Brimonidine Tartrate

Product NDC: 50090-4224
Requested package NDC: 50090-4224-0
11-digit product format: 500904224
Labeler code: 50090
Product ID: 50090-4224_bf8ef42e-c465-4e70-ac5b-edd96463c833
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Brimonidine Tartrate
Dosage form: SOLUTION
Route: OPHTHALMIC
Labeler: A-S Medication Solutions
Application: ANDA076254
Marketing category: ANDA
Marketing start: 2003-09-17
Marketing end: 0000-00-00
Substance: BRIMONIDINE TARTRATE
Active strength: 2 mg/mL
Pharmacologic classes: Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC]
NDC exclude flag: No
Listing certified through: 2022-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	50090-4224	50090-4224-0	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 1 · 15 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…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`

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
A076254-001	BRIMONIDINE TARTRATE	BRIMONIDINE TARTRATE	0.2%	SOLUTION/DROPS / OPHTHALMIC	AT		2003-09-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076254-001	AT

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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A076254-001	BRIMONIDINE TARTRATE	0.2%	SOLUTION/DROPS / OPHTHALMIC	AT	2003-09-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076254-001	BRIMONIDINE TARTRATE	0.2%	SOLUTION/DROPS / OPHTHALMIC	AT	2003-09-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076254-001	BRIMONIDINE TARTRATE	0.2%	SOLUTION/DROPS / OPHTHALMIC	AT	2003-09-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076254-001	BRIMONIDINE TARTRATE	0.2%	SOLUTION/DROPS / OPHTHALMIC	AT	2003-09-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076254-001	BRIMONIDINE TARTRATE	0.2%	SOLUTION/DROPS / OPHTHALMIC	AT	2003-09-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076254-001	BRIMONIDINE TARTRATE	0.2%	SOLUTION/DROPS / OPHTHALMIC	AT	2003-09-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076254-001	BRIMONIDINE TARTRATE	0.2%	SOLUTION/DROPS / OPHTHALMIC	AT	2003-09-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076254-001	BRIMONIDINE TARTRATE	0.2%	SOLUTION/DROPS / OPHTHALMIC	AT	2003-09-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076254-001	BRIMONIDINE TARTRATE	0.2%	SOLUTION/DROPS / OPHTHALMIC	AT	2003-09-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076254-001	BRIMONIDINE TARTRATE	0.2%	SOLUTION/DROPS / OPHTHALMIC	AT	2003-09-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076254-001	BRIMONIDINE TARTRATE	0.2%	SOLUTION/DROPS / OPHTHALMIC	AT	2003-09-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076254-001	BRIMONIDINE TARTRATE	0.2%	SOLUTION/DROPS / OPHTHALMIC	AT	2003-09-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076254-001	BRIMONIDINE TARTRATE	0.2%	SOLUTION/DROPS / OPHTHALMIC	AT	2003-09-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076254-001	BRIMONIDINE TARTRATE	0.2%	SOLUTION/DROPS / OPHTHALMIC	AT	2003-09-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076254-001	BRIMONIDINE TARTRATE	0.2%	SOLUTION/DROPS / OPHTHALMIC	AT	2003-09-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076254-001	BRIMONIDINE TARTRATE	0.2%	SOLUTION/DROPS / OPHTHALMIC	AT	2003-09-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076254-001	BRIMONIDINE TARTRATE	0.2%	SOLUTION/DROPS / OPHTHALMIC	AT	2003-09-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076254-001	BRIMONIDINE TARTRATE	0.2%	SOLUTION/DROPS / OPHTHALMIC	AT	2003-09-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076254-001	BRIMONIDINE TARTRATE	0.2%	SOLUTION/DROPS / OPHTHALMIC	AT	2003-09-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076254-001	BRIMONIDINE TARTRATE	0.2%	SOLUTION/DROPS / OPHTHALMIC	AT	2003-09-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076254-001	BRIMONIDINE TARTRATE	0.2%	SOLUTION/DROPS / OPHTHALMIC	AT	2003-09-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076254-001	BRIMONIDINE TARTRATE	0.2%	SOLUTION/DROPS / OPHTHALMIC	AT	2003-09-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076254-001	BRIMONIDINE TARTRATE	0.2%	SOLUTION/DROPS / OPHTHALMIC	AT	2003-09-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076254-001	BRIMONIDINE TARTRATE	0.2%	SOLUTION/DROPS / OPHTHALMIC	AT	2003-09-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076254-001	BRIMONIDINE TARTRATE	0.2%	SOLUTION/DROPS / OPHTHALMIC	AT	2003-09-16	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076254-001	BRIMONIDINE TARTRATE	0.2%	SOLUTION/DROPS / OPHTHALMIC	AT	2003-09-16	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076254-001	BRIMONIDINE TARTRATE	0.2%	SOLUTION/DROPS / OPHTHALMIC	AT	2003-09-16	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076254-001	BRIMONIDINE TARTRATE	0.2%	SOLUTION/DROPS / OPHTHALMIC	AT	2003-09-16	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076254-001	BRIMONIDINE TARTRATE	0.2%	SOLUTION/DROPS / OPHTHALMIC	AT	2003-09-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076254-001	BRIMONIDINE TARTRATE	0.2%	SOLUTION/DROPS / OPHTHALMIC	AT	2003-09-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076254-001	BRIMONIDINE TARTRATE	0.2%	SOLUTION/DROPS / OPHTHALMIC	AT	2003-09-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076254-001	BRIMONIDINE TARTRATE	0.2%	SOLUTION/DROPS / OPHTHALMIC	AT	2003-09-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076254-001	BRIMONIDINE TARTRATE	0.2%	SOLUTION/DROPS / OPHTHALMIC	AT	2003-09-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076254-001	BRIMONIDINE TARTRATE	0.2%	SOLUTION/DROPS / OPHTHALMIC	AT	2003-09-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076254-001	BRIMONIDINE TARTRATE	0.2%	SOLUTION/DROPS / OPHTHALMIC	AT	2003-09-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076254-001	BRIMONIDINE TARTRATE	0.2%	SOLUTION/DROPS / OPHTHALMIC	AT	2003-09-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076254-001	BRIMONIDINE TARTRATE	0.2%	SOLUTION/DROPS / OPHTHALMIC	AT	2003-09-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076254-001	BRIMONIDINE TARTRATE	0.2%	SOLUTION/DROPS / OPHTHALMIC	AT	2003-09-16	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076254-001	BRIMONIDINE TARTRATE	0.2%	SOLUTION/DROPS / OPHTHALMIC	AT	2003-09-16	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076254-001	BRIMONIDINE TARTRATE	0.2%	SOLUTION/DROPS / OPHTHALMIC	AT	2003-09-16	`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	A076254-001	AT	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076254-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076254-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076254-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076254-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076254-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076254-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076254-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076254-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076254-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076254-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076254-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076254-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076254-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076254-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076254-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076254-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076254-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076254-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076254-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076254-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076254-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076254-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076254-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076254-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076254-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076254-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076254-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076254-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076254-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076254-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076254-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076254-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076254-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076254-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076254-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076254-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076254-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076254-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076254-001	AT	1	`e64feba35796…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
c6c0c444-a6ba-2fb5-a7bc-7f0443fa5791	Product name	4	20251208
8ec6541e-9842-115f-62bf-f7c9ab3aeddb	Product name	3	20250805
39b7fcf4-8865-6d40-d24d-9b8c28bd6345	Product name	5	20250123
c93ffd9a-5bad-44d8-b5e5-16ef4d2fee72	Product name	1	20220316

