Timolol GFS

Product NDC: 61314-225
11-digit product format: 613140225
Labeler code: 61314
Product ID: 61314-225_ba538348-67cf-4031-84e5-cb84647af104
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: timolol maleate
Dosage form: SOLUTION, GEL FORMING / DROPS
Route: OPHTHALMIC
Labeler: Sandoz Inc
Application: NDA020963
Marketing category: NDA
Marketing start: 1998-12-24
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: 2026-12-31
Current FDA listing: Yes

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

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
N020963-001	TIMOLOL MALEATE	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RLD, RS	1998-10-21
N020963-002	TIMOLOL MALEATE	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RLD, RS	1998-10-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N020963-001	AB
N020963-002	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 · 84 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	N020963-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RLD, RS	1998-10-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020963-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RLD, RS	1998-10-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020963-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RLD, RS	1998-10-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020963-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RLD, RS	1998-10-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020963-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RLD, RS	1998-10-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020963-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RLD, RS	1998-10-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020963-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RLD, RS	1998-10-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020963-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RLD, RS	1998-10-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020963-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RLD, RS	1998-10-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020963-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RLD, RS	1998-10-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020963-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RLD, RS	1998-10-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020963-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RLD, RS	1998-10-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020963-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RLD, RS	1998-10-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020963-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RLD, RS	1998-10-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020963-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RLD, RS	1998-10-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020963-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RLD, RS	1998-10-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020963-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RLD, RS	1998-10-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020963-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RLD, RS	1998-10-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020963-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RLD, RS	1998-10-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020963-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RLD, RS	1998-10-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020963-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RLD, RS	1998-10-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020963-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RLD, RS	1998-10-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020963-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RLD, RS	1998-10-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020963-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RLD, RS	1998-10-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020963-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RLD, RS	1998-10-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020963-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RLD, RS	1998-10-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020963-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RLD, RS	1998-10-21	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020963-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RLD, RS	1998-10-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020963-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RLD, RS	1998-10-21	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020963-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RLD, RS	1998-10-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020963-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RLD, RS	1998-10-21	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020963-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RLD, RS	1998-10-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020963-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RLD, RS	1998-10-21	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020963-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RLD, RS	1998-10-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020963-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RLD, RS	1998-10-21	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020963-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RLD, RS	1998-10-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020963-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB		1998-10-21	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020963-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB		1998-10-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020963-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RLD, RS	1998-10-21	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020963-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RLD, RS	1998-10-21	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 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	N020963-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020963-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020963-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020963-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020963-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020963-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020963-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020963-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020963-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020963-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020963-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020963-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020963-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020963-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020963-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020963-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020963-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020963-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020963-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020963-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020963-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020963-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020963-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020963-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020963-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020963-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020963-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020963-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020963-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020963-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020963-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020963-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020963-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020963-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020963-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020963-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020963-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020963-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020963-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020963-002	AB	1	`bb7c543d1eb4…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N020963-001	6174524	2019-03-26	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020963-001	6174524*PED	2019-09-26	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020963-002	6174524	2019-03-26	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020963-002	6174524*PED	2019-09-26	Pediatric extension	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	N020963-001	6174524	2019-03-26	Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020963-001	6174524*PED	2019-09-26	Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020963-002	6174524	2019-03-26	Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020963-002	6174524*PED	2019-09-26	Pediatric extension	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020963-001	6174524	2019-03-26	Drug product	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N020963-001	6174524*PED	2019-09-26	Pediatric extension	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N020963-002	6174524	2019-03-26	Drug product	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N020963-002	6174524*PED	2019-09-26	Pediatric extension	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020963-001	6174524	2019-03-26	Drug product	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N020963-001	6174524*PED	2019-09-26	Pediatric extension	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N020963-002	6174524	2019-03-26	Drug product	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N020963-002	6174524*PED	2019-09-26	Pediatric extension	`ea99ee380514…`

Additional Listing Data#

Finished product: Yes
Brand name base: Timolol GFS
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TIMOLOL MALEATE	5 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
P8Y54F701R	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
313407	Internal RxNorm lookup
313408	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
72b0d0ec-832a-4c25-b845-2537ab506354	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
c6c0c444-a6ba-2fb5-a7bc-7f0443fa5791	Product name	4	20251208
77dc03a4-fbfc-e6a3-fe95-285bbae40d75	Product name	2	20250814
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, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
61314-225-05	2024-01-30	C162847	48780-1	1030e365-01bc-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use Timolol GFS safely and effectively. See full prescribing information for Timolol GFS. Timolol GFS (timolol maleate ophthalmic gel forming solution) 0.25% and 0.5%, for topical ophthalmic use. Initial U.S. Approval: 1978
61314-225-25	2024-01-30	C162847	48780-1	1030e365-01bc-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use Timolol GFS safely and effectively. See full prescribing information for Timolol GFS. Timolol GFS (timolol maleate ophthalmic gel forming solution) 0.25% and 0.5%, for topical ophthalmic use. Initial U.S. Approval: 1978

