Timolol Maleate

Product NDC: 68682-813
11-digit product format: 686820813
Labeler code: 68682
Product ID: 68682-813_64bbf424-1af1-428a-a819-633739e8e3fc
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Timolol Maleate
Dosage form: SOLUTION
Route: OPHTHALMIC
Labeler: Oceanside Pharmaceuticals
Application: NDA018086
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2020-06-01
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: 2023-12-31
Current FDA listing: Historical FDA.report record

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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	68682-813		D	Discontinued by firm	2026-08-07
excluded package	package	68682-813	68682-813-05	D	Discontinued by firm	2026-08-07
excluded package	package	68682-813	68682-813-10	D	Discontinued by firm	2026-08-07

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
N018086-001	TIMOPTIC	TIMOLOL MALEATE	EQ 0.25% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, Approved before 1982
N018086-002	TIMOPTIC	TIMOLOL MALEATE	EQ 0.5% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N018086-001	AT1
N018086-002	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	RLD / RS	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N018086-001	TIMOPTIC	EQ 0.25% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018086-002	TIMOPTIC	EQ 0.5% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018086-001	TIMOPTIC	EQ 0.25% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018086-002	TIMOPTIC	EQ 0.5% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018086-001	TIMOPTIC	EQ 0.25% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018086-002	TIMOPTIC	EQ 0.5% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018086-001	TIMOPTIC	EQ 0.25% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018086-002	TIMOPTIC	EQ 0.5% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018086-001	TIMOPTIC	EQ 0.25% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018086-002	TIMOPTIC	EQ 0.5% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018086-001	TIMOPTIC	EQ 0.25% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018086-002	TIMOPTIC	EQ 0.5% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018086-001	TIMOPTIC	EQ 0.25% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018086-002	TIMOPTIC	EQ 0.5% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018086-001	TIMOPTIC	EQ 0.25% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018086-002	TIMOPTIC	EQ 0.5% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018086-001	TIMOPTIC	EQ 0.25% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018086-002	TIMOPTIC	EQ 0.5% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018086-001	TIMOPTIC	EQ 0.25% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N018086-002	TIMOPTIC	EQ 0.5% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018086-001	TIMOPTIC	EQ 0.25% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018086-002	TIMOPTIC	EQ 0.5% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018086-001	TIMOPTIC	EQ 0.25% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018086-002	TIMOPTIC	EQ 0.5% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018086-001	TIMOPTIC	EQ 0.25% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, Approved before 1982	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018086-002	TIMOPTIC	EQ 0.5% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018086-001	TIMOPTIC	EQ 0.25% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, Approved before 1982	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N018086-002	TIMOPTIC	EQ 0.5% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018086-001	TIMOPTIC	EQ 0.25% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, Approved before 1982	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018086-002	TIMOPTIC	EQ 0.5% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018086-001	TIMOPTIC	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, Approved before 1982	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N018086-002	TIMOPTIC	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018086-001	TIMOPTIC	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, Approved before 1982	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N018086-002	TIMOPTIC	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018086-001	TIMOPTIC	EQ 0.25% BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N018086-002	TIMOPTIC	EQ 0.5% BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018086-001	TIMOPTIC	EQ 0.25% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, Approved before 1982	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N018086-002	TIMOPTIC	EQ 0.5% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N018086-001	TIMOPTIC	EQ 0.25% BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, Approved before 1982	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N018086-002	TIMOPTIC	EQ 0.5% BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, Approved before 1982	`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	N018086-001	AT1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018086-002	AT1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018086-001	AT1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018086-002	AT1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018086-001	AT1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018086-002	AT1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018086-001	AT1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018086-002	AT1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018086-001	AT1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018086-002	AT1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018086-001	AT1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018086-002	AT1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018086-001	AT1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018086-002	AT1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018086-001	AT1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018086-002	AT1	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018086-001	AT1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018086-002	AT1	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018086-001	AT1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N018086-002	AT1	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018086-001	AT1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018086-002	AT1	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018086-001	AT1	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018086-002	AT1	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018086-001	AT1	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018086-002	AT1	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018086-001	AT1	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N018086-002	AT1	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018086-001	AT1	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018086-002	AT1	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018086-001	AT1	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N018086-002	AT1	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018086-001	AT1	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N018086-002	AT1	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018086-001	AT	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N018086-002	AT1	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018086-001	AT1	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N018086-002	AT1	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N018086-001	AT	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N018086-002	AT1	1	`782e0a99824c…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68682-813-05	ML - Milliliter	68682-813	e015717b-73b4-4cb2-a437-1d9f6cb81593	1	2020-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68682-813	TIMOLOL MALEATE SOLUTION [OCEANSIDE PHARMACEUTICALS]	4	Legacy NDC	20220922_3ec1cc3c-1de1-4df3-8443-7b5a8cb21f85.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Timolol Maleate	TIMOLOL MALEATE	Bausch & Lomb Americas Inc.	9c14ca2d-80f3-48ef-b99a-beafaa728a24	2025-03-04	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018086 application number: NDA018086
Timoptic	TIMOLOL MALEATE	Bausch & Lomb Incorporated	45ac65b3-19f7-4f33-aebf-cadd3daa4bf1	2022-04-30	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018086 application number: NDA018086

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
68682-813-05	68682081305	1 BOTTLE, DISPENSING in 1 CARTON (68682-813-05) > 5 mL in 1 BOTTLE, DISPENSING	2020-06-01	0000-00-00	No	No	Current
68682-813-10	68682081310	1 BOTTLE, DISPENSING in 1 CARTON (68682-813-10) > 10 mL in 1 BOTTLE, DISPENSING	2020-06-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Timolol Maleate Ophthalmic Solution 0.25% and 0.5%	Oceanside Pharmaceuticals \| Bausch & Lomb Incorporated	2019-01-01	HUMAN PRESCRIPTION DRUG LABEL	4