Brimonidine Tartrate/Timolol Maleate

Product NDC: 0591-2422
Requested package NDC: 0591-2422-79
11-digit product format: 005912422
Labeler code: 0591
Product ID: 0591-2422_1d48bdb8-e47a-4716-a13a-49482fd45b5e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Brimonidine Tartrate and Timolol Maleate
Dosage form: SOLUTION/ DROPS
Route: OPHTHALMIC
Labeler: Actavis Pharma, Inc.
Application: ANDA201949
Marketing category: ANDA
Marketing start: 2022-10-07
Marketing end: 0000-00-00
Substance: BRIMONIDINE TARTRATE; TIMOLOL MALEATE
Active strength: 2 mg/mL; mg/mL
Pharmacologic classes: Adrenergic alpha-Agonists [MoA], Adrenergic beta-Antagonists [MoA], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Blocker [EPC]
NDC exclude flag: No
Listing certified through: 2023-12-31
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	0591-2422	0591-2422-79	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 · 9 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…`

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
A201949-001	BRIMONIDINE TARTRATE AND TIMOLOL MALEATE	BRIMONIDINE TARTRATE; TIMOLOL MALEATE	0.2%;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AB		2022-10-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A201949-001	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A201949-001	BRIMONIDINE TARTRATE AND TIMOLOL MALEATE	0.2%;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AB	2022-10-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201949-001	BRIMONIDINE TARTRATE AND TIMOLOL MALEATE	0.2%;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AB	2022-10-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201949-001	BRIMONIDINE TARTRATE AND TIMOLOL MALEATE	0.2%;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AB	2022-10-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201949-001	BRIMONIDINE TARTRATE AND TIMOLOL MALEATE	0.2%;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AB	2022-10-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201949-001	BRIMONIDINE TARTRATE AND TIMOLOL MALEATE	0.2%;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AB	2022-10-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201949-001	BRIMONIDINE TARTRATE AND TIMOLOL MALEATE	0.2%;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AB	2022-10-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201949-001	BRIMONIDINE TARTRATE AND TIMOLOL MALEATE	0.2%;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AB	2022-10-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201949-001	BRIMONIDINE TARTRATE AND TIMOLOL MALEATE	0.2%;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AB	2022-10-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201949-001	BRIMONIDINE TARTRATE AND TIMOLOL MALEATE	0.2%;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AB	2022-10-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201949-001	BRIMONIDINE TARTRATE AND TIMOLOL MALEATE	0.2%;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AB	2022-10-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201949-001	BRIMONIDINE TARTRATE AND TIMOLOL MALEATE	0.2%;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AB	2022-10-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201949-001	BRIMONIDINE TARTRATE AND TIMOLOL MALEATE	0.2%;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AB	2022-10-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201949-001	BRIMONIDINE TARTRATE AND TIMOLOL MALEATE	0.2%;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AB	2022-10-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201949-001	BRIMONIDINE TARTRATE AND TIMOLOL MALEATE	0.2%;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AB	2022-10-04	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A201949-001	BRIMONIDINE TARTRATE AND TIMOLOL MALEATE	0.2%;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AB	2022-10-04	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A201949-001	BRIMONIDINE TARTRATE AND TIMOLOL MALEATE	0.2%;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AB	2022-10-04	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A201949-001	BRIMONIDINE TARTRATE AND TIMOLOL MALEATE	0.2%;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AB	2022-10-04	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A201949-001	BRIMONIDINE TARTRATE AND TIMOLOL MALEATE	0.2%;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AB	2022-10-04	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A201949-001	BRIMONIDINE TARTRATE AND TIMOLOL MALEATE	0.2%;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AB	2022-10-04	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A201949-001	BRIMONIDINE TARTRATE AND TIMOLOL MALEATE	0.2%;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AB	2022-10-04	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A201949-001	BRIMONIDINE TARTRATE AND TIMOLOL MALEATE	0.2%;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AB	2022-10-04	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A201949-001	BRIMONIDINE TARTRATE AND TIMOLOL MALEATE	0.2%;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AB	2022-10-04	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A201949-001	BRIMONIDINE TARTRATE AND TIMOLOL MALEATE	0.2%;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AB	2022-10-04	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A201949-001	BRIMONIDINE TARTRATE AND TIMOLOL MALEATE	0.2%;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AB	2022-10-04	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A201949-001	BRIMONIDINE TARTRATE AND TIMOLOL MALEATE	0.2%;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AB	2022-10-04	`f41ea6bd6efb…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A201949-001	BRIMONIDINE TARTRATE AND TIMOLOL MALEATE	0.2%;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AB	2022-10-04	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A201949-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201949-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201949-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201949-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201949-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201949-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201949-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201949-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201949-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201949-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201949-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201949-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201949-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201949-001	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A201949-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A201949-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A201949-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A201949-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A201949-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A201949-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A201949-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A201949-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A201949-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A201949-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A201949-001	AB	1	`f41ea6bd6efb…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A201949-001	AB	1	`a50c72e98297…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0591-2422-12	ML - Milliliter	0591-2422	d7761cb9-134e-483f-b16f-82155a58cc64	1	2022-11-07
0591-2422-26	ML - Milliliter	0591-2422	2be79a08-6d56-4d47-b63f-cfbc1af5015d	1	2022-11-07
0591-2422-79	ML - Milliliter	0591-2422	5cb66cba-1c99-42fa-bf49-f4135a042d5d	1	2022-11-07

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
BRIMONIDINE TARTRATE AND TIMOLOL MALEATE	BRIMONIDINE TARTRATE AND TIMOLOL MALEATE	Florida Pharmaceutical Products, LLC	7011a203-46cf-434d-ba11-253f107ff80f	2026-05-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201949 application number: ANDA201949
Brimonidine tartrate and Timolol maleate	BRIMONIDINE TARTRATE AND TIMOLOL MALEATE	NorthStar RxLLC	be282a72-0797-449d-ae07-fb8d4bdcc0a5	2026-04-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201949 application number: ANDA201949
Brimonidine Tartrate/Timolol Maleate	BRIMONIDINE TARTRATE AND TIMOLOL MALEATE	ARMAS PHARMACEUTICALS INC	09476aab-0816-812c-e063-6394a90a12a2	2023-11-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201949 application number: ANDA201949

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
4S9CL2DY2H	BRIMONIDINE TARTRATE	70359-46-5	BRIMONIDINE TARTRATE
P8Y54F701R	TIMOLOL MALEATE	26921-17-5	TIMOLOL MALEATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0591-2422-79	00591242279	1 BOTTLE, DROPPER in 1 CARTON (0591-2422-79) > 10 mL in 1 BOTTLE, DROPPER	2022-10-07	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Brimonidine Tartrate/Timolol Maleate	Actavis Pharma, Inc.	2022-02-02	HUMAN PRESCRIPTION DRUG LABEL	10