Timolol Maleate

Product NDC: 42571-404
11-digit product format: 425710404
Labeler code: 42571
Product ID: 42571-404_238fd036-1868-da83-e063-6394a90a0596
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Timolol Maleate Ophthalmic
Dosage form: SOLUTION/ DROPS
Route: OPHTHALMIC
Labeler: Micro Labs Limited
Application: ANDA217343
Marketing category: ANDA
Marketing start: 2023-08-01
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: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A217343-001	TIMOLOL MALEATE	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1		2023-05-26
A217343-002	TIMOLOL MALEATE	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1		2023-05-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A217343-001	AT1
A217343-002	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 2 · 46 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
2026-08-18 06:07:40	2026-07	A217343-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2023-05-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A217343-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2023-05-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A217343-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2023-05-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217343-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2023-05-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217343-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2023-05-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217343-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2023-05-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217343-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2023-05-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217343-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2023-05-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217343-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2023-05-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217343-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2023-05-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217343-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2023-05-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217343-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2023-05-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217343-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2023-05-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217343-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2023-05-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217343-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2023-05-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217343-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2023-05-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217343-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2023-05-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217343-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2023-05-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217343-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2023-05-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217343-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2023-05-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A217343-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2023-05-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A217343-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2023-05-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217343-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2023-05-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217343-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2023-05-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217343-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2023-05-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217343-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2023-05-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217343-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2023-05-26	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217343-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2023-05-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A217343-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2023-05-26	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A217343-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2023-05-26	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A217343-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2023-05-26	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A217343-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2023-05-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A217343-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2023-05-26	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A217343-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2023-05-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A217343-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2023-05-26	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A217343-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2023-05-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A217343-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2023-05-26	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A217343-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2023-05-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A217343-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2023-05-26	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A217343-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2023-05-26	`9b2671bbb829…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 46 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A217343-001	AT1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A217343-002	AT1	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A217343-001	AT1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217343-002	AT1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217343-001	AT1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217343-002	AT1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217343-001	AT1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217343-002	AT1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217343-001	AT1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217343-002	AT1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217343-001	AT1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217343-002	AT1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217343-001	AT1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217343-002	AT1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217343-001	AT1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217343-002	AT1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217343-001	AT1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217343-002	AT1	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217343-001	AT1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217343-002	AT1	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A217343-001	AT1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A217343-002	AT1	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217343-001	AT1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217343-002	AT1	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217343-001	AT1	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217343-002	AT1	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217343-001	AT1	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217343-002	AT1	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A217343-001	AT1	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A217343-002	AT1	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A217343-001	AT1	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A217343-002	AT1	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A217343-001	AT1	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A217343-002	AT1	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A217343-001	AT1	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A217343-002	AT1	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A217343-001	AT1	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A217343-002	AT1	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A217343-001	AT1	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A217343-002	AT1	1	`9b2671bbb829…`

Additional Listing Data#

Finished product: Yes
Brand name base: Timolol Maleate
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TIMOLOL MALEATE	5 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1923428	Internal RxNorm lookup
1992303	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
6c9f3971-8c07-4d3a-915d-76438baa2a0b	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
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	Strength	SPL version
42571-404-21	Timolol Maleate	5 mL in 1 BOTTLE	SOLUTION/ DROPS	5		4
42571-404-88	Timolol Maleate	10 mL in 1 BOTTLE	SOLUTION/ DROPS	10		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42571-404-21	ML - Milliliter	42571-404	873aeb92-1934-4e5e-9783-507e527eaa92	1	2025-02-10
42571-404-88	ML - Milliliter	42571-404	6be9ffc9-56ca-4654-96d6-7450a9429921	1	2025-02-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42571-404	TIMOLOL MALEATE (TIMOLOL MALEATE OPHTHALMIC) SOLUTION/ DROPS [MICRO LABS LIMITED]	4	Current NDC, 2 package rows	20241004_6c9f3971-8c07-4d3a-915d-76438baa2a0b.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 OPHTHALMIC	Micro Labs Limited	6c9f3971-8c07-4d3a-915d-76438baa2a0b	2024-10-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217343 application number: ANDA217343 ndc (product): 42571-404

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	6c9f3971-8c07-4d3a-915d-76438baa2a0b	4
1923428	timolol maleate 0.25 % Ophthalmic Solution	PSN	6c9f3971-8c07-4d3a-915d-76438baa2a0b	4
1992303	12 HR timolol 5 MG/ML Ophthalmic Solution	SCD	6c9f3971-8c07-4d3a-915d-76438baa2a0b	4
1923428	timolol 2.5 MG/ML Ophthalmic Solution	SCD	6c9f3971-8c07-4d3a-915d-76438baa2a0b	4
1923428	timolol 0.25 % Ophthalmic Solution	SY	6c9f3971-8c07-4d3a-915d-76438baa2a0b	4
1992303	timolol 0.5 % (as timolol maleate 6.8 MG/ML) 12 HR Ophthalmic Solution	SY	6c9f3971-8c07-4d3a-915d-76438baa2a0b	4
1992303	timolol 0.5 % 12 HR Ophthalmic Solution	SY	6c9f3971-8c07-4d3a-915d-76438baa2a0b	4
1923428	timolol 2.5 MG/ML (as timolol maleate 3.4 MG/ML) Ophthalmic Solution	SY	6c9f3971-8c07-4d3a-915d-76438baa2a0b	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
42571-404-21	42571040421	5 mL in 1 BOTTLE (42571-404-21)	5 ml	2023-08-01	No	No	Current
42571-404-88	42571040488	10 mL in 1 BOTTLE (42571-404-88)	10 ml	2023-08-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Timolol Maleate Ophthalmic Solution, USP 0.25% and 0.5% Rx Only	Micro Labs Limited	2024-10-03	HUMAN PRESCRIPTION DRUG LABEL	4