Tobramycin and Dexamethasone

Product NDC: 52959-984
11-digit product format: 529590984
Labeler code: 52959
Product ID: 52959-984_fb0e30f7-a594-40cf-b56c-a45cfbcd60d8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Tobramycin and Dexamethasone
Dosage form: SUSPENSION
Route: OPHTHALMIC
Labeler: H.J. Harkins Company, Inc.
Application: NDA050592
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2009-01-02
Marketing end: 0000-00-00
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: E
Listing certified through: 2017-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	52959-984		I	Inactivated by FDA	2026-08-17
excluded package	package	52959-984	52959-984-05	I	Inactivated by FDA	2026-08-17
excluded package	package	52959-984	52959-984-10	I	Inactivated by FDA	2026-08-17

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 2 · 66 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-984-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-984-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-984-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-984-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-984-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-984-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-984-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-984-05	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52959-984-10	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52959-984-05	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	52959-984-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	52959-984-05	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	52959-984-10	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	52959-984-05	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	52959-984-10	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	52959-984-05	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	52959-984-10	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	52959-984-05	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	52959-984-10	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	52959-984-05	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	52959-984-10	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	52959-984-05	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	52959-984-10	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	52959-984-05	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	52959-984-10	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	52959-984-05	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	52959-984-10	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	52959-984-05	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	52959-984-10	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	52959-984-05	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	52959-984-10	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	52959-984-05	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	52959-984-10	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	52959-984-05	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	52959-984-10	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	52959-984-05	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	52959-984-10	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	52959-984-05	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	52959-984-10	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	52959-984-05	`e2bbac7714bc…`	`27bdfed8d636…`

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
N050592-001	TOBRADEX	DEXAMETHASONE; TOBRAMYCIN	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1988-08-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N050592-001	AB

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	N050592-001	TOBRADEX	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1988-08-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N050592-001	TOBRADEX	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1988-08-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050592-001	TOBRADEX	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1988-08-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050592-001	TOBRADEX	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1988-08-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050592-001	TOBRADEX	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1988-08-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050592-001	TOBRADEX	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1988-08-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050592-001	TOBRADEX	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1988-08-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050592-001	TOBRADEX	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1988-08-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050592-001	TOBRADEX	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1988-08-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050592-001	TOBRADEX	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1988-08-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050592-001	TOBRADEX	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1988-08-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050592-001	TOBRADEX	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1988-08-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050592-001	TOBRADEX	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1988-08-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050592-001	TOBRADEX	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1988-08-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050592-001	TOBRADEX	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1988-08-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050592-001	TOBRADEX	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1988-08-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050592-001	TOBRADEX	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1988-08-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050592-001	TOBRADEX	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1988-08-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N050592-001	TOBRADEX	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1988-08-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N050592-001	TOBRADEX	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1988-08-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N050592-001	TOBRADEX	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1988-08-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050592-001	TOBRADEX	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1988-08-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N050592-001	TOBRADEX	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1988-08-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N050592-001	TOBRADEX	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1988-08-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N050592-001	TOBRADEX	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1988-08-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N050592-001	TOBRADEX	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1988-08-18	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N050592-001	TOBRADEX	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1988-08-18	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N050592-001	TOBRADEX	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1988-08-18	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N050592-001	TOBRADEX	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1988-08-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N050592-001	TOBRADEX	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1988-08-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N050592-001	TOBRADEX	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1988-08-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N050592-001	TOBRADEX	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1988-08-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N050592-001	TOBRADEX	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1988-08-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N050592-001	TOBRADEX	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1988-08-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N050592-001	TOBRADEX	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1988-08-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N050592-001	TOBRADEX	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1988-08-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N050592-001	TOBRADEX	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1988-08-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N050592-001	TOBRADEX	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1988-08-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N050592-001	TOBRADEX	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1988-08-18	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N050592-001	TOBRADEX	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1988-08-18	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N050592-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N050592-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050592-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050592-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050592-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050592-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050592-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050592-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050592-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050592-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050592-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050592-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050592-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050592-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050592-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050592-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050592-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050592-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N050592-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N050592-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N050592-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050592-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N050592-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N050592-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N050592-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N050592-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N050592-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N050592-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N050592-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N050592-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N050592-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N050592-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N050592-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N050592-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N050592-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N050592-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N050592-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N050592-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N050592-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N050592-001	AB	1	`e64feba35796…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
1ea46721-9071-6b81-fd0a-a82bfbb014ec	Product name	7	20250220
525701df-f985-480d-995a-e0ee70c2bdf4	Product name	5	20250128
f297c7c1-845a-4369-8c02-c51b92d6ae8e	Product name	3	20240725
ea50b939-d92a-4100-84f5-1c1089663837	Product name	2	20240705
551d952d-4ce2-24f0-9ab0-630ad9aae596	Product name	2	20231211
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
941f67d9-7f03-56d2-750c-36de24f654db	Product name	3	20221117
d7d46a10-8766-d3c8-ebf2-2ccd9efdcae8	Product name	2	20220506
7b2c58e8-5850-4e3e-82e9-b1593b1de761	Product name	5	20220210
9cfa145f-dbe9-bc02-83c2-692786ef6676	Product name	9	20210928
2f9713b8-5e7e-bbcc-b364-1b2c27a63796	Product name	4	20210903
32a533bc-01c7-2b9f-bbf7-ecfb0d964277	Product name	4	20210625
81e34474-b0a5-434f-8104-25d689efc99e	Product name	1	20200303
05ab9c01-cd9a-4f59-b2e8-ddcb887cac39	Product name	1	20190408
0c7dba41-c919-5809-508d-4affe6cfcff2	Product name	2	20170817
9f5124fb-08b0-4c3e-8e12-a1a6ff310cba	Product name	1	20150309
399647c0-db89-02d1-991c-0c17b584482c	Product name	1	20140508
3e9a6377-704f-dff7-b19f-56c98d40c444	Product name	1	20140508
4d2e6ff9-14f5-b84f-c39b-373b005712c1	Product name	1	20140508
725d71bf-f956-5cad-e556-fa39cb060dc8	Product name	1	20140508
745a62af-e1c0-4ca3-6d6e-2b6455b903be	Product name	1	20140508
9ea85abb-fa68-5da6-ab60-2c7eef579000	Product name	1	20140508
aa1cd319-ece7-51f7-3a9d-52a64f5f4e81	Product name	1	20140508
d029211e-5e6b-725f-3696-ac6ff77da222	Product name	1	20140508
ef5b7aed-2b01-3ba8-5a1c-3bc9c9f03bb1	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
52959-984-05	2019-11-13	C162847	48780-1	97449f38-cd13-f6ea-e053-dbdaa90aa703	Tobramycin and Dexamethasone Ophthalmic Suspension Sterile
52959-984-10	2019-11-13	C162847	48780-1	97449f38-cd13-f6ea-e053-dbdaa90aa703	Tobramycin and Dexamethasone Ophthalmic Suspension Sterile

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
52959-984-05	Tobramycin and Dexamethasone	5 mL in 1 BOTTLE	SUSPENSION	5		2
52959-984-10	Tobramycin and Dexamethasone	10 mL in 1 BOTTLE	SUSPENSION	10		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
52959-984-10	ML - Milliliter	52959-984	c61fb745-7464-469b-b1c3-d1074f96ab41	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DEXAMETHASONE	ACTIVE INGREDIENT	7S5I7G3JQL	TOBRAMYCIN AND DEXAMETHASONE SUSPENSION [H.J. HARKINS COMPANY, INC.]	2
TOBRAMYCIN	ACTIVE INGREDIENT	VZ8RRZ51VK	TOBRAMYCIN AND DEXAMETHASONE SUSPENSION [H.J. HARKINS COMPANY, INC.]	2
DEXAMETHASONE	ACTIVE MOIETY	7S5I7G3JQL	TOBRAMYCIN AND DEXAMETHASONE SUSPENSION [H.J. HARKINS COMPANY, INC.]	2
TOBRAMYCIN	ACTIVE MOIETY	VZ8RRZ51VK	TOBRAMYCIN AND DEXAMETHASONE SUSPENSION [H.J. HARKINS COMPANY, INC.]	2
BENZALKONIUM CHLORIDE	INACTIVE INGREDIENT	F5UM2KM3W7	TOBRAMYCIN AND DEXAMETHASONE SUSPENSION [H.J. HARKINS COMPANY, INC.]	2
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	TOBRAMYCIN AND DEXAMETHASONE SUSPENSION [H.J. HARKINS COMPANY, INC.]	2
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)	INACTIVE INGREDIENT	S38J6RZN16	TOBRAMYCIN AND DEXAMETHASONE SUSPENSION [H.J. HARKINS COMPANY, INC.]	2
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	TOBRAMYCIN AND DEXAMETHASONE SUSPENSION [H.J. HARKINS COMPANY, INC.]	2
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	TOBRAMYCIN AND DEXAMETHASONE SUSPENSION [H.J. HARKINS COMPANY, INC.]	2
SODIUM SULFATE	INACTIVE INGREDIENT	0YPR65R21J	TOBRAMYCIN AND DEXAMETHASONE SUSPENSION [H.J. HARKINS COMPANY, INC.]	2
SULFURIC ACID	INACTIVE INGREDIENT	O40UQP6WCF	TOBRAMYCIN AND DEXAMETHASONE SUSPENSION [H.J. HARKINS COMPANY, INC.]	2
TYLOXAPOL	INACTIVE INGREDIENT	Y27PUL9H56	TOBRAMYCIN AND DEXAMETHASONE SUSPENSION [H.J. HARKINS COMPANY, INC.]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	TOBRAMYCIN AND DEXAMETHASONE SUSPENSION [H.J. HARKINS COMPANY, INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52959-984	TOBRAMYCIN AND DEXAMETHASONE SUSPENSION [H.J. HARKINS COMPANY, INC.]	2	Legacy NDC, 2 package rows	20111215_8f7f1b78-8ac3-4ba5-b0ec-ca87a433ad39.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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tobramycin and Dexamethasone	TOBRAMYCIN AND DEXAMETHASONE	REMEDYREPACK INC.	c606945c-4ffc-4ee8-af04-a00de8ea9259	2026-06-11	Warnings, Adverse reactions	Exact identifier application applno (NDA): 050592 application number: NDA050592
Tobramycin and Dexamethasone	TOBRAMYCIN AND DEXAMETHASONE	Preferred Pharmaceuticals Inc.	8a143864-e36b-49bf-91b4-c6cc1a928031	2026-02-26	Warnings, Adverse reactions	Exact identifier application applno (NDA): 050592 application number: NDA050592
Tobramycin and Dexamethasone	TOBRAMYCIN AND DEXAMETHASONE	Sandoz Inc	05fd0c36-39b4-4a43-8490-eb8dfc0920ae	2025-04-07	Warnings, Adverse reactions	Exact identifier application applno (NDA): 050592 application number: NDA050592
Tobramycin and Dexamethasone	TOBRAMYCIN AND DEXAMETHASONE	Advanced Rx of Tennessee, LLC	09315f0b-f15a-30d5-e063-6394a90ac8dd	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (NDA): 050592 application number: NDA050592
Tobramycin and Dexamethasone	TOBRAMYCIN AND DEXAMETHASONE	A-S Medication Solutions	11c2ba9a-7aa3-4f78-aa2f-2a35d2671681	2024-08-12	Warnings, Adverse reactions	Exact identifier application applno (NDA): 050592 application number: NDA050592
Tobramycin and Dexamethasone	TOBRAMYCIN AND DEXAMETHASONE	A-S Medication Solutions	e4ddce2f-1b91-46e1-a8f0-a38394d4e672	2023-07-11	Warnings, Adverse reactions	Exact identifier application applno (NDA): 050592 application number: NDA050592

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
309683	tobramycin 0.3 % / dexAMETHasone 0.1 % Ophthalmic Suspension	PSN	8f7f1b78-8ac3-4ba5-b0ec-ca87a433ad39	2
309683	dexamethasone 1 MG/ML / tobramycin 3 MG/ML Ophthalmic Suspension	SCD	8f7f1b78-8ac3-4ba5-b0ec-ca87a433ad39	2
309683	dexamethasone 0.1 % / tobramycin 0.3 % Ophthalmic Suspension	SY	8f7f1b78-8ac3-4ba5-b0ec-ca87a433ad39	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
52959-984-05	52959098405	5 mL in 1 BOTTLE	5 ml	Historical
52959-984-10	52959098410	10 mL in 1 BOTTLE	10 ml	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Tobramycin and Dexamethasone Ophthalmic Suspension Sterile	H.J. Harkins Company, Inc. \| Falcon Pharmaceuticals \| Alcon Laboratories, Inc.	2011-12-14	HUMAN PRESCRIPTION DRUG LABEL	2