082	Drug product	2012-09-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N050818-001	8450287	2027-12-19		Drug product	2016-02-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N050818-001	7795316	2028-08-03	U-1082	Drug product	2010-09-30	`84e616aacf4f…`
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…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0065-0652-05	ML - Milliliter	0065-0652	711a3ed1-5cac-412c-890d-f3dbab4c638c	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tobradex ST	TOBRAMYCIN / DEXAMETHASONE	Harrow Eye, LLC	3b99dbb3-ac84-4d0d-b30f-a5db44fdc316	2025-04-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 050818 application number: NDA050818
Tobradex ST	TOBRAMYCIN / DEXAMETHASONE	Eyevance Pharmaceuticals, LLC	c2d7325e-4f58-5590-e053-2a95a90ace1b	2025-01-16	Warnings, Adverse reactions	Exact identifier application applno (NDA): 050818 application number: NDA050818

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
VZ8RRZ51VK	TOBRAMYCIN	32986-56-4	TOBRAMYCIN
7S5I7G3JQL	DEXAMETHASONE	50-02-2	DEXAMETHASONE

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