TIMOLOL MALEATE

Product NDC
60758-801
11-digit product format
607580801
Labeler code
60758
Product ID
60758-801_27ed7b7d-7640-4566-90f3-42a17a9d1a98
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
timolol maleate
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Pacific Pharma, Inc.
Application
ANDA074747
Marketing category
ANDA
Marketing start
1997-05-20
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
2027-12-31
Current FDA listing
Yes

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
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage60758-80160758-801-15DDiscontinued by firm2026-08-17

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A074747-001TIMOLOL MALEATETIMOLOL MALEATEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT11997-03-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A074747-001AT1

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A074747-001TIMOLOL MALEATEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT11997-03-25caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A074747-001TIMOLOL MALEATEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT11997-03-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074747-001TIMOLOL MALEATEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT11997-03-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08A074747-001TIMOLOL MALEATEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT11997-03-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074747-001TIMOLOL MALEATEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT11997-03-25fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074747-001TIMOLOL MALEATEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT11997-03-25b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074747-001TIMOLOL MALEATEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT11997-03-2503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074747-001TIMOLOL MALEATEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT11997-03-252680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074747-001TIMOLOL MALEATEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT11997-03-255bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074747-001TIMOLOL MALEATEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT11997-03-25d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074747-001TIMOLOL MALEATEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT11997-03-25d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074747-001TIMOLOL MALEATEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT11997-03-2579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074747-001TIMOLOL MALEATEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT11997-03-25301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074747-001TIMOLOL MALEATEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT11997-03-251e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074747-001TIMOLOL MALEATEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT11997-03-258072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074747-001TIMOLOL MALEATEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT11997-03-255c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A074747-001TIMOLOL MALEATEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT11997-03-255d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A074747-001TIMOLOL MALEATEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT11997-03-254b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A074747-001TIMOLOL MALEATEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT11997-03-2574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A074747-001TIMOLOL MALEATEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT11997-03-25bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A074747-001TIMOLOL MALEATEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT11997-03-25782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A074747-001TIMOLOL MALEATEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT11997-03-2587673890dc5c…
2021-03-12 10:30 UTC2021-03A074747-001TIMOLOL MALEATEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT11997-03-255aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A074747-001TIMOLOL MALEATEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT11997-03-258869cabd3fbd…
2020-11-12 02:37 UTC2020-11A074747-001TIMOLOL MALEATEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT11997-03-25c0c555d07b60…
2019-12-14 00:12 UTC2019-12A074747-001TIMOLOL MALEATEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT11997-03-253f01610625f2…
2019-09-15 20:21 UTC2019-09A074747-001TIMOLOL MALEATEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT11997-03-25b00525d2431f…
2019-07-19 19:46 UTC2019-07A074747-001TIMOLOL MALEATEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT11997-03-25ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A074747-001TIMOLOL MALEATEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT11997-03-256a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A074747-001TIMOLOL MALEATEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT11997-03-251c564ffb4f44…
2023-12-20 04:57 UTC2023-12A074747-001TIMOLOL MALEATEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT11997-03-25ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A074747-001TIMOLOL MALEATEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT11997-03-25a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A074747-001TIMOLOL MALEATEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT11997-03-259b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A074747-001TIMOLOL MALEATEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT11997-03-25a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A074747-001TIMOLOL MALEATEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT11997-03-253f0d92c62455…
2023-05-13 08:27 UTC2023-05A074747-001TIMOLOL MALEATEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT11997-03-25053a50430f4f…
2023-01-26 05:58 UTC2023-01A074747-001TIMOLOL MALEATEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT11997-03-253bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A074747-001TIMOLOL MALEATEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT11997-03-253a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A074747-001TIMOLOL MALEATEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT11997-03-25f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A074747-001TIMOLOL MALEATEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT11997-03-25e64feba35796…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A074747-001AT11caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A074747-001AT11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074747-001AT1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A074747-001AT116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074747-001AT11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074747-001AT11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074747-001AT1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074747-001AT112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074747-001AT115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074747-001AT11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074747-001AT11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074747-001AT1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074747-001AT11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074747-001AT111e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074747-001AT118072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074747-001AT115c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A074747-001AT115d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A074747-001AT114b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A074747-001AT1174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A074747-001AT11bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A074747-001AT11782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A074747-001AT1187673890dc5c…
2021-03-12 10:30 UTC2021-03A074747-001AT115aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A074747-001AT118869cabd3fbd…
2020-11-12 02:37 UTC2020-11A074747-001AT11c0c555d07b60…
2019-12-14 00:12 UTC2019-12A074747-001AT113f01610625f2…
2019-09-15 20:21 UTC2019-09A074747-001AT11b00525d2431f…
2019-07-19 19:46 UTC2019-07A074747-001AT11ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A074747-001AT116a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A074747-001AT111c564ffb4f44…
2023-12-20 04:57 UTC2023-12A074747-001AT11ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A074747-001AT11a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A074747-001AT119b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A074747-001AT11a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A074747-001AT113f0d92c62455…
2023-05-13 08:27 UTC2023-05A074747-001AT11053a50430f4f…
2023-01-26 05:58 UTC2023-01A074747-001AT113bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A074747-001AT113a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A074747-001AT11f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A074747-001AT11e64feba35796…

Additional Listing Data#

Finished product
Yes
Brand name base
TIMOLOL MALEATE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TIMOLOL MALEATE5 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
P8Y54F701RInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1923428Internal RxNorm lookup
1992303Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
e16c33fd-aa86-49ad-a767-c79ade4a62c7Available on FDA.report

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
273981e4-09e7-45cc-967c-554f628ededfProduct name320230627
97dad5a2-c524-a7b5-dede-82edefe9ce62Product name720220929
d11e749b-f93e-0ce3-ceda-28fe03d8081dProduct name220190731

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60758-801-05TIMOLOL MALEATE5 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS516
60758-801-05TIMOLOL MALEATE1 in 1 CARTONSOLUTION/ DROPS116
60758-801-10TIMOLOL MALEATE1 in 1 CARTONSOLUTION/ DROPS116
60758-801-10TIMOLOL MALEATE10 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS1016
60758-801-15TIMOLOL MALEATE1 in 1 CARTONSOLUTION/ DROPS116
60758-801-15TIMOLOL MALEATE15 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS1516

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60758-801-05ML - Milliliter60758-80163c3071b-7a27-4833-89e2-f56bdf6c118412012-07-24
60758-801-10ML - Milliliter60758-801208b0be4-87f2-4f97-beb8-1e5793c6b54312012-07-24
60758-801-15ML - Milliliter60758-801185db444-b1dd-46c8-8e1f-7079e042ac3f12012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60758-801TIMOLOL MALEATE SOLUTION/ DROPS [PACIFIC PHARMA, INC.]15Current NDC, Legacy NDC, 6 package rows20240404_e16c33fd-aa86-49ad-a767-c79ade4a62c7.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TIMOLOL MALEATETