Timolol Maleate

Product NDC: 0378-0055
11-digit product format: 003780055
Labeler code: 0378
Product ID: 0378-0055_96dd25ab-c0a7-47e6-b056-c53813615d36
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: timolol maleate
Dosage form: TABLET
Route: ORAL
Labeler: Mylan Pharmaceuticals Inc.
Application: ANDA072668
Marketing category: ANDA
Marketing start: 1990-06-08
Marketing end: 0000-00-00
Substance: TIMOLOL MALEATE
Active strength: 5 mg/1
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	0378-0055		D	Discontinued by firm		2026-08-17
excluded package	package	0378-0055	0378-0055-01	D	Discontinued by firm		2026-08-17

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A072668-001	TIMOLOL MALEATE	TIMOLOL MALEATE	20MG	TABLET / ORAL		1990-06-08
A072668-002	TIMOLOL MALEATE	TIMOLOL MALEATE	5MG	TABLET / ORAL		1990-06-08
A072668-003	TIMOLOL MALEATE	TIMOLOL MALEATE	10MG	TABLET / ORAL	AB	1990-06-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A072668-003	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 4 · 126 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	A072668-001	TIMOLOL MALEATE	20MG	TABLET / ORAL			1990-06-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A072668-002	TIMOLOL MALEATE	5MG	TABLET / ORAL			1990-06-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A072668-003	TIMOLOL MALEATE	10MG	TABLET / ORAL	AB		1990-06-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A072668-001	TIMOLOL MALEATE	20MG	TABLET / ORAL	AB	RS	1990-06-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A072668-002	TIMOLOL MALEATE	5MG	TABLET / ORAL	AB		1990-06-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A072668-003	TIMOLOL MALEATE	10MG	TABLET / ORAL	AB		1990-06-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A072668-001	TIMOLOL MALEATE	20MG	TABLET / ORAL	AB	RS	1990-06-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A072668-002	TIMOLOL MALEATE	5MG	TABLET / ORAL	AB		1990-06-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A072668-003	TIMOLOL MALEATE	10MG	TABLET / ORAL	AB		1990-06-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A072668-001	TIMOLOL MALEATE	20MG	TABLET / ORAL	AB	RS	1990-06-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A072668-002	TIMOLOL MALEATE	5MG	TABLET / ORAL	AB		1990-06-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A072668-003	TIMOLOL MALEATE	10MG	TABLET / ORAL	AB		1990-06-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A072668-001	TIMOLOL MALEATE	20MG	TABLET / ORAL	AB	RS	1990-06-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A072668-002	TIMOLOL MALEATE	5MG	TABLET / ORAL	AB		1990-06-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A072668-003	TIMOLOL MALEATE	10MG	TABLET / ORAL	AB		1990-06-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A072668-001	TIMOLOL MALEATE	20MG	TABLET / ORAL	AB	RS	1990-06-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A072668-002	TIMOLOL MALEATE	5MG	TABLET / ORAL	AB		1990-06-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A072668-003	TIMOLOL MALEATE	10MG	TABLET / ORAL	AB		1990-06-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A072668-001	TIMOLOL MALEATE	20MG	TABLET / ORAL	AB	RS	1990-06-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A072668-002	TIMOLOL MALEATE	5MG	TABLET / ORAL	AB		1990-06-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A072668-003	TIMOLOL MALEATE	10MG	TABLET / ORAL	AB		1990-06-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A072668-001	TIMOLOL MALEATE	20MG	TABLET / ORAL	AB	RS	1990-06-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A072668-002	TIMOLOL MALEATE	5MG	TABLET / ORAL	AB		1990-06-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A072668-003	TIMOLOL MALEATE	10MG	TABLET / ORAL	AB		1990-06-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A072668-001	TIMOLOL MALEATE	20MG	TABLET / ORAL	AB	RS	1990-06-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A072668-002	TIMOLOL MALEATE	5MG	TABLET / ORAL	AB		1990-06-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A072668-003	TIMOLOL MALEATE	10MG	TABLET / ORAL	AB		1990-06-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A072668-001	TIMOLOL MALEATE	20MG	TABLET / ORAL	AB	RS	1990-06-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A072668-002	TIMOLOL MALEATE	5MG	TABLET / ORAL	AB		1990-06-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A072668-003	TIMOLOL MALEATE	10MG	TABLET / ORAL	AB		1990-06-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A072668-001	TIMOLOL MALEATE	20MG	TABLET / ORAL	AB	RS	1990-06-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A072668-002	TIMOLOL MALEATE	5MG	TABLET / ORAL	AB		1990-06-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A072668-003	TIMOLOL MALEATE	10MG	TABLET / ORAL	AB		1990-06-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A072668-001	TIMOLOL MALEATE	20MG	TABLET / ORAL	AB	RS	1990-06-08	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A072668-002	TIMOLOL MALEATE	5MG	TABLET / ORAL	AB		1990-06-08	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A072668-003	TIMOLOL MALEATE	10MG	TABLET / ORAL	AB		1990-06-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A072668-001	TIMOLOL MALEATE	20MG	TABLET / ORAL	AB	RS	1990-06-08	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A072668-002	TIMOLOL MALEATE	5MG	TABLET / ORAL	AB		1990-06-08	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A072668-003	TIMOLOL MALEATE	10MG	TABLET / ORAL	AB		1990-06-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A072668-001	TIMOLOL MALEATE	20MG	TABLET / ORAL	AB	RS	1990-06-08	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 122 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	A072668-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A072668-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A072668-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A072668-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A072668-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A072668-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A072668-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A072668-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A072668-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A072668-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A072668-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A072668-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A072668-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A072668-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A072668-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A072668-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A072668-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A072668-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A072668-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A072668-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A072668-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A072668-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A072668-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A072668-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A072668-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A072668-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A072668-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A072668-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A072668-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A072668-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A072668-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A072668-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A072668-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A072668-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A072668-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A072668-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A072668-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A072668-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A072668-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A072668-003	AB	1	`1e350fbaab3a…`

