Timolol Maleate Ophthalmic Solution

Manufacturer: Holopack Verpackungstechnik GmbH
Effective date: 2022-02-04
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 1
Source: legacy-cache
Hydrated at: 2026-08-01 22:02:57

Label at a glance#

ProductTimolol Maleate Ophthalmic Solution

Active ingredientTIMOLOL MALEATE

Label structure2 sections

Contacts and useful links#

Websitewww.amringusa.com

www.amringusa.com

Label contents#

Full prescribing information#

Timolol Maleate Ophthalmic Solution

SPL UNCLASSIFIED SECTION

Timolol Maleate Ophthalmic Solution

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Timolol Maleate Ophthalmic Solution, USP

0.25%

Rx only

NCD Code 69918-602-60

Store at Room Temperature 15-30 ºC (59-86 ºF)

Mfd. For:

Amring Pharmaceuticals Inc.

Berwyn, PA 19312

www.amringusa.com

Mfd. By:

Holopack Verpackungstechnik GmbH

Bahnhofstr., 74429 Sulzbach-Laufen

Germany

Holopack Material No.: 011-01561

EXP 03/2022 LOT TEST02 QTY 30

(17)220331(10)TEST02(30)30

(01)30369918602609(21)123456789012

Printing date: 2022-04-06

Timolol25

Timolol Maleate Ophthalmic Solution, USP

0.5%

Rx only

NCD Code 69918-601-60

Store at Room Temperature 15-30 ºC (59-86 ºF)

Mfd. For:

Amring Pharmaceuticals Inc.

Berwyn, PA 19312

www.amringusa.com

Mfd. By:

Holopack Verpackungstechnik GmbH

Bahnhofstr., 74429 Sulzbach-Laufen

Germany

Holopack Material No.: 011-01561

EXP 03/2022 LOT TEST02 QTY 30

(17)220331(10)TEST02(30)30

(01)30369918601602(21)123456789012

Printing date: 2022-04-06

Timolol50

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 8 matching rows.

Timolol Maleate Ophthalmic Solution
Timolol Maleate
WATER
TROMETHAMINE
BENZODODECINIUM BROMIDE
TIMOLOL ANHYDROUS
MANNITOL
GELLAN GUM (LOW ACYL)

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
60940-039	60940-039-01
60940-038	60940-038-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
WATER	059QF0KO0R	IACT
TROMETHAMINE	023C2WHX2V	IACT
BENZODODECINIUM BROMIDE	IRY12B2TQ6	IACT
TIMOLOL MALEATE	P8Y54F701R	ACTIM
MANNITOL	3OWL53L36A	IACT
GELLAN GUM (LOW ACYL)	7593U09I4D	IACT
TROMETHAMINE	023C2WHX2V	IACT
GELLAN GUM (LOW ACYL)	7593U09I4D	IACT
BENZODODECINIUM BROMIDE	IRY12B2TQ6	IACT
MANNITOL	3OWL53L36A	IACT
WATER	059QF0KO0R	IACT
TIMOLOL MALEATE	P8Y54F701R	ACTIM

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A212592-001	TIMOLOL MALEATE	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3		2021-12-13
A212592-002	TIMOLOL MALEATE	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3		2021-12-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A212592-001	AT3
A212592-002	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 2 · 68 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
2026-09-14 22:38:34	2026-08	A212592-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	2021-12-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212592-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	2021-12-13	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A212592-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	2021-12-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212592-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	2021-12-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212592-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	2021-12-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212592-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	2021-12-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212592-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	2021-12-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212592-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	2021-12-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212592-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	2021-12-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212592-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	2021-12-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212592-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	2021-12-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212592-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	2021-12-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212592-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	2021-12-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212592-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	2021-12-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212592-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	2021-12-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212592-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	2021-12-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212592-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	2021-12-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212592-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	2021-12-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212592-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	2021-12-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212592-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	2021-12-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212592-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	2021-12-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212592-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	2021-12-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212592-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	2021-12-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212592-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	2021-12-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212592-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	2021-12-13	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212592-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	2021-12-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212592-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	2021-12-13	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212592-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	2021-12-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212592-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	2021-12-13	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212592-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	2021-12-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212592-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	2021-12-13	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A212592-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	2021-12-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212592-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	2021-12-13	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212592-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	2021-12-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212592-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	2021-12-13	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A212592-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	2021-12-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212592-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	2021-12-13	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A212592-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	2021-12-13	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212592-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	2021-12-13	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A212592-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	2021-12-13	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 68 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A212592-001	AT3	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212592-002	AT3	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A212592-001	AT3	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212592-002	AT3	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212592-001	AT3	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212592-002	AT3	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212592-001	AT3	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212592-002	AT3	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212592-001	AT3	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212592-002	AT3	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212592-001	AT3	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212592-002	AT3	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212592-001	AT3	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212592-002	AT3	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212592-001	AT3	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212592-002	AT3	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212592-001	AT3	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212592-002	AT3	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212592-001	AT3	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212592-002	AT3	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212592-001	AT3	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212592-002	AT3	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212592-001	AT3	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212592-002	AT3	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212592-001	AT3	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212592-002	AT3	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212592-001	AT3	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212592-002	AT3	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212592-001	AT3	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212592-002	AT3	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212592-001	AT3	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A212592-002	AT3	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212592-001	AT3	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212592-002	AT3	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212592-001	AT3	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A212592-002	AT3	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212592-001	AT3	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A212592-002	AT3	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212592-001	AT3	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A212592-002	AT3	1	`bb7c543d1eb4…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212592-001	CGT	2022-08-25	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212592-002	CGT	2022-08-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212592-001	CGT	2022-08-25	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A212592-002	CGT	2022-08-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212592-001	CGT	2022-08-25	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A212592-002	CGT	2022-08-25	`4b0b4de00fa7…`
2023-01-26 05:58 UTC	2023-01	A212592-001	CGT	2022-08-25	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A212592-002	CGT	2022-08-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212592-001	CGT	2022-08-25	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212592-002	CGT	2022-08-25	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212592-001	CGT	2022-08-25	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A212592-002	CGT	2022-08-25	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212592-001	CGT	2022-08-25	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A212592-002	CGT	2022-08-25	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212592-001	CGT	2022-08-25	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212592-002	CGT	2022-08-25	`cb3db0bc1861…`

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
d737b1e7-6b7d-1cec-e053-2995a90afe21			d737b1e7-6b7c-1cec-e053-2995a90afe21	2022-02-04		Exact identifier spl id: d737b1e7-6b7d-1cec-e053-2995a90afe21 spl set id: d737b1e7-6b7c-1cec-e053-2995a90afe21

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.