Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution

Product NDC: 60505-0589
11-digit product format: 605050589
Labeler code: 60505
Product ID: 60505-0589_afc08ce8-3d89-644d-abdc-61a96ad5d107
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Brimonidine Tartrate and Timolol Maleate
Dosage form: SOLUTION
Route: OPHTHALMIC
Labeler: Apotex Corp.
Application: ANDA091442
Marketing category: ANDA
Marketing start: 2022-10-19
Substance: BRIMONIDINE TARTRATE; TIMOLOL MALEATE
Active strength: 2; 5 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: 2027-12-31
Current FDA listing: Yes

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
A091442-001	BRIMONIDINE TARTRATE AND TIMOLOL MALEATE	BRIMONIDINE TARTRATE; TIMOLOL MALEATE	0.2%;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AB		2022-04-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A091442-001	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	A091442-001	BRIMONIDINE TARTRATE AND TIMOLOL MALEATE	0.2%;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AB	2022-04-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091442-001	BRIMONIDINE TARTRATE AND TIMOLOL MALEATE	0.2%;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AB	2022-04-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091442-001	BRIMONIDINE TARTRATE AND TIMOLOL MALEATE	0.2%;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AB	2022-04-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091442-001	BRIMONIDINE TARTRATE AND TIMOLOL MALEATE	0.2%;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AB	2022-04-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091442-001	BRIMONIDINE TARTRATE AND TIMOLOL MALEATE	0.2%;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AB	2022-04-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091442-001	BRIMONIDINE TARTRATE AND TIMOLOL MALEATE	0.2%;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AB	2022-04-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091442-001	BRIMONIDINE TARTRATE AND TIMOLOL MALEATE	0.2%;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AB	2022-04-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091442-001	BRIMONIDINE TARTRATE AND TIMOLOL MALEATE	0.2%;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AB	2022-04-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091442-001	BRIMONIDINE TARTRATE AND TIMOLOL MALEATE	0.2%;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AB	2022-04-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091442-001	BRIMONIDINE TARTRATE AND TIMOLOL MALEATE	0.2%;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AB	2022-04-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091442-001	BRIMONIDINE TARTRATE AND TIMOLOL MALEATE	0.2%;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AB	2022-04-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091442-001	BRIMONIDINE TARTRATE AND TIMOLOL MALEATE	0.2%;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AB	2022-04-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091442-001	BRIMONIDINE TARTRATE AND TIMOLOL MALEATE	0.2%;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AB	2022-04-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091442-001	BRIMONIDINE TARTRATE AND TIMOLOL MALEATE	0.2%;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AB	2022-04-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091442-001	BRIMONIDINE TARTRATE AND TIMOLOL MALEATE	0.2%;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AB	2022-04-20	`5c6f7cd8ea54…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091442-001	BRIMONIDINE TARTRATE AND TIMOLOL MALEATE	0.2%;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AB	2022-04-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091442-001	BRIMONIDINE TARTRATE AND TIMOLOL MALEATE	0.2%;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AB	2022-04-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091442-001	BRIMONIDINE TARTRATE AND TIMOLOL MALEATE	0.2%;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AB	2022-04-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091442-001	BRIMONIDINE TARTRATE AND TIMOLOL MALEATE	0.2%;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AB	2022-04-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091442-001	BRIMONIDINE TARTRATE AND TIMOLOL MALEATE	0.2%;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AB	2022-04-20	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091442-001	BRIMONIDINE TARTRATE AND TIMOLOL MALEATE	0.2%;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AB	2022-04-20	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091442-001	BRIMONIDINE TARTRATE AND TIMOLOL MALEATE	0.2%;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AB	2022-04-20	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091442-001	BRIMONIDINE TARTRATE AND TIMOLOL MALEATE	0.2%;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AB	2022-04-20	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091442-001	BRIMONIDINE TARTRATE AND TIMOLOL MALEATE	0.2%;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AB	2022-04-20	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091442-001	BRIMONIDINE TARTRATE AND TIMOLOL MALEATE	0.2%;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AB	2022-04-20	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091442-001	BRIMONIDINE TARTRATE AND TIMOLOL MALEATE	0.2%;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AB	2022-04-20	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091442-001	BRIMONIDINE TARTRATE AND TIMOLOL MALEATE	0.2%;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AB	2022-04-20	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A091442-001	BRIMONIDINE TARTRATE AND TIMOLOL MALEATE	0.2%;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AB	2022-04-20	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A091442-001	BRIMONIDINE TARTRATE AND TIMOLOL MALEATE	0.2%;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AB	2022-04-20	`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	A091442-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091442-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091442-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091442-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091442-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091442-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091442-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091442-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091442-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091442-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091442-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091442-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091442-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091442-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091442-001	AB	1	`5c6f7cd8ea54…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091442-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091442-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091442-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091442-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091442-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091442-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091442-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091442-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091442-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091442-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091442-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091442-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A091442-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A091442-001	AB	1	`a50c72e98297…`

Additional Listing Data#

Finished product: Yes
Brand name base: Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BRIMONIDINE TARTRATE	2 mg/mL
TIMOLOL MALEATE	5 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
4S9CL2DY2H	Internal UNII lookup
P8Y54F701R	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
861635	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
268c3f6b-8798-7987-3b8c-7b7f560af5d7	Available on FDA.report

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
73103a56-9f57-4f32-a306-a42bfa2fea36	Product name	1	20250505
425025fc-f910-4afe-815b-58d4486ed4f7	Product name	4	20250331
26c5ddae-5c69-622d-e599-5fd583634968	Product name	4	20250313
ee780602-134c-4c60-a2f0-e973ba549cd4	Product name	2	20250304
726062af-1135-4707-a1d7-57256991bbf9	Product name	2	20250226
39b7fcf4-8865-6d40-d24d-9b8c28bd6345	Product name	5	20250123
03f77cb2-b4ad-3c11-8781-787b5ece4291	Product name	3	20240507
273981e4-09e7-45cc-967c-554f628ededf	Product name	3	20230627
97dad5a2-c524-a7b5-dede-82edefe9ce62	Product name	7	20220929
c93ffd9a-5bad-44d8-b5e5-16ef4d2fee72	Product name	1	20220316
d11e749b-f93e-0ce3-ceda-28fe03d8081d	Product name	2	20190731
19c71a3d-ed9c-166b-a7e5-38c250c35631	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
60505-0589-1	Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution	1 in 1 CARTON	SOLUTION	1	7
60505-0589-1	Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution	5 mL in 1 BOTTLE, DROPPER	SOLUTION	5	7
60505-0589-2	Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution	10 mL in 1 BOTTLE, DROPPER	SOLUTION	10	7
60505-0589-2	Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution	1 in 1 CARTON	SOLUTION	1	7
60505-0589-3	Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution	15 mL in 1 BOTTLE, DROPPER	SOLUTION	15	7
60505-0589-3	Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution	1 in 1 CARTON	SOLUTION	1	7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
60505-0589-1	ML - Milliliter	60505-0589	9186b46b-74f8-4d62-adce-8c5351d6a1ad	1	2022-11-07
60505-0589-2	ML - Milliliter	60505-0589	50a3e78d-b768-4cac-934a-2655860aa299	1	2022-11-07
60505-0589-3	ML - Milliliter	60505-0589	78a3ab8b-9451-407f-841a-8170ae99e241	1	2022-11-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
60505-0589	BRIMONIDINE TARTRATE/TIMOLOL MALEATE OPHTHALMIC SOLUTION (BRIMONIDINE TARTRATE AND TIMOLOL MALEATE) SOLUTION [APOTEX CORP.]	5	Current NDC, Legacy NDC, 6 package rows	20240921_268c3f6b-8798-7987-3b8c-7b7f560af5d7.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/Timolol Maleate Ophthalmic Solution	BRIMONIDINE TARTRATE AND TIMOLOL MALEATE	Apotex Corp.	268c3f6b-8798-7987-3b8c-7b7f560af5d7	2026-04-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091442 application number: ANDA091442 ndc (product): 60505-0589

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
861635	brimonidine tartrate 0.2 % / timolol maleate 0.5 % Ophthalmic Solution	PSN	268c3f6b-8798-7987-3b8c-7b7f560af5d7	7
861635	brimonidine tartrate 2 MG/ML / timolol 5 MG/ML Ophthalmic Solution	SCD	268c3f6b-8798-7987-3b8c-7b7f560af5d7	7
861635	brimonidine tartrate 0.2 % / timolol 0.5 % (as timolol maleate 6.8 MG/ML) Ophthalmic Solution	SY	268c3f6b-8798-7987-3b8c-7b7f560af5d7	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
60505-0589-1	60505058901	1 BOTTLE, DROPPER in 1 CARTON (60505-0589-1) / 5 mL in 1 BOTTLE, DROPPER	2022-10-19	0000-00-00	No	No	Current
60505-0589-2	60505058902	1 BOTTLE, DROPPER in 1 CARTON (60505-0589-2) / 10 mL in 1 BOTTLE, DROPPER	2022-10-19	0000-00-00	No	No	Current
60505-0589-3	60505058903	1 BOTTLE, DROPPER in 1 CARTON (60505-0589-3) / 15 mL in 1 BOTTLE, DROPPER	2022-10-19	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution	Apotex Corp.	2026-04-23	HUMAN PRESCRIPTION DRUG LABEL	7
Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution	Bryant Ranch Prepack	2024-10-04	HUMAN PRESCRIPTION DRUG LABEL	102