Timolol Maleate

Product NDC: 17478-288
Requested package NDC: 17478-288-11
11-digit product format: 174780288
Labeler code: 17478
Product ID: 17478-288_f060b454-1334-42d7-ad91-266f34581ce8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Timolol Maleate
Dosage form: SOLUTION/ DROPS
Route: OPHTHALMIC
Labeler: Akorn
Application: ANDA074466
Marketing category: ANDA
Marketing start: 2012-03-26
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	17478-288	17478-288-11	I	Inactivated by FDA		2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 15 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`

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
A074466-001	TIMOLOL MALEATE	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC			1997-03-25

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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A074466-001	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		1997-03-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074466-001	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		1997-03-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074466-001	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		1997-03-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074466-001	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		1997-03-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074466-001	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		1997-03-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074466-001	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		1997-03-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074466-001	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		1997-03-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074466-001	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		1997-03-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074466-001	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		1997-03-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074466-001	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		1997-03-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074466-001	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		1997-03-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074466-001	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		1997-03-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074466-001	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		1997-03-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074466-001	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		1997-03-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074466-001	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		1997-03-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074466-001	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	1997-03-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074466-001	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	1997-03-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074466-001	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	1997-03-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074466-001	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	1997-03-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074466-001	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	1997-03-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074466-001	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	1997-03-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074466-001	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	1997-03-25	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074466-001	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	1997-03-25	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074466-001	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	1997-03-25	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074466-001	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	1997-03-25	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074466-001	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	1997-03-25	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074466-001	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	1997-03-25	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074466-001	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	1997-03-25	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074466-001	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		1997-03-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074466-001	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		1997-03-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074466-001	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		1997-03-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074466-001	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		1997-03-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074466-001	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		1997-03-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074466-001	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		1997-03-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074466-001	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		1997-03-25	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074466-001	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		1997-03-25	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074466-001	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	1997-03-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074466-001	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	1997-03-25	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A074466-001	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	1997-03-25	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A074466-001	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	1997-03-25	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074466-001	AT1	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074466-001	AT1	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074466-001	AT1	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074466-001	AT1	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074466-001	AT1	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074466-001	AT1	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074466-001	AT1	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074466-001	AT1	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074466-001	AT1	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074466-001	AT1	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074466-001	AT1	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074466-001	AT1	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074466-001	AT1	1	`ea99ee380514…`
2023-01-26 05:58 UTC	2023-01	A074466-001	AT1	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074466-001	AT1	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A074466-001	AT1	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A074466-001	AT1	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A074466-001	AT1	1	`cb3db0bc1861…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
17478-288-10	TIMOLOL MALEATE OPHTHALMIC SOLUTION, USP
17478-288-11	TIMOLOL MALEATE OPHTHALMIC SOLUTION, USP
17478-288-12	TIMOLOL MALEATE OPHTHALMIC SOLUTION, USP
17478-288-25	TIMOLOL MALEATE OPHTHALMIC SOLUTION, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
17478-288-10	Timolol Maleate	5 mL in 1 BOTTLE, DROPPER	SOLUTION/ DROPS	5	10
17478-288-10	Timolol Maleate	1 in 1 CARTON	SOLUTION/ DROPS	1	10
17478-288-11	Timolol Maleate	10 mL in 1 BOTTLE, DROPPER	SOLUTION/ DROPS	10	10
17478-288-11	Timolol Maleate	1 in 1 CARTON	SOLUTION/ DROPS	1	10
17478-288-12	Timolol Maleate	1 in 1 CARTON	SOLUTION/ DROPS	1	10
17478-288-12	Timolol Maleate	15 mL in 1 BOTTLE, DROPPER	SOLUTION/ DROPS	15	10
17478-288-25	Timolol Maleate	1 in 1 CARTON	SOLUTION/ DROPS	1	10
17478-288-25	Timolol Maleate	2.5 mL in 1 BOTTLE, DROPPER	SOLUTION/ DROPS	2.5	10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
17478-288-10	ML - Milliliter	17478-288	e8c583e5-0313-45b5-9021-d6aeb568a5e5	1	2012-07-24
17478-288-11	ML - Milliliter	17478-288	2af1912d-c5c4-447f-8a88-98bc79d468e0	1	2012-07-24
17478-288-12	ML - Milliliter	17478-288	19d1c7f5-5ba1-40c9-94e8-1d25a224956d	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 SOLUTION/ DROPS [AKORN, INC.]	4
Timolol Anhydrous	ACTIVE MOIETY	5JKY92S7BR	TIMOLOL MALEATE SOLUTION/ DROPS [AKORN, INC.]	4
Benzalkonium Chloride	INACTIVE INGREDIENT	F5UM2KM3W7	TIMOLOL MALEATE SOLUTION/ DROPS [AKORN, INC.]	4
Sodium Hydroxide	INACTIVE INGREDIENT	55X04QC32I	TIMOLOL MALEATE SOLUTION/ DROPS [AKORN, INC.]	4
Sodium Phosphate, Dibasic	INACTIVE INGREDIENT	GR686LBA74	TIMOLOL MALEATE SOLUTION/ DROPS [AKORN, INC.]	4
Sodium Phosphate, Monobasic	INACTIVE INGREDIENT	3980JIH2SW	TIMOLOL MALEATE SOLUTION/ DROPS [AKORN, INC.]	4
Water	INACTIVE INGREDIENT	059QF0KO0R	TIMOLOL MALEATE SOLUTION/ DROPS [AKORN, INC.]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
17478-288	TIMOLOL MALEATE SOLUTION/ DROPS [AKORN]	10	Legacy NDC, 8 package rows	20220524_c9726422-f794-4d39-a437-17dcb8c0f3b5.zip

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
1992303	timolol 0.5 % 12HR Ophthalmic Solution	PSN	c9726422-f794-4d39-a437-17dcb8c0f3b5	10
1923428	timolol maleate 0.25 % Ophthalmic Solution	PSN	c9726422-f794-4d39-a437-17dcb8c0f3b5	10
1992303	12 HR timolol 5 MG/ML Ophthalmic Solution	SCD	c9726422-f794-4d39-a437-17dcb8c0f3b5	10
1923428	timolol 2.5 MG/ML Ophthalmic Solution	SCD	c9726422-f794-4d39-a437-17dcb8c0f3b5	10
1923428	timolol 0.25 % Ophthalmic Solution	SY	c9726422-f794-4d39-a437-17dcb8c0f3b5	10
1992303	timolol 0.5 % (as timolol maleate 6.8 MG/ML) 12 HR Ophthalmic Solution	SY	c9726422-f794-4d39-a437-17dcb8c0f3b5	10
1992303	timolol 0.5 % 12 HR Ophthalmic Solution	SY	c9726422-f794-4d39-a437-17dcb8c0f3b5	10
1923428	timolol 2.5 MG/ML (as timolol maleate 3.4 MG/ML) Ophthalmic Solution	SY	c9726422-f794-4d39-a437-17dcb8c0f3b5	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
17478-288-11	17478028811	1 BOTTLE, DROPPER in 1 CARTON (17478-288-11) > 10 mL in 1 BOTTLE, DROPPER	2012-03-26	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
TIMOLOL MALEATE OPHTHALMIC SOLUTION, USP	A-S Medication Solutions	2023-02-04	HUMAN PRESCRIPTION DRUG LABEL	11
TIMOLOL MALEATE OPHTHALMIC SOLUTION, USP	Akorn \| Akorn Operating Company LLC	2022-05-23	HUMAN PRESCRIPTION DRUG LABEL	10
TIMOLOL MALEATE OPHTHALMIC SOLUTION, USP	NuCare Pharmaceuticals,Inc.	2017-07-26	HUMAN PRESCRIPTION DRUG LABEL	1