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50090-4224-0	2023-01-30	C162847	48780-1	f386c649-a37d-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use BRIMONIDINE TARTRATE OPHTHALMIC SOLUTION safely and effectively. See full prescribing information for BRIMONIDINE TARTRATE OPHTHALMIC SOLUTION. BRIMONIDINE TARTRATE ophthalmic solution For Topical Ophthalmic Use Initial U.S. Approval: 1996

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50090-4224-0	Brimonidine Tartrate	5 mL in 1 BOTTLE	SOLUTION	5		6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-4224	BRIMONIDINE TARTRATE SOLUTION [A-S MEDICATION SOLUTIONS]	6	Legacy NDC, 1 package rows	20210617_7f70f916-b4f9-4552-a002-375df20712cc.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Brimonidine Tartrate	BRIMONIDINE TARTRATE	Sandoz Inc	dfd85672-fa4b-40e3-ac9c-81b8d9e4ffde	2025-05-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076254 application number: ANDA076254

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
4S9CL2DY2H	BRIMONIDINE TARTRATE	70359-46-5	BRIMONIDINE TARTRATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
861200	brimonidine tartrate 0.2 % Ophthalmic Solution	PSN	7f70f916-b4f9-4552-a002-375df20712cc	6
861200	brimonidine tartrate 2 MG/ML Ophthalmic Solution	SCD	7f70f916-b4f9-4552-a002-375df20712cc	6
861200	brimonidine tartrate 0.2 % Ophthalmic Solution	SY	7f70f916-b4f9-4552-a002-375df20712cc	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-4224-0	50090422400	5 mL in 1 BOTTLE (50090-4224-0)	5 ml	2019-03-27	0000-00-00	No	No	Current