Brimonidine Tartrate and Timolol Maleate

Product NDC: 0832-1425
11-digit product format: 008321425
Labeler code: 0832
Product ID: 0832-1425_26693226-0059-2890-e063-6394a90abf9a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Brimonidine Tartrate and Timolol Maleate
Dosage form: SOLUTION/ DROPS
Route: OPHTHALMIC
Labeler: Upsher-Smith Laboratories, LLC
Application: ANDA215598
Marketing category: ANDA
Marketing start: 2022-12-15
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: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A215598-001	BRIMONIDINE TARTRATE AND TIMOLOL MALEATE	BRIMONIDINE TARTRATE; TIMOLOL MALEATE	0.2%;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AB		2022-12-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A215598-001	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
2026-09-14 22:38:34	2026-08	A215598-001	BRIMONIDINE TARTRATE AND TIMOLOL MALEATE	0.2%;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AB	2022-12-12	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A215598-001	BRIMONIDINE TARTRATE AND TIMOLOL MALEATE	0.2%;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AB	2022-12-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A215598-001	BRIMONIDINE TARTRATE AND TIMOLOL MALEATE	0.2%;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AB	2022-12-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215598-001	BRIMONIDINE TARTRATE AND TIMOLOL MALEATE	0.2%;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AB	2022-12-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215598-001	BRIMONIDINE TARTRATE AND TIMOLOL MALEATE	0.2%;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AB	2022-12-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215598-001	BRIMONIDINE TARTRATE AND TIMOLOL MALEATE	0.2%;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AB	2022-12-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215598-001	BRIMONIDINE TARTRATE AND TIMOLOL MALEATE	0.2%;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AB	2022-12-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215598-001	BRIMONIDINE TARTRATE AND TIMOLOL MALEATE	0.2%;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AB	2022-12-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215598-001	BRIMONIDINE TARTRATE AND TIMOLOL MALEATE	0.2%;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AB	2022-12-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215598-001	BRIMONIDINE TARTRATE AND TIMOLOL MALEATE	0.2%;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AB	2022-12-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215598-001	BRIMONIDINE TARTRATE AND TIMOLOL MALEATE	0.2%;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AB	2022-12-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215598-001	BRIMONIDINE TARTRATE AND TIMOLOL MALEATE	0.2%;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AB	2022-12-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215598-001	BRIMONIDINE TARTRATE AND TIMOLOL MALEATE	0.2%;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AB	2022-12-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215598-001	BRIMONIDINE TARTRATE AND TIMOLOL MALEATE	0.2%;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AB	2022-12-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215598-001	BRIMONIDINE TARTRATE AND TIMOLOL MALEATE	0.2%;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AB	2022-12-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215598-001	BRIMONIDINE TARTRATE AND TIMOLOL MALEATE	0.2%;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AB	2022-12-12	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215598-001	BRIMONIDINE TARTRATE AND TIMOLOL MALEATE	0.2%;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AB	2022-12-12	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A215598-001	BRIMONIDINE TARTRATE AND TIMOLOL MALEATE	0.2%;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AB	2022-12-12	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A215598-001	BRIMONIDINE TARTRATE AND TIMOLOL MALEATE	0.2%;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AB	2022-12-12	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215598-001	BRIMONIDINE TARTRATE AND TIMOLOL MALEATE	0.2%;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AB	2022-12-12	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A215598-001	BRIMONIDINE TARTRATE AND TIMOLOL MALEATE	0.2%;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AB	2022-12-12	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A215598-001	BRIMONIDINE TARTRATE AND TIMOLOL MALEATE	0.2%;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AB	2022-12-12	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A215598-001	BRIMONIDINE TARTRATE AND TIMOLOL MALEATE	0.2%;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AB	2022-12-12	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A215598-001	BRIMONIDINE TARTRATE AND TIMOLOL MALEATE	0.2%;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AB	2022-12-12	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A215598-001	BRIMONIDINE TARTRATE AND TIMOLOL MALEATE	0.2%;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AB	2022-12-12	`3bdfa0b2c4d7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215598-001	BRIMONIDINE TARTRATE AND TIMOLOL MALEATE	0.2%;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AB	2022-12-12	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A215598-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A215598-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A215598-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215598-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215598-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215598-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215598-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215598-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215598-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215598-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215598-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215598-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215598-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215598-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215598-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215598-001	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215598-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A215598-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A215598-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215598-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A215598-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A215598-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A215598-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A215598-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A215598-001	AB	1	`3bdfa0b2c4d7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215598-001	AB	1	`a50c72e98297…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

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

Active Ingredients#

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

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
0832-1425-05	Brimonidine Tartrate and Timolol Maleate	5 mL in 1 BOTTLE, DROPPER	SOLUTION/ DROPS	5	5
0832-1425-05	Brimonidine Tartrate and Timolol Maleate	1 in 1 CARTON	SOLUTION/ DROPS	1	5
0832-1425-10	Brimonidine Tartrate and Timolol Maleate	10 mL in 1 BOTTLE, DROPPER	SOLUTION/ DROPS	10	5
0832-1425-10	Brimonidine Tartrate and Timolol Maleate	1 in 1 CARTON	SOLUTION/ DROPS	1	5
0832-1425-15	Brimonidine Tartrate and Timolol Maleate	15 mL in 1 BOTTLE, DROPPER	SOLUTION/ DROPS	15	5
0832-1425-15	Brimonidine Tartrate and Timolol Maleate	1 in 1 CARTON	SOLUTION/ DROPS	1	5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0832-1425-05	ML - Milliliter	0832-1425	dde9443e-e199-495b-abc5-848017314807	1	2023-03-13
0832-1425-10	ML - Milliliter	0832-1425	38f8d46a-e262-437a-90d4-275494f116af	1	2023-03-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0832-1425	BRIMONIDINE TARTRATE AND TIMOLOL MALEATE SOLUTION/ DROPS [UPSHER-SMITH LABORATORIES, LLC]	5	Current NDC, Legacy NDC, 6 package rows	20241109_b54e5bee-2329-4cc2-bed1-8eef11ee488c.zip

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	b54e5bee-2329-4cc2-bed1-8eef11ee488c	5
861635	brimonidine tartrate 2 MG/ML / timolol 5 MG/ML Ophthalmic Solution	SCD	b54e5bee-2329-4cc2-bed1-8eef11ee488c	5
861635	brimonidine tartrate 0.2 % / timolol 0.5 % (as timolol maleate 6.8 MG/ML) Ophthalmic Solution	SY	b54e5bee-2329-4cc2-bed1-8eef11ee488c	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0832-1425-05	00832142505	1 BOTTLE, DROPPER in 1 CARTON (0832-1425-05) / 5 mL in 1 BOTTLE, DROPPER	2023-01-09	0000-00-00	No	No	Current
0832-1425-10	00832142510	1 BOTTLE, DROPPER in 1 CARTON (0832-1425-10) / 10 mL in 1 BOTTLE, DROPPER	2023-01-09	0000-00-00	No	No	Current
0832-1425-15	00832142515	1 BOTTLE, DROPPER in 1 CARTON (0832-1425-15) / 15 mL in 1 BOTTLE, DROPPER	2023-10-20		No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Brimonidine Tartrate and Timolol Maleate	Upsher-Smith Laboratories, LLC \| Rafarm S.A,	2026-07-15	HUMAN PRESCRIPTION DRUG LABEL	7