TIMOLOL MALEATE

Product NDC: 55545-1001
11-digit product format: 555451001
Labeler code: 55545
Product ID: 55545-1001_5de7796b-8c4b-4e1a-96c2-3ee63a576a68
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: timolol maleate
Dosage form: SOLUTION/ DROPS
Route: OPHTHALMIC
Labeler: FDC Limited
Application: ANDA077259
Marketing category: ANDA
Marketing start: 2014-12-15
Marketing end: 0000-00-00
Substance: TIMOLOL MALEATE
Active strength: 5 mg/mL
Pharmacologic classes: Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]
NDC exclude flag: No
Listing certified through: 2020-12-31
Current FDA listing: Historical FDA.report record

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A077259-001	TIMOLOL MALEATE	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1		2008-04-30
A077259-002	TIMOLOL MALEATE	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1		2008-04-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A077259-001	AT1
A077259-002	AT1

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 3 · 82 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
2026-02-19 14:30 UTC	2026-02	A077259-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2008-04-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077259-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2008-04-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077259-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2008-04-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077259-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2008-04-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077259-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2008-04-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077259-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2008-04-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077259-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2008-04-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077259-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2008-04-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077259-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2008-04-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077259-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2008-04-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077259-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2008-04-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077259-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2008-04-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077259-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2008-04-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077259-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2008-04-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077259-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2008-04-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077259-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2008-04-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077259-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2008-04-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077259-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2008-04-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077259-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2008-04-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077259-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2008-04-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077259-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2008-04-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077259-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2008-04-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077259-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2008-04-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077259-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2008-04-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077259-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2008-04-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077259-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2008-04-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077259-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2008-04-30	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077259-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2008-04-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077259-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2008-04-30	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077259-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2008-04-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077259-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2008-04-30	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077259-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2008-04-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077259-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2008-04-30	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077259-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2008-04-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077259-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2008-04-30	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077259-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2008-04-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077259-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2008-04-30	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077259-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2008-04-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077259-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2008-04-30	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A077259-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2008-04-30	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A077259-001	AT1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077259-002	AT1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077259-001	AT1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077259-002	AT1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077259-001	AT1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077259-002	AT1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077259-001	AT1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077259-002	AT1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077259-001	AT1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077259-002	AT1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077259-001	AT1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077259-002	AT1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077259-001	AT1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077259-002	AT1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077259-001	AT1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077259-002	AT1	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077259-001	AT1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077259-002	AT1	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077259-001	AT1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077259-002	AT1	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077259-001	AT1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077259-002	AT1	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077259-001	AT1	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077259-002	AT1	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077259-001	AT1	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077259-002	AT1	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077259-001	AT1	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077259-002	AT1	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077259-001	AT1	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077259-002	AT1	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077259-001	AT1	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077259-002	AT1	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077259-001	AT1	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077259-002	AT1	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077259-001	AT	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077259-002	AT1	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077259-001	AT1	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077259-002	AT1	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077259-001	AT	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A077259-002	AT1	1	`782e0a99824c…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
c6c0c444-a6ba-2fb5-a7bc-7f0443fa5791	Product name	4	20251208
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
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
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
55545-1001-1	TIMOLOL MALEATE	1 in 1 CARTON	SOLUTION/ DROPS	1	3
55545-1001-1	TIMOLOL MALEATE	5 mL in 1 BOTTLE	SOLUTION/ DROPS	5	3
55545-1001-2	TIMOLOL MALEATE	10 mL in 1 BOTTLE	SOLUTION/ DROPS	10	3
55545-1001-2	TIMOLOL MALEATE	1 in 1 CARTON	SOLUTION/ DROPS	1	3
55545-1001-3	TIMOLOL MALEATE	15 mL in 1 BOTTLE	SOLUTION/ DROPS	15	3
55545-1001-3	TIMOLOL MALEATE	1 in 1 CARTON	SOLUTION/ DROPS	1	3

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
TIMOLOL MALEATE	ACTIVE INGREDIENT	P8Y54F701R	TIMOLOL MALEATE SOLUTION/ DROPS [FDC LIMITED]	2
TIMOLOL ANHYDROUS	ACTIVE MOIETY	5JKY92S7BR	TIMOLOL MALEATE SOLUTION/ DROPS [FDC LIMITED]	2
BENZALKONIUM CHLORIDE	INACTIVE INGREDIENT	F5UM2KM3W7	TIMOLOL MALEATE SOLUTION/ DROPS [FDC LIMITED]	2
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	TIMOLOL MALEATE SOLUTION/ DROPS [FDC LIMITED]	2
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	TIMOLOL MALEATE SOLUTION/ DROPS [FDC LIMITED]	2
SODIUM PHOSPHATE, DIBASIC, DODECAHYDRATE	INACTIVE INGREDIENT	E1W4N241FO	TIMOLOL MALEATE SOLUTION/ DROPS [FDC LIMITED]	2
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE	INACTIVE INGREDIENT	5QWK665956	TIMOLOL MALEATE SOLUTION/ DROPS [FDC LIMITED]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	TIMOLOL MALEATE SOLUTION/ DROPS [FDC LIMITED]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55545-1001	TIMOLOL MALEATE SOLUTION/ DROPS [FDC LIMITED]	3	Legacy NDC, 6 package rows	20171122_42887224-997c-4f08-8e2c-918de7195a6e.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
TIMOLOL MALEATE	TIMOLOL MALEATE	Rising Pharma Holdings, Inc.	2ed21930-1e05-46de-8acd-cb6f4798a7fa	2025-05-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077259 application number: ANDA077259

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
P8Y54F701R	TIMOLOL MALEATE	26921-17-5	TIMOLOL MALEATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1992303	timolol 0.5 % 12HR Ophthalmic Solution	PSN	42887224-997c-4f08-8e2c-918de7195a6e	3
1992303	12 HR timolol 5 MG/ML Ophthalmic Solution	SCD	42887224-997c-4f08-8e2c-918de7195a6e	3
1992303	timolol 0.5 % (as timolol maleate 6.8 MG/ML) 12 HR Ophthalmic Solution	SY	42887224-997c-4f08-8e2c-918de7195a6e	3
1992303	timolol 0.5 % 12 HR Ophthalmic Solution	SY	42887224-997c-4f08-8e2c-918de7195a6e	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
55545-1001-1	55545100101	1 in 1 CARTON		Historical
55545-1001-2	55545100102	10 mL in 1 BOTTLE	10 ml	Historical
55545-1001-3	55545100103	15 mL in 1 BOTTLE	15 ml	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
STERILE OPHTHALMIC SOLUTION TIMOLOL MALEATE OPHTHALMIC SOLUTION USP 0.25% AND 0.5%	FDC Limited	2017-11-21	HUMAN PRESCRIPTION DRUG LABEL	3