Timoptic in Ocudose

Product NDC: 0187-1496
Requested package NDC: 0187-1496-05
11-digit product format: 001871496
Labeler code: 0187
Product ID: 0187-1496_c8e75822-985a-47a4-a5b2-baee3c6a7e22
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Timolol Maleate
Dosage form: SOLUTION
Route: OPHTHALMIC
Labeler: Bausch Health US LLC
Application: NDA019463
Marketing category: NDA
Marketing start: 1986-11-05
Marketing end: 0000-00-00
Substance: TIMOLOL MALEATE
Active strength: 7 mg/mL
Pharmacologic classes: Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]
NDC exclude flag: No
Listing certified through: 2021-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	0187-1496	0187-1496-05	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
N019463-001	TIMOPTIC IN OCUDOSE	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	RLD, RS	1986-11-05
N019463-002	TIMOPTIC IN OCUDOSE	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	RLD, RS	1986-11-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N019463-001	AT3
N019463-002	AT3

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	N019463-001	TIMOPTIC IN OCUDOSE	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	RLD, RS	1986-11-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019463-002	TIMOPTIC IN OCUDOSE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	RLD, RS	1986-11-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019463-001	TIMOPTIC IN OCUDOSE	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	RLD, RS	1986-11-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019463-002	TIMOPTIC IN OCUDOSE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	RLD, RS	1986-11-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019463-001	TIMOPTIC IN OCUDOSE	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	RLD, RS	1986-11-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019463-002	TIMOPTIC IN OCUDOSE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	RLD, RS	1986-11-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019463-001	TIMOPTIC IN OCUDOSE	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	RLD, RS	1986-11-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019463-002	TIMOPTIC IN OCUDOSE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	RLD, RS	1986-11-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019463-001	TIMOPTIC IN OCUDOSE	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	RLD, RS	1986-11-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019463-002	TIMOPTIC IN OCUDOSE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	RLD, RS	1986-11-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019463-001	TIMOPTIC IN OCUDOSE	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	RLD, RS	1986-11-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019463-002	TIMOPTIC IN OCUDOSE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	RLD, RS	1986-11-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019463-001	TIMOPTIC IN OCUDOSE	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	RLD, RS	1986-11-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019463-002	TIMOPTIC IN OCUDOSE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	RLD, RS	1986-11-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019463-001	TIMOPTIC IN OCUDOSE	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	RLD, RS	1986-11-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019463-002	TIMOPTIC IN OCUDOSE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	RLD, RS	1986-11-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019463-001	TIMOPTIC IN OCUDOSE	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	RLD, RS	1986-11-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019463-002	TIMOPTIC IN OCUDOSE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	RLD, RS	1986-11-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019463-001	TIMOPTIC IN OCUDOSE	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	RLD, RS	1986-11-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019463-002	TIMOPTIC IN OCUDOSE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	RLD, RS	1986-11-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019463-001	TIMOPTIC IN OCUDOSE	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	RLD, RS	1986-11-05	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019463-002	TIMOPTIC IN OCUDOSE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	RLD, RS	1986-11-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019463-001	TIMOPTIC IN OCUDOSE	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	RLD, RS	1986-11-05	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019463-002	TIMOPTIC IN OCUDOSE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	RLD, RS	1986-11-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019463-001	TIMOPTIC IN OCUDOSE	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	RLD, RS	1986-11-05	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019463-002	TIMOPTIC IN OCUDOSE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	RLD, RS	1986-11-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019463-001	TIMOPTIC IN OCUDOSE	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	RLD, RS	1986-11-05	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N019463-002	TIMOPTIC IN OCUDOSE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	RLD, RS	1986-11-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019463-001	TIMOPTIC IN OCUDOSE	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	RLD, RS	1986-11-05	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019463-002	TIMOPTIC IN OCUDOSE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	RLD, RS	1986-11-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019463-001	TIMOPTIC IN OCUDOSE	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	RLD, RS	1986-11-05	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N019463-002	TIMOPTIC IN OCUDOSE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	RLD, RS	1986-11-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019463-001	TIMOPTIC IN OCUDOSE	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	RLD, RS	1986-11-05	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N019463-002	TIMOPTIC IN OCUDOSE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	RLD, RS	1986-11-05	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N019463-001	TIMOPTIC IN OCUDOSE	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1986-11-05	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019463-002	TIMOPTIC IN OCUDOSE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1986-11-05	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N019463-001	TIMOPTIC IN OCUDOSE	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	RLD, RS	1986-11-05	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N019463-002	TIMOPTIC IN OCUDOSE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	RLD, RS	1986-11-05	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N019463-001	TIMOPTIC IN OCUDOSE	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1986-11-05	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N019463-002	TIMOPTIC IN OCUDOSE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	RLD, RS	1986-11-05	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 69 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	N019463-001	AT3	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019463-002	AT3	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019463-001	AT3	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019463-002	AT3	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019463-001	AT3	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019463-002	AT3	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019463-001	AT3	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019463-002	AT3	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019463-001	AT3	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019463-002	AT3	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019463-001	AT3	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019463-002	AT3	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019463-001	AT3	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019463-002	AT3	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019463-001	AT3	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019463-002	AT3	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019463-001	AT3	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019463-002	AT3	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019463-001	AT3	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019463-002	AT3	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019463-001	AT3	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019463-002	AT3	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019463-001	AT3	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019463-002	AT3	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019463-001	AT3	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019463-002	AT3	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019463-001	AT3	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N019463-002	AT3	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019463-001	AT3	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019463-002	AT3	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019463-001	AT3	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N019463-002	AT3	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019463-001	AT3	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N019463-002	AT3	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N019463-001	AT3	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N019463-002	AT3	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N019463-002	AT3	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019463-002	AT3	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N019463-002	AT3	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N019463-002	AT3	1	`8869cabd3fbd…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0187-1496-05	EA - Each	0187-1496	735d50fa-1870-4dcc-b485-721a1ca6e19b	1	2015-09-10

