TIMOLOL MALEATE

Product NDC
55545-1000
11-digit product format
555451000
Labeler code
55545
Product ID
55545-1000_a4cd6743-0942-4ae6-b2d4-8a23786b86d4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
timolol maleate
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
FDC Limited
Application
ANDA077259
Marketing category
ANDA
Marketing start
2014-12-15
Marketing end
0000-00-00
Substance
TIMOLOL MALEATE
Active strength
3 mg/mL
Pharmacologic classes
Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A077259-001TIMOLOL MALEATETIMOLOL MALEATEEQ 0.25% BASESOLUTION/DROPS / OPHTHALMICAT12008-04-30
A077259-002TIMOLOL MALEATETIMOLOL MALEATEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12008-04-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A077259-001AT1
A077259-002AT1

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 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A077259-001TIMOLOL MALEATEEQ 0.25% BASESOLUTION/DROPS / OPHTHALMICAT12008-04-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077259-002TIMOLOL MALEATEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12008-04-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077259-001TIMOLOL MALEATEEQ 0.25% BASESOLUTION/DROPS / OPHTHALMICAT12008-04-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077259-002TIMOLOL MALEATEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12008-04-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A077259-001TIMOLOL MALEATEEQ 0.25% BASESOLUTION/DROPS / OPHTHALMICAT12008-04-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077259-002TIMOLOL MALEATEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12008-04-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077259-001TIMOLOL MALEATEEQ 0.25% BASESOLUTION/DROPS / OPHTHALMICAT12008-04-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077259-002TIMOLOL MALEATEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12008-04-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077259-001TIMOLOL MALEATEEQ 0.25% BASESOLUTION/DROPS / OPHTHALMICAT12008-04-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077259-002TIMOLOL MALEATEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12008-04-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077259-001TIMOLOL MALEATEEQ 0.25% BASESOLUTION/DROPS / OPHTHALMICAT12008-04-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077259-002TIMOLOL MALEATEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12008-04-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077259-001TIMOLOL MALEATEEQ 0.25% BASESOLUTION/DROPS / OPHTHALMICAT12008-04-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077259-002TIMOLOL MALEATEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12008-04-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077259-001TIMOLOL MALEATEEQ 0.25% BASESOLUTION/DROPS / OPHTHALMICAT12008-04-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077259-002TIMOLOL MALEATEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12008-04-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077259-001TIMOLOL MALEATEEQ 0.25% BASESOLUTION/DROPS / OPHTHALMICAT12008-04-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077259-002TIMOLOL MALEATEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12008-04-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077259-001TIMOLOL MALEATEEQ 0.25% BASESOLUTION/DROPS / OPHTHALMICAT12008-04-30d06236e962d9…
2024-10-29 15:01 UTC2024-10A077259-002TIMOLOL MALEATEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12008-04-30d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077259-001TIMOLOL MALEATEEQ 0.25% BASESOLUTION/DROPS / OPHTHALMICAT12008-04-3079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077259-002TIMOLOL MALEATEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12008-04-3079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077259-001TIMOLOL MALEATEEQ 0.25% BASESOLUTION/DROPS / OPHTHALMICAT12008-04-30301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077259-002TIMOLOL MALEATEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12008-04-30301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077259-001TIMOLOL MALEATEEQ 0.25% BASESOLUTION/DROPS / OPHTHALMICAT12008-04-301e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077259-002TIMOLOL MALEATEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12008-04-301e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077259-001TIMOLOL MALEATEEQ 0.25% BASESOLUTION/DROPS / OPHTHALMICAT12008-04-308072bd15b7f6…
2024-05-31 18:47 UTC2024-05A077259-002TIMOLOL MALEATEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12008-04-308072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077259-001TIMOLOL MALEATEEQ 0.25% BASESOLUTION/DROPS / OPHTHALMICAT12008-04-305c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077259-002TIMOLOL MALEATEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12008-04-305c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077259-001TIMOLOL MALEATEEQ 0.25% BASESOLUTION/DROPS / OPHTHALMICAT12008-04-305d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A077259-002TIMOLOL MALEATEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12008-04-305d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077259-001TIMOLOL MALEATEEQ 0.25% BASESOLUTION/DROPS / OPHTHALMICAT12008-04-304b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A077259-002TIMOLOL MALEATEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12008-04-304b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077259-001TIMOLOL MALEATEEQ 0.25% BASESOLUTION/DROPS / OPHTHALMICAT2008-04-3074a2ff9319b5…
2019-12-13 00:20 UTC2019-12A077259-002TIMOLOL MALEATEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12008-04-3074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077259-001TIMOLOL MALEATEEQ 0.25% BASESOLUTION/DROPS / OPHTHALMICAT12008-04-30bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A077259-002TIMOLOL MALEATEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12008-04-30bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A077259-001TIMOLOL MALEATEEQ 0.25% BASESOLUTION/DROPS / OPHTHALMICAT2008-04-30782e0a99824c…
2021-12-28 21:50 UTC2021-12A077259-002TIMOLOL MALEATEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12008-04-30782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A077259-001AT11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077259-002AT11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077259-001AT1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077259-002AT1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077259-001AT116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077259-002AT116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077259-001AT11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077259-002AT11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077259-001AT11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077259-002AT11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077259-001AT1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077259-002AT1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077259-001AT112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077259-002AT112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077259-001AT115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077259-002AT115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077259-001AT11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077259-002AT11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077259-001AT11d06236e962d9…
2024-10-29 15:01 UTC2024-10A077259-002AT11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077259-001AT1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077259-002AT1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077259-001AT11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077259-002AT11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077259-001AT111e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077259-002AT111e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077259-001AT118072bd15b7f6…
2024-05-31 18:47 UTC2024-05A077259-002AT118072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077259-001AT115c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077259-002AT115c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077259-001AT115d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A077259-002AT115d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077259-001AT114b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A077259-002AT114b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077259-001AT174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A077259-002AT1174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077259-001AT11bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A077259-002AT11bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A077259-001AT1782e0a99824c…
2021-12-28 21:50 UTC2021-12A077259-002AT11782e0a99824c…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6c0c444-a6ba-2fb5-a7bc-7f0443fa5791Product name420251208
73103a56-9f57-4f32-a306-a42bfa2fea36Product name120250505
425025fc-f910-4afe-815b-58d4486ed4f7Product name420250331
26c5ddae-5c69-622d-e599-5fd583634968Product name420250313
ee780602-134c-4c60-a2f0-e973ba549cd4Product name220250304
03f77cb2-b4ad-3c11-8781-787b5ece4291Product name320240507
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
273981e4-09e7-45cc-967c-554f628ededfProduct name320230627
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
97dad5a2-c524-a7b5-dede-82edefe9ce62Product name720220929
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
d11e749b-f93e-0ce3-ceda-28fe03d8081dProduct name220190731
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55545-1000-1TIMOLOL MALEATE1 in 1 CARTONSOLUTION/ DROPS13
55545-1000-1TIMOLOL MALEATE5 mL in 1 BOTTLESOLUTION/ DROPS53
55545-1000-2TIMOLOL MALEATE10 mL in 1 BOTTLESOLUTION/ DROPS103
55545-1000-2TIMOLOL MALEATE1 in 1 CARTONSOLUTION/ DROPS13
55545-1000-3TIMOLOL MALEATE1 in 1 CARTONSOLUTION/ DROPS13
55545-1000-3TIMOLOL MALEATE15 mL in 1 BOTTLESOLUTION/ DROPS153

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TIMOLOL MALEATEACTIVE INGREDIENTP8Y54F701RTIMOLOL MALEATE SOLUTION/ DROPS [FDC LIMITED]2
TIMOLOL ANHYDROUSACTIVE MOIETY5JKY92S7BRTIMOLOL MALEATE SOLUTION/ DROPS [FDC LIMITED]2
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7TIMOLOL MALEATE SOLUTION/ DROPS [FDC LIMITED]2
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XTIMOLOL MALEATE SOLUTION/ DROPS [FDC LIMITED]2
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ITIMOLOL MALEATE SOLUTION/ DROPS [FDC LIMITED]2
SODIUM PHOSPHATE, DIBASICINACTIVE INGREDIENTGR686LBA74TIMOLOL MALEATE SOLUTION/ DROPS [FDC LIMITED]2
SODIUM PHOSPHATE, MONOBASICINACTIVE INGREDIENT3980JIH2SWTIMOLOL MALEATE SOLUTION/ DROPS [FDC LIMITED]2
WATERINACTIVE INGREDIENT059QF0KO0RTIMOLOL MALEATE SOLUTION/ DROPS [FDC LIMITED]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55545-1000TIMOLOL MALEATE SOLUTION/ DROPS [FDC LIMITED]3Legacy NDC, 6 package rows20171122_2101d051-411e-466c-bba6-166a4615b17b.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TIMOLOL MALEATETIMOLOL MALEATERising Pharma Holdings, Inc.2ed21930-1e05-46de-8acd-cb6f4798a7fa2025-05-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077259
application number: ANDA077259

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1923428timolol maleate 0.25 % Ophthalmic SolutionPSN2101d051-411e-466c-bba6-166a4615b17b3
1923428timolol 2.5 MG/ML Ophthalmic SolutionSCD2101d051-411e-466c-bba6-166a4615b17b3
1923428timolol 0.25 % Ophthalmic SolutionSY2101d051-411e-466c-bba6-166a4615b17b3
1923428timolol 2.5 MG/ML (as timolol maleate 3.4 MG/ML) Ophthalmic SolutionSY2101d051-411e-466c-bba6-166a4615b17b3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
55545-1000-1555451000011 in 1 CARTONHistorical
55545-1000-25554510000210 mL in 1 BOTTLE10 mlHistorical
55545-1000-3555451000031 in 1 CARTONHistorical