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
0378-0055-01	Timolol Maleate	100 in 1 BOTTLE, PLASTIC	TABLET	100		10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0378-0055-01	EA - Each	0378-0055	e2d4984b-0909-4c19-8efb-694bed74f129	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
TIMOLOL MALEATE	ACTIVE INGREDIENT	P8Y54F701R	TIMOLOL MALEATE TABLET [MYLAN PHARMACEUTICALS INC.]	5
TIMOLOL ANHYDROUS	ACTIVE MOIETY	5JKY92S7BR	TIMOLOL MALEATE TABLET [MYLAN PHARMACEUTICALS INC.]	5
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	TIMOLOL MALEATE TABLET [MYLAN PHARMACEUTICALS INC.]	5
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	TIMOLOL MALEATE TABLET [MYLAN PHARMACEUTICALS INC.]	5
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	TIMOLOL MALEATE TABLET [MYLAN PHARMACEUTICALS INC.]	5
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	TIMOLOL MALEATE TABLET [MYLAN PHARMACEUTICALS INC.]	5
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	TIMOLOL MALEATE TABLET [MYLAN PHARMACEUTICALS INC.]	5
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	TIMOLOL MALEATE TABLET [MYLAN PHARMACEUTICALS INC.]	5
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	TIMOLOL MALEATE TABLET [MYLAN PHARMACEUTICALS INC.]	5
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	TIMOLOL MALEATE TABLET [MYLAN PHARMACEUTICALS INC.]	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0378-0055	TIMOLOL MALEATE TABLET [MYLAN PHARMACEUTICALS INC.]	10	Legacy NDC, 1 package rows	20250522_57c62928-63d8-4505-9b9e-c085a3a12c95.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	Mylan Pharmaceuticals Inc.	57c62928-63d8-4505-9b9e-c085a3a12c95	2020-07-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 072668 application number: ANDA072668 ndc (product): 0378-0055

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
198284	timolol maleate 10 MG Oral Tablet	PSN	57c62928-63d8-4505-9b9e-c085a3a12c95	10
198285	timolol maleate 20 MG Oral Tablet	PSN	57c62928-63d8-4505-9b9e-c085a3a12c95	10
198286	timolol maleate 5 MG Oral Tablet	PSN	57c62928-63d8-4505-9b9e-c085a3a12c95	10
198284	timolol 10 MG Oral Tablet	SCD	57c62928-63d8-4505-9b9e-c085a3a12c95	10
198285	timolol 20 MG Oral Tablet	SCD	57c62928-63d8-4505-9b9e-c085a3a12c95	10
198286	timolol 5 MG Oral Tablet	SCD	57c62928-63d8-4505-9b9e-c085a3a12c95	10
198284	timolol 10 MG (as maleate) Oral Tablet	SY	57c62928-63d8-4505-9b9e-c085a3a12c95	10
198285	timolol 20 MG (as maleate) Oral Tablet	SY	57c62928-63d8-4505-9b9e-c085a3a12c95	10
198286	timolol 5 MG (as maleate) Oral Tablet	SY	57c62928-63d8-4505-9b9e-c085a3a12c95	10
198286	timolol maleate 5 MG Oral Tablet	PSN	e36b1d3f-ee05-4735-a340-6e83a91ded41	1
198286	timolol 5 MG Oral Tablet	SCD	e36b1d3f-ee05-4735-a340-6e83a91ded41	1
198286	timolol 5 MG (as maleate) Oral Tablet	SY	e36b1d3f-ee05-4735-a340-6e83a91ded41	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0378-0055-01	00378005501	100 TABLET in 1 BOTTLE, PLASTIC (0378-0055-01)	100 tablet	1990-06-08	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Timolol Maleate - Mylan Pharmaceuticals Inc.	Mylan Pharmaceuticals Inc.	2020-07-06	HUMAN PRESCRIPTION DRUG LABEL	10
Timolol Maleate - Avera McKennan Hospital	Avera McKennan Hospital	2017-03-15	HUMAN PRESCRIPTION DRUG LABEL	1