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Timolol Maleate	ACTIVE INGREDIENT	P8Y54F701R	TIMOPTIC (TIMOLOL MALEATE) SOLUTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	1
TIMOLOL ANHYDROUS	ACTIVE MOIETY	5JKY92S7BR	TIMOPTIC (TIMOLOL MALEATE) SOLUTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	1
Sodium Hydroxide	INACTIVE INGREDIENT	55X04QC32I	TIMOPTIC (TIMOLOL MALEATE) SOLUTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	1
Sodium Phosphate, Dibasic	INACTIVE INGREDIENT	GR686LBA74	TIMOPTIC (TIMOLOL MALEATE) SOLUTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	1
Sodium Phosphate, Monobasic	INACTIVE INGREDIENT	3980JIH2SW	TIMOPTIC (TIMOLOL MALEATE) SOLUTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	1
Water	INACTIVE INGREDIENT	059QF0KO0R	TIMOPTIC (TIMOLOL MALEATE) SOLUTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0187-1496	TIMOPTIC IN OCUDOSE (TIMOLOL MALEATE) SOLUTION [BAUSCH HEALTH US LLC]	11	Legacy NDC	20200415_c1293d51-b633-486c-8e13-fcf60063faeb.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.	036dc753-1698-4c69-9bcf-752c7061203c	2025-03-05	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019463 application number: NDA019463
Timoptic in Ocudose	TIMOLOL MALEATE	Bausch & Lomb Incorporated	d130f0ec-c3b5-4bc3-8f4a-68fd6c3ec0cf	2022-01-31	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019463 application number: NDA019463

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	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0187-1496-05	00187149605	4 POUCH in 1 CARTON (0187-1496-05) > 15 CONTAINER in 1 POUCH > .3 mL in 1 CONTAINER	4 pouch	1986-11-05	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
TIMOPTIC ® in OCUDOSE ® 0.25% and 0.5% (timolol maleate ophthalmic solution)	Bausch Health US LLC \| Laboratoire Unither	2020-01-06	HUMAN PRESCRIPTION DRUG LABEL	11