Timolol Maleate

Product NDC: 61314-227
11-digit product format: 613140227
Labeler code: 61314
Product ID: 61314-227_d1f4cdca-5a1b-4eb3-8b00-fa7d778bb1c0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Timolol Maleate
Dosage form: SOLUTION
Route: OPHTHALMIC
Labeler: Sandoz Inc
Application: ANDA074262
Marketing category: ANDA
Marketing start: 1996-01-15
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A074262-001	TIMOLOL MALEATE	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	RS	1995-04-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A074262-001	AT1

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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A074262-001	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	RS	1995-04-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074262-001	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	RS	1995-04-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074262-001	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	RS	1995-04-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074262-001	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	RS	1995-04-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074262-001	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	RS	1995-04-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074262-001	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	RS	1995-04-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074262-001	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	RS	1995-04-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074262-001	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	RS	1995-04-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074262-001	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	RS	1995-04-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074262-001	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	RS	1995-04-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074262-001	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	RS	1995-04-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074262-001	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	RS	1995-04-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074262-001	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	RS	1995-04-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074262-001	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	RS	1995-04-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074262-001	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	RS	1995-04-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074262-001	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	RS	1995-04-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074262-001	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	RS	1995-04-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074262-001	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	RS	1995-04-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074262-001	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	RS	1995-04-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074262-001	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	RS	1995-04-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074262-001	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	RS	1995-04-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074262-001	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	RS	1995-04-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074262-001	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	RS	1995-04-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074262-001	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	RS	1995-04-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074262-001	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	RS	1995-04-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074262-001	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	RS	1995-04-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074262-001	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	RS	1995-04-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074262-001	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	RS	1995-04-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074262-001	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	RS	1995-04-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074262-001	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	RS	1995-04-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074262-001	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	RS	1995-04-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074262-001	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	RS	1995-04-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074262-001	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	RS	1995-04-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074262-001	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	RS	1995-04-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074262-001	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	RS	1995-04-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074262-001	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	RS	1995-04-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074262-001	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	RS	1995-04-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074262-001	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	RS	1995-04-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A074262-001	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	RS	1995-04-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A074262-001	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	RS	1995-04-28	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 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	A074262-001	AT1	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074262-001	AT1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074262-001	AT1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074262-001	AT1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074262-001	AT1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074262-001	AT1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074262-001	AT1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074262-001	AT1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074262-001	AT1	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074262-001	AT1	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074262-001	AT1	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074262-001	AT1	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074262-001	AT1	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074262-001	AT1	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074262-001	AT1	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074262-001	AT1	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074262-001	AT1	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074262-001	AT1	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074262-001	AT1	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074262-001	AT1	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074262-001	AT1	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074262-001	AT1	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074262-001	AT1	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074262-001	AT1	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074262-001	AT1	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074262-001	AT1	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074262-001	AT1	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074262-001	AT1	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074262-001	AT1	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074262-001	AT1	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074262-001	AT1	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074262-001	AT1	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074262-001	AT1	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074262-001	AT1	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074262-001	AT1	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074262-001	AT1	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074262-001	AT1	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074262-001	AT1	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A074262-001	AT1	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A074262-001	AT1	1	`e64feba35796…`

Additional Listing Data#

Finished product: Yes
Brand name base: Timolol Maleate
Listing expiration: 2027-12-31

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
1923428	Internal RxNorm lookup
1992303	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
f949fa34-6a9a-40d5-91ab-ff1cbb79b9ea	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
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, Related label table
NDC	Effective	Related label
61314-227-05	2024-08-16	Timolol Maleate Ophthalmic Solution, USP 0.25% and 0.5% STERILE Rx Only
61314-227-05	2024-08-16	Timolol Maleate Ophthalmic Solution, USP 0.25% and 0.5% STERILE Rx Only
61314-227-10	2024-08-16	Timolol Maleate Ophthalmic Solution, USP 0.25% and 0.5% STERILE Rx Only
61314-227-10	2024-08-16	Timolol Maleate Ophthalmic Solution, USP 0.25% and 0.5% STERILE Rx Only
61314-227-15	2024-08-16	Timolol Maleate Ophthalmic Solution, USP 0.25% and 0.5% STERILE Rx Only
61314-227-15	2024-08-16	Timolol Maleate Ophthalmic Solution, USP 0.25% and 0.5% STERILE Rx Only
61314-227-05	2024-07-30	Timolol Maleate Ophthalmic Solution, USP 0.25% and 0.5% STERILE Rx Only
61314-227-05	2024-07-30	Timolol Maleate Ophthalmic Solution, USP 0.25% and 0.5% STERILE Rx Only
61314-227-10	2024-07-30	Timolol Maleate Ophthalmic Solution, USP 0.25% and 0.5% STERILE Rx Only
61314-227-10	2024-07-30	Timolol Maleate Ophthalmic Solution, USP 0.25% and 0.5% STERILE Rx Only
61314-227-15	2024-07-30	Timolol Maleate Ophthalmic Solution, USP 0.25% and 0.5% STERILE Rx Only
61314-227-15	2024-07-30	Timolol Maleate Ophthalmic Solution, USP 0.25% and 0.5% STERILE Rx Only
61314-227-05	2024-01-30	Timolol Maleate Ophthalmic Solution, USP 0.25% and 0.5% STERILE Rx Only
61314-227-05	2024-01-30	Timolol Maleate Ophthalmic Solution, USP 0.25% and 0.5% STERILE Rx Only
61314-227-10	2024-01-30	Timolol Maleate Ophthalmic Solution, USP 0.25% and 0.5% STERILE Rx Only
61314-227-10	2024-01-30	Timolol Maleate Ophthalmic Solution, USP 0.25% and 0.5% STERILE Rx Only
61314-227-15	2024-01-30	Timolol Maleate Ophthalmic Solution, USP 0.25% and 0.5% STERILE Rx Only
61314-227-15	2024-01-30	Timolol Maleate Ophthalmic Solution, USP 0.25% and 0.5% STERILE Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
61314-227-05	Timolol Maleate	5 mL in 1 BOTTLE, PLASTIC	SOLUTION	5	9
61314-227-10	Timolol Maleate	10 mL in 1 BOTTLE, PLASTIC	SOLUTION	10	9
61314-227-15	Timolol Maleate	15 mL in 1 BOTTLE, PLASTIC	SOLUTION	15	9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
61314-227-05	ML - Milliliter	61314-227	12435cc7-148e-449b-b0c1-a070c4abac16	1	2012-07-24
61314-227-10	ML - Milliliter	61314-227	799e2b27-0cc3-45d7-9e13-6cc286dbf699	1	2012-07-24
61314-227-15	ML - Milliliter	61314-227	f423eaee-a27f-4a3f-a3c3-d721664ff996	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 [SANDOZ INC]	3
TIMOLOL ANHYDROUS	ACTIVE MOIETY	5JKY92S7BR	TIMOLOL MALEATE SOLUTION [SANDOZ INC]	3
BENZALKONIUM CHLORIDE	INACTIVE INGREDIENT	F5UM2KM3W7	TIMOLOL MALEATE SOLUTION [SANDOZ INC]	3
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	TIMOLOL MALEATE SOLUTION [SANDOZ INC]	3
SODIUM PHOSPHATE, DIBASIC	INACTIVE INGREDIENT	GR686LBA74	TIMOLOL MALEATE SOLUTION [SANDOZ INC]	3
SODIUM PHOSPHATE, MONOBASIC	INACTIVE INGREDIENT	3980JIH2SW	TIMOLOL MALEATE SOLUTION [SANDOZ INC]	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	TIMOLOL MALEATE SOLUTION [SANDOZ INC]	3
TIMOLOL MALEATE	ACTIVE INGREDIENT	P8Y54F701R	TIMOLOL MALEATE SOLUTION [PHYSICIANS TOTAL CARE, INC.]	1
TIMOLOL ANHYDROUS	ACTIVE MOIETY	5JKY92S7BR	TIMOLOL MALEATE SOLUTION [PHYSICIANS TOTAL CARE, INC.]	1
BENZALKONIUM CHLORIDE	INACTIVE INGREDIENT	F5UM2KM3W7	TIMOLOL MALEATE SOLUTION [PHYSICIANS TOTAL CARE, INC.]	1
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	TIMOLOL MALEATE SOLUTION [PHYSICIANS TOTAL CARE, INC.]	1
SODIUM PHOSPHATE, DIBASIC	INACTIVE INGREDIENT	GR686LBA74	TIMOLOL MALEATE SOLUTION [PHYSICIANS TOTAL CARE, INC.]	1
SODIUM PHOSPHATE, MONOBASIC	INACTIVE INGREDIENT	3980JIH2SW	TIMOLOL MALEATE SOLUTION [PHYSICIANS TOTAL CARE, INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	TIMOLOL MALEATE SOLUTION [PHYSICIANS TOTAL CARE, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61314-227	TIMOLOL MALEATE SOLUTION [SANDOZ INC]	9	Current NDC, Legacy NDC, 3 package rows	20240817_f949fa34-6a9a-40d5-91ab-ff1cbb79b9ea.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	Sandoz Inc	f949fa34-6a9a-40d5-91ab-ff1cbb79b9ea	2026-02-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074262 application number: ANDA074262 ndc (product): 61314-227
Timolol Maleate	TIMOLOL MALEATE	A-S Medication Solutions	5305a38e-d9c8-4f9e-bf67-b246abc82cb1	2024-12-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074262 application number: ANDA074262

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	f949fa34-6a9a-40d5-91ab-ff1cbb79b9ea	9
1923428	timolol maleate 0.25 % Ophthalmic Solution	PSN	f949fa34-6a9a-40d5-91ab-ff1cbb79b9ea	9
1992303	12 HR timolol 5 MG/ML Ophthalmic Solution	SCD	f949fa34-6a9a-40d5-91ab-ff1cbb79b9ea	9
1923428	timolol 2.5 MG/ML Ophthalmic Solution	SCD	f949fa34-6a9a-40d5-91ab-ff1cbb79b9ea	9
1923428	timolol 0.25 % Ophthalmic Solution	SY	f949fa34-6a9a-40d5-91ab-ff1cbb79b9ea	9
1992303	timolol 0.5 % (as timolol maleate 6.8 MG/ML) 12 HR Ophthalmic Solution	SY	f949fa34-6a9a-40d5-91ab-ff1cbb79b9ea	9
1992303	timolol 0.5 % 12 HR Ophthalmic Solution	SY	f949fa34-6a9a-40d5-91ab-ff1cbb79b9ea	9
1923428	timolol 2.5 MG/ML (as timolol maleate 3.4 MG/ML) Ophthalmic Solution	SY	f949fa34-6a9a-40d5-91ab-ff1cbb79b9ea	9
1992303	timolol 0.5 % 12HR Ophthalmic Solution	PSN	5305a38e-d9c8-4f9e-bf67-b246abc82cb1	5
1992303	12 HR timolol 5 MG/ML Ophthalmic Solution	SCD	5305a38e-d9c8-4f9e-bf67-b246abc82cb1	5
1992303	timolol 0.5 % (as timolol maleate 6.8 MG/ML) 12 HR Ophthalmic Solution	SY	5305a38e-d9c8-4f9e-bf67-b246abc82cb1	5
1992303	timolol 0.5 % 12 HR Ophthalmic Solution	SY	5305a38e-d9c8-4f9e-bf67-b246abc82cb1	5
1992303	timolol 0.5 % 12HR Ophthalmic Solution	PSN	15732de7-64b9-4c42-897d-89ae1b330192	1
1923428	timolol maleate 0.25 % Ophthalmic Solution	PSN	15732de7-64b9-4c42-897d-89ae1b330192	1
1992303	12 HR timolol 5 MG/ML Ophthalmic Solution	SCD	15732de7-64b9-4c42-897d-89ae1b330192	1
1923428	timolol 2.5 MG/ML Ophthalmic Solution	SCD	15732de7-64b9-4c42-897d-89ae1b330192	1
1923428	timolol 0.25 % Ophthalmic Solution	SY	15732de7-64b9-4c42-897d-89ae1b330192	1
1992303	timolol 0.5 % (as timolol maleate 6.8 MG/ML) 12 HR Ophthalmic Solution	SY	15732de7-64b9-4c42-897d-89ae1b330192	1
1992303	timolol 0.5 % 12 HR Ophthalmic Solution	SY	15732de7-64b9-4c42-897d-89ae1b330192	1
1923428	timolol 2.5 MG/ML (as timolol maleate 3.4 MG/ML) Ophthalmic Solution	SY	15732de7-64b9-4c42-897d-89ae1b330192	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
61314-227-05	61314022705	5 mL in 1 BOTTLE, PLASTIC (61314-227-05)	5 ml	1996-01-15	0000-00-00	No	No	Current
61314-227-10	61314022710	10 mL in 1 BOTTLE, PLASTIC (61314-227-10)	10 ml	1996-01-15	0000-00-00	No	No	Current
61314-227-15	61314022715	15 mL in 1 BOTTLE, PLASTIC (61314-227-15)	15 ml	1996-01-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Timolol Maleate Ophthalmic Solution, USP 0.25% and 0.5% STERILE Rx Only	Sandoz Inc	2026-02-20	HUMAN PRESCRIPTION DRUG LABEL	10
Timolol Maleate Ophthalmic Solution, USP 0.25% and 0.5% STERILE Rx Only	A-S Medication Solutions	2024-12-20	HUMAN PRESCRIPTION DRUG LABEL	5
Timolol Maleate Ophthalmic Solution USP STERILE	Physicians Total Care, Inc.	2012-08-29	HUMAN PRESCRIPTION DRUG LABEL	1