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
61314-225-05	Timolol GFS	5 mL in 1 BOTTLE	SOLUTION, GEL FORMING / DROPS	5		15
61314-225-25	Timolol GFS	2.5 mL in 1 BOTTLE	SOLUTION, GEL FORMING / DROPS	2.5		15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
61314-225-05	ML - Milliliter	61314-225	083ae698-a00c-4fa4-8706-7c3551ea4908	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
TIMOLOL MALEATE	ACTIVE INGREDIENT	P8Y54F701R	TIMOLOL GFS (TIMOLOL MALEATE) SOLUTION, GEL FORMING, EXTENDED RELEASE [SANDOZ INC]	10
TIMOLOL ANHYDROUS	ACTIVE MOIETY	5JKY92S7BR	TIMOLOL GFS (TIMOLOL MALEATE) SOLUTION, GEL FORMING, EXTENDED RELEASE [SANDOZ INC]	10
BENZODODECINIUM BROMIDE	INACTIVE INGREDIENT	IRY12B2TQ6	TIMOLOL GFS (TIMOLOL MALEATE) SOLUTION, GEL FORMING, EXTENDED RELEASE [SANDOZ INC]	10
BORIC ACID	INACTIVE INGREDIENT	R57ZHV85D4	TIMOLOL GFS (TIMOLOL MALEATE) SOLUTION, GEL FORMING, EXTENDED RELEASE [SANDOZ INC]	10
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	TIMOLOL GFS (TIMOLOL MALEATE) SOLUTION, GEL FORMING, EXTENDED RELEASE [SANDOZ INC]	10
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	TIMOLOL GFS (TIMOLOL MALEATE) SOLUTION, GEL FORMING, EXTENDED RELEASE [SANDOZ INC]	10
TROMETHAMINE	INACTIVE INGREDIENT	023C2WHX2V	TIMOLOL GFS (TIMOLOL MALEATE) SOLUTION, GEL FORMING, EXTENDED RELEASE [SANDOZ INC]	10
WATER	INACTIVE INGREDIENT	059QF0KO0R	TIMOLOL GFS (TIMOLOL MALEATE) SOLUTION, GEL FORMING, EXTENDED RELEASE [SANDOZ INC]	10
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	TIMOLOL GFS (TIMOLOL MALEATE) SOLUTION, GEL FORMING, EXTENDED RELEASE [SANDOZ INC]	10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61314-225	TIMOLOL GFS (TIMOLOL MALEATE) SOLUTION, GEL FORMING / DROPS [SANDOZ INC]	15	Current NDC, Legacy NDC, 2 package rows	20240608_72b0d0ec-832a-4c25-b845-2537ab506354.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 GFS	TIMOLOL MALEATE	Sandoz Inc	72b0d0ec-832a-4c25-b845-2537ab506354	2024-05-28	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020963 application number: NDA020963 ndc (product): 61314-225

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
313407	timolol maleate 0.25 % Ophthalmic Gel Forming Solution	PSN	72b0d0ec-832a-4c25-b845-2537ab506354	15
313408	timolol maleate 0.5 % Ophthalmic Gel Forming Solution	PSN	72b0d0ec-832a-4c25-b845-2537ab506354	15
313407	timolol 0.0025 MG/MG Ophthalmic Gel	SCD	72b0d0ec-832a-4c25-b845-2537ab506354	15
313408	timolol 0.005 MG/MG Ophthalmic Gel	SCD	72b0d0ec-832a-4c25-b845-2537ab506354	15
313407	timolol 0.25 % Ophthalmic Gel	SY	72b0d0ec-832a-4c25-b845-2537ab506354	15
313407	timolol 0.25 % Ophthalmic Gel Forming Solution	SY	72b0d0ec-832a-4c25-b845-2537ab506354	15
313408	timolol 0.5 % (as timolol maleate 6.8 MG/ML) Ophthalmic Gel	SY	72b0d0ec-832a-4c25-b845-2537ab506354	15
313408	timolol 0.5 % Gel Forming Ophthalmic Solution	SY	72b0d0ec-832a-4c25-b845-2537ab506354	15

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
61314-225-05	61314022505	5 mL in 1 BOTTLE (61314-225-05)	5 ml	1998-12-24	0000-00-00	No	No	Current
61314-225-25	61314022525	2.5 mL in 1 BOTTLE (61314-225-25)	2.5 ml	1998-12-24	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Timolol GFS	Bryant Ranch Prepack	2024-07-17	HUMAN PRESCRIPTION DRUG LABEL	101
Timolol GFS	Sandoz Inc	2024-05-28	HUMAN PRESCRIPTION DRUG LABEL	15