Timolol Maleate

Product NDC: 68682-045
Requested package NDC: 68682-045-25
11-digit product format: 686820045
Labeler code: 68682
Product ID: 68682-045_4fe86cd0-e1e4-e99c-e063-6294a90a2f03
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Timolol Maleate
Dosage form: SOLUTION/ DROPS
Route: OPHTHALMIC
Labeler: Oceanside Pharmaceuticals
Application: NDA021516
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2018-05-30
Marketing end: 2026-08-31
Substance: TIMOLOL MALEATE
Active strength: 5 mg/mL
Pharmacologic classes: Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]
NDC exclude flag: No
Current FDA listing: Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	68682-045	68682-045-25	D	Discontinued by firm		2026-09-09

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

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
N021516-001	ISTALOL	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT2	RLD, RS	2004-06-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N021516-001	AT2

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 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N021516-001	ISTALOL	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT2	RLD, RS	2004-06-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021516-001	ISTALOL	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT2	RLD, RS	2004-06-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021516-001	ISTALOL	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT2	RLD, RS	2004-06-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021516-001	ISTALOL	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT2	RLD, RS	2004-06-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021516-001	ISTALOL	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT2	RLD, RS	2004-06-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021516-001	ISTALOL	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT2	RLD, RS	2004-06-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021516-001	ISTALOL	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT2	RLD, RS	2004-06-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021516-001	ISTALOL	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT2	RLD, RS	2004-06-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021516-001	ISTALOL	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT2	RLD, RS	2004-06-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021516-001	ISTALOL	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT2	RLD, RS	2004-06-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021516-001	ISTALOL	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT2	RLD, RS	2004-06-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021516-001	ISTALOL	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT2	RLD, RS	2004-06-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021516-001	ISTALOL	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT2	RLD, RS	2004-06-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021516-001	ISTALOL	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT2	RLD, RS	2004-06-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021516-001	ISTALOL	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT2	RLD, RS	2004-06-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021516-001	ISTALOL	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT2	RLD, RS	2004-06-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021516-001	ISTALOL	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT2	RLD, RS	2004-06-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021516-001	ISTALOL	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT2	RLD, RS	2004-06-04	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021516-001	ISTALOL	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT2	RLD, RS	2004-06-04	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021516-001	ISTALOL	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT2	RLD, RS	2004-06-04	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021516-001	ISTALOL	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT2	RLD, RS	2004-06-04	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021516-001	ISTALOL	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT2	RLD, RS	2004-06-04	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021516-001	ISTALOL	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT2	RLD, RS	2004-06-04	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021516-001	ISTALOL	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT2	RLD, RS	2004-06-04	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021516-001	ISTALOL	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT2	RLD, RS	2004-06-04	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021516-001	ISTALOL	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT2	RLD, RS	2004-06-04	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021516-001	ISTALOL	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT2	RLD, RS	2004-06-04	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021516-001	ISTALOL	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT2	RLD, RS	2004-06-04	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021516-001	ISTALOL	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT2	RLD, RS	2004-06-04	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021516-001	ISTALOL	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT2	RLD, RS	2004-06-04	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021516-001	ISTALOL	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT2	RLD, RS	2004-06-04	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021516-001	ISTALOL	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT2	RLD, RS	2004-06-04	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021516-001	ISTALOL	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT2	RLD, RS	2004-06-04	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021516-001	ISTALOL	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT2	RLD, RS	2004-06-04	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021516-001	ISTALOL	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT2	RLD, RS	2004-06-04	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021516-001	ISTALOL	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT2	RLD, RS	2004-06-04	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021516-001	ISTALOL	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT2	RLD, RS	2004-06-04	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021516-001	ISTALOL	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT2	RLD, RS	2004-06-04	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021516-001	ISTALOL	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT2	RLD, RS	2004-06-04	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021516-001	ISTALOL	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT2	RLD, RS	2004-06-04	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 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	N021516-001	AT2	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021516-001	AT2	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021516-001	AT2	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021516-001	AT2	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021516-001	AT2	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021516-001	AT2	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021516-001	AT2	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021516-001	AT2	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021516-001	AT2	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021516-001	AT2	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021516-001	AT2	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021516-001	AT2	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021516-001	AT2	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021516-001	AT2	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021516-001	AT2	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021516-001	AT2	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021516-001	AT2	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021516-001	AT2	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021516-001	AT2	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021516-001	AT2	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021516-001	AT2	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021516-001	AT2	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021516-001	AT2	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021516-001	AT2	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021516-001	AT2	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021516-001	AT2	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021516-001	AT2	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021516-001	AT2	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021516-001	AT2	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021516-001	AT2	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021516-001	AT2	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021516-001	AT2	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021516-001	AT2	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021516-001	AT2	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021516-001	AT2	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021516-001	AT2	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021516-001	AT2	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021516-001	AT2	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021516-001	AT2	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021516-001	AT2	1	`e64feba35796…`

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
726062af-1135-4707-a1d7-57256991bbf9	Product name	2	20250226
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
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
68682-045-25	Timolol Maleate	2.5 mL in 1 BOTTLE, DROPPER	SOLUTION/ DROPS	2.5	3
68682-045-25	Timolol Maleate	1 in 1 CARTON	SOLUTION/ DROPS	1	3
68682-045-50	Timolol Maleate	1 in 1 CARTON	SOLUTION/ DROPS	1	3
68682-045-50	Timolol Maleate	5 mL in 1 BOTTLE, DROPPER	SOLUTION/ DROPS	5	3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68682-045-25	ML - Milliliter	68682-045	c4a3eabc-ca78-44af-adba-ffbf7bebf921	1	2018-07-03
68682-045-50	ML - Milliliter	68682-045	7c0dc24a-0aee-40a0-9f3d-2d580fef4686	1	2018-07-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68682-045	TIMOLOL MALEATE SOLUTION/ DROPS [OCEANSIDE PHARMACEUTICALS]	2	Current NDC, Legacy NDC, 4 package rows	20200124_3c20b537-88c6-4ec7-a359-e0ba67afe431.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Timolol Maleate	TIMOLOL MALEATE	Oceanside Pharmaceuticals	3c20b537-88c6-4ec7-a359-e0ba67afe431	2026-04-20	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021516 application number: NDA021516 ndc (package): 68682-045-25 ndc (product): 68682-045 ndc11 (package): 68682004525
Timolol Maleate	TIMOLOL MALEATE	Bausch & Lomb Americas Inc.	b686bbad-1ef7-4b94-a316-4d182a40b89a	2024-11-04	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021516 application number: NDA021516
Istalol	TIMOLOL MALEATE	Bausch & Lomb Incorporated	258bbc8d-00ee-45b0-ac35-6f16c4e8d45f	2024-10-30	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021516 application number: NDA021516

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
1992299	timolol 0.5 % 24HR Ophthalmic Solution	PSN	3c20b537-88c6-4ec7-a359-e0ba67afe431	3
1992299	24 HR timolol 5 MG/ML Ophthalmic Solution	SCD	3c20b537-88c6-4ec7-a359-e0ba67afe431	3
1992299	timolol 0.5 % (as timolol maleate 6.8 MG/ML) 24 HR Ophthalmic Solution	SY	3c20b537-88c6-4ec7-a359-e0ba67afe431	3
1992299	timolol 0.5 % 24 HR Ophthalmic Solution	SY	3c20b537-88c6-4ec7-a359-e0ba67afe431	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
68682-045-25	68682004525	1 BOTTLE, DROPPER in 1 CARTON (68682-045-25) / 2.5 mL in 1 BOTTLE, DROPPER	2018-05-30	2026-08-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Timolol Maleate	Oceanside Pharmaceuticals \| Bausch & Lomb Incorporated	2026-04-20	HUMAN PRESCRIPTION DRUG LABEL	3