SIMBRINZA

Product NDC: 0078-0904
11-digit product format: 000780904
Labeler code: 0078
Product ID: 0078-0904_c2a9e73d-9414-489a-9840-aa8aae4cdd00
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: brinzolamide/brimonidine tartrate
Dosage form: SUSPENSION/ DROPS
Route: OPHTHALMIC
Labeler: Novartis Pharmaceuticals Corporation
Application: NDA204251
Marketing category: NDA
Marketing start: 2013-05-01
Marketing end: 2023-02-28
Substance: BRIMONIDINE TARTRATE; BRINZOLAMIDE
Active strength: 2 mg/mL; mg/mL
Pharmacologic classes: Adrenergic alpha-Agonists [MoA], Carbonic Anhydrase Inhibitor [EPC], Carbonic Anhydrase Inhibitors [MoA], alpha-Adrenergic Agonist [EPC]
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	0078-0904		D	Discontinued by firm	2026-08-03
excluded package	package	0078-0904	0078-0904-38	D	Discontinued by firm	2026-08-03
excluded package	package	0078-0904	0078-0904-98	D	Discontinued by firm	2026-08-03

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 · 36 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	0078-0904-98	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0078-0904-38	`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	0078-0904-98	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0078-0904-38	`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	0078-0904-98	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0078-0904-38	`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	0078-0904-98	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0078-0904-38	`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	0078-0904-98	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0078-0904-38	`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	0078-0904-98	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0078-0904-38	`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	0078-0904-98	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0078-0904-38	`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	0078-0904-98	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0078-0904-38	`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	0078-0904-98	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0078-0904-38	`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	0078-0904-98	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0078-0904-38	`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	0078-0904-98	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0078-0904-38	`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	0078-0904-98	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0078-0904-38	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
N204251-001	SIMBRINZA	BRIMONIDINE TARTRATE; BRINZOLAMIDE	0.2%;1%	SUSPENSION/DROPS / OPHTHALMIC		RLD, RS	2013-04-19

Orange Book patents#

Current patent rows page 1 of 1 · 2 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N204251-001	9421265	2030-06-17		Drug product	2016-10-24
N204251-001	9044484	2030-10-30		Drug product	2015-06-09

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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N204251-001	SIMBRINZA	0.2%;1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2013-04-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204251-001	SIMBRINZA	0.2%;1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2013-04-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N204251-001	SIMBRINZA	0.2%;1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2013-04-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204251-001	SIMBRINZA	0.2%;1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2013-04-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204251-001	SIMBRINZA	0.2%;1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2013-04-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204251-001	SIMBRINZA	0.2%;1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2013-04-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204251-001	SIMBRINZA	0.2%;1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2013-04-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204251-001	SIMBRINZA	0.2%;1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2013-04-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204251-001	SIMBRINZA	0.2%;1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2013-04-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N204251-001	SIMBRINZA	0.2%;1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2013-04-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N204251-001	SIMBRINZA	0.2%;1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2013-04-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N204251-001	SIMBRINZA	0.2%;1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2013-04-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N204251-001	SIMBRINZA	0.2%;1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2013-04-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N204251-001	SIMBRINZA	0.2%;1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2013-04-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N204251-001	SIMBRINZA	0.2%;1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2013-04-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N204251-001	SIMBRINZA	0.2%;1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2013-04-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N204251-001	SIMBRINZA	0.2%;1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2013-04-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N204251-001	SIMBRINZA	0.2%;1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2013-04-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N204251-001	SIMBRINZA	0.2%;1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2013-04-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N204251-001	SIMBRINZA	0.2%;1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2013-04-19	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N204251-001	SIMBRINZA	0.2%;1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2013-04-19	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N204251-001	SIMBRINZA	0.2%;1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2013-04-19	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N204251-001	SIMBRINZA	0.2%;1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2013-04-19	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N204251-001	SIMBRINZA	0.2%;1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2013-04-19	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N204251-001	SIMBRINZA	0.2%;1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2013-04-19	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N204251-001	SIMBRINZA	0.2%;1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2013-04-19	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N204251-001	SIMBRINZA	0.2%;1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2013-04-19	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N204251-001	SIMBRINZA	0.2%;1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2013-04-19	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N204251-001	SIMBRINZA	0.2%;1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2013-04-19	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N204251-001	SIMBRINZA	0.2%;1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2013-04-19	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N204251-001	SIMBRINZA	0.2%;1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2013-04-19	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N204251-001	SIMBRINZA	0.2%;1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2013-04-19	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N204251-001	SIMBRINZA	0.2%;1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2013-04-19	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N204251-001	SIMBRINZA	0.2%;1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2013-04-19	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N204251-001	SIMBRINZA	0.2%;1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2013-04-19	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N204251-001	SIMBRINZA	0.2%;1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2013-04-19	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N204251-001	SIMBRINZA	0.2%;1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2013-04-19	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N204251-001	SIMBRINZA	0.2%;1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2013-04-19	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N204251-001	SIMBRINZA	0.2%;1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2013-04-19	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N204251-001	SIMBRINZA	0.2%;1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2013-04-19	`cb3db0bc1861…`

Observed Orange Book patent history#

Patent history page 1 of 3 · 86 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	N204251-001	9421265	2030-06-17		Drug product	2016-10-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204251-001	9044484	2030-10-30		Drug product	2015-06-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204251-001	9421265	2030-06-17		Drug product	2016-10-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204251-001	9044484	2030-10-30		Drug product	2015-06-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N204251-001	9421265	2030-06-17		Drug product	2016-10-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204251-001	9044484	2030-10-30		Drug product	2015-06-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204251-001	9421265	2030-06-17		Drug product	2016-10-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204251-001	9044484	2030-10-30		Drug product	2015-06-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204251-001	9421265	2030-06-17		Drug product	2016-10-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204251-001	9044484	2030-10-30		Drug product	2015-06-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204251-001	9421265	2030-06-17		Drug product	2016-10-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204251-001	9044484	2030-10-30		Drug product	2015-06-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204251-001	9421265	2030-06-17		Drug product	2016-10-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204251-001	9044484	2030-10-30		Drug product	2015-06-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204251-001	9421265	2030-06-17		Drug product	2016-10-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204251-001	9044484	2030-10-30		Drug product	2015-06-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204251-001	9421265	2030-06-17		Drug product	2016-10-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204251-001	9044484	2030-10-30		Drug product	2015-06-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N204251-001	9421265	2030-06-17		Drug product	2016-10-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N204251-001	9044484	2030-10-30		Drug product	2015-06-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N204251-001	9421265	2030-06-17		Drug product	2016-10-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N204251-001	9044484	2030-10-30		Drug product	2015-06-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N204251-001	9421265	2030-06-17		Drug product	2016-10-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N204251-001	9044484	2030-10-30		Drug product	2015-06-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N204251-001	9421265	2030-06-17		Drug product	2016-10-24	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N204251-001	9044484	2030-10-30		Drug product	2015-06-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N204251-001	9421265	2030-06-17		Drug product	2016-10-24	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N204251-001	9044484	2030-10-30		Drug product	2015-06-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N204251-001	9421265	2030-06-17		Drug product	2016-10-24	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N204251-001	9044484	2030-10-30		Drug product	2015-06-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N204251-001	9421265	2030-06-17		Drug product	2016-10-24	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N204251-001	9044484	2030-10-30		Drug product	2015-06-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N204251-001	9421265	2030-06-17		Drug product	2016-10-24	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N204251-001	9044484	2030-10-30		Drug product	2015-06-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N204251-001	6316441	2019-12-07	U-778		2013-09-13	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N204251-001	9421265	2030-06-17		Drug product	2016-10-24	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N204251-001	9044484	2030-10-30		Drug product	2015-06-09	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N204251-001	9421265	2030-06-17		Drug product	2016-10-24	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N204251-001	9044484	2030-10-30		Drug product	2015-06-09	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N204251-001	9421265	2030-06-17		Drug product	2016-10-24	`782e0a99824c…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SIMBRINZA	BRINZOLAMIDE/BRIMONIDINE TARTRATE	Alcon Laboratories, Inc.	a49c157e-6310-0011-7b7f-e26fc1820d59	2025-03-11	Warnings, Adverse reactions	Exact identifier application applno (NDA): 204251 application number: NDA204251

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
4S9CL2DY2H	BRIMONIDINE TARTRATE	70359-46-5	BRIMONIDINE TARTRATE
9451Z89515	BRINZOLAMIDE	138890-62-7	BRINZOLAMIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0078-0904-38	00078090438	1 BOTTLE in 1 CARTON (0078-0904-38) > 8 mL in 1 BOTTLE	1 bottle	2020-08-04	0000-00-00	No	No	Current
0078-0904-98	00078090498	1 BOTTLE in 1 CARTON (0078-0904-98) > 2.5 mL in 1 BOTTLE	1 bottle	2020-08-04	0000-00-00	Yes	No	Current