Timolol Maleate

Product NDC: 24208-819
11-digit product format: 242080819
Labeler code: 24208
Product ID: 24208-819_b2a3e6e1-d01c-4d14-85ac-41905306d769
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Timolol Maleate
Dosage form: SOLUTION
Route: OPHTHALMIC
Labeler: Bausch & Lomb Incorporated
Application: NDA020330
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2018-02-14
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: 2022-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	24208-819		D	Discontinued by firm		2026-08-07
excluded package	package	24208-819	24208-819-05	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
N020330-001	TIMOPTIC-XE	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RLD	1993-11-04
N020330-002	TIMOPTIC-XE	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RLD	1993-11-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N020330-001	AB
N020330-002	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.

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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N020330-001	TIMOPTIC-XE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RLD	1993-11-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020330-002	TIMOPTIC-XE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RLD	1993-11-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020330-001	TIMOPTIC-XE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RLD	1993-11-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020330-002	TIMOPTIC-XE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RLD	1993-11-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020330-001	TIMOPTIC-XE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RLD	1993-11-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020330-002	TIMOPTIC-XE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RLD	1993-11-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020330-001	TIMOPTIC-XE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RLD	1993-11-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020330-002	TIMOPTIC-XE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RLD	1993-11-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020330-001	TIMOPTIC-XE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RLD	1993-11-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020330-002	TIMOPTIC-XE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RLD	1993-11-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020330-001	TIMOPTIC-XE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RLD	1993-11-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020330-002	TIMOPTIC-XE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RLD	1993-11-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020330-001	TIMOPTIC-XE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RLD	1993-11-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020330-002	TIMOPTIC-XE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RLD	1993-11-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020330-001	TIMOPTIC-XE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RLD	1993-11-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020330-002	TIMOPTIC-XE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RLD	1993-11-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020330-001	TIMOPTIC-XE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RLD	1993-11-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020330-002	TIMOPTIC-XE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RLD	1993-11-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020330-001	TIMOPTIC-XE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RLD	1993-11-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020330-002	TIMOPTIC-XE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RLD	1993-11-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020330-001	TIMOPTIC-XE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RLD	1993-11-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020330-002	TIMOPTIC-XE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RLD	1993-11-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020330-001	TIMOPTIC-XE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RLD	1993-11-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020330-002	TIMOPTIC-XE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RLD	1993-11-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020330-001	TIMOPTIC-XE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RLD	1993-11-04	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020330-002	TIMOPTIC-XE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RLD	1993-11-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020330-001	TIMOPTIC-XE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RLD	1993-11-04	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020330-002	TIMOPTIC-XE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RLD	1993-11-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020330-001	TIMOPTIC-XE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RLD	1993-11-04	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020330-002	TIMOPTIC-XE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RLD	1993-11-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020330-001	TIMOPTIC-XE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RLD	1993-11-04	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020330-002	TIMOPTIC-XE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RLD	1993-11-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020330-001	TIMOPTIC-XE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RLD	1993-11-04	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020330-002	TIMOPTIC-XE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RLD	1993-11-04	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020330-001	TIMOPTIC-XE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RLD, RS	1993-11-04	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020330-002	TIMOPTIC-XE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RLD, RS	1993-11-04	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020330-001	TIMOPTIC-XE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RLD	1993-11-04	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020330-002	TIMOPTIC-XE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RLD	1993-11-04	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020330-001	TIMOPTIC-XE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RLD	1993-11-04	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N020330-002	TIMOPTIC-XE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RLD	1993-11-04	`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	N020330-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020330-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020330-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020330-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020330-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020330-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020330-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020330-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020330-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020330-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020330-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020330-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020330-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020330-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020330-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020330-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020330-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020330-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020330-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020330-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020330-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020330-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020330-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020330-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020330-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020330-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020330-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020330-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020330-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020330-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020330-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020330-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020330-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020330-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020330-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020330-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020330-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020330-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020330-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N020330-002	AB	1	`782e0a99824c…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
24208-819-05	ML - Milliliter	24208-819	f8053fda-56e8-4de9-bc21-8bec07bae4d0	1	2018-03-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
24208-819	TIMOLOL MALEATE SOLUTION [BAUSCH & LOMB INCORPORATED]	2	Legacy NDC	20210605_1f886442-2781-4be4-b20d-d22c2c209790.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.	581f80f7-4419-49e2-867d-40443c75409f	2025-03-26	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020330 application number: NDA020330
Timoptic-XE	TIMOLOL MALEATE	Bausch & Lomb Incorporated	a4d03de7-06b7-4cfc-9d1b-616969df209c	2022-03-31	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020330 application number: NDA020330

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
24208-819-05	24208081905	1 BOTTLE, DISPENSING in 1 CARTON (24208-819-05) > 5 mL in 1 BOTTLE, DISPENSING	2018-02-14	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Timolol Maleate	Bausch & Lomb Incorporated \| Renaissance Lakewood LLC \| Carton Services, Incorporated	2021-02-22	HUMAN PRESCRIPTION DRUG LABEL	2