Brimonidine tartrate and Timolol maleate

Product NDC: 71921-188
11-digit product format: 719210188
Labeler code: 71921
Product ID: 71921-188_0b25c3d0-6cf7-cce0-e063-6294a90a8ea9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Brimonidine tartrate and Timolol maleate
Dosage form: SOLUTION
Route: OPHTHALMIC
Labeler: Florida Pharmaceutical Products, LLC
Application: ANDA201949
Marketing category: ANDA
Marketing start: 2023-11-23
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 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…`

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 ndc (product): 71921-188
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

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

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
7011a203-46cf-434d-ba11-253f107ff80f	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
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
71921-188-05	BRIMONIDINE TARTRATE AND TIMOLOL MALEATE	1 in 1 CARTON	SOLUTION	1	3
71921-188-05	BRIMONIDINE TARTRATE AND TIMOLOL MALEATE	5 mL in 1 BOTTLE, DROPPER	SOLUTION	5	3
71921-188-10	BRIMONIDINE TARTRATE AND TIMOLOL MALEATE	10 mL in 1 BOTTLE, DROPPER	SOLUTION	10	3
71921-188-10	BRIMONIDINE TARTRATE AND TIMOLOL MALEATE	1 in 1 CARTON	SOLUTION	1	3
71921-188-15	BRIMONIDINE TARTRATE AND TIMOLOL MALEATE	15 mL in 1 BOTTLE, DROPPER	SOLUTION	15	3
71921-188-15	BRIMONIDINE TARTRATE AND TIMOLOL MALEATE	1 in 1 CARTON	SOLUTION	1	3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71921-188-05	ML - Milliliter	71921-188	8ae11a70-8bdc-4683-890b-4f647e91254e	1	2023-12-05
71921-188-10	ML - Milliliter	71921-188	d380bddf-8ef9-4b6b-96c3-4906ca915054	1	2023-12-05
71921-188-15	ML - Milliliter	71921-188	5a21fb88-d473-4f87-bda7-347ba28f65ff	1	2023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71921-188	BRIMONIDINE TARTRATE AND TIMOLOL MALEATE (BRIMONIDINE TARTRATE AND TIMOLOL MALEATE) SOLUTION [FLORIDA PHARMACEUTICAL PRODUCTS, LLC]	1	Current NDC, 6 package rows	20231129_7011a203-46cf-434d-ba11-253f107ff80f.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	7011a203-46cf-434d-ba11-253f107ff80f	3
861635	brimonidine tartrate 2 MG/ML / timolol 5 MG/ML Ophthalmic Solution	SCD	7011a203-46cf-434d-ba11-253f107ff80f	3
861635	brimonidine tartrate 0.2 % / timolol 0.5 % (as timolol maleate 6.8 MG/ML) Ophthalmic Solution	SY	7011a203-46cf-434d-ba11-253f107ff80f	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
71921-188-05	71921018805	1 BOTTLE, DROPPER in 1 CARTON (71921-188-05) / 5 mL in 1 BOTTLE, DROPPER	2023-11-23	No	No	Current
71921-188-10	71921018810	1 BOTTLE, DROPPER in 1 CARTON (71921-188-10) / 10 mL in 1 BOTTLE, DROPPER	2023-11-23	No	No	Current
71921-188-15	71921018815	1 BOTTLE, DROPPER in 1 CARTON (71921-188-15) / 15 mL in 1 BOTTLE, DROPPER	2023-11-23	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
BRIMONIDINE TARTRATE AND TIMOLOL MALEATE	Florida Pharmaceutical Products, LLC \| INDOCO REMEDIES LIMITED	2026-05-27	Human Prescription Drug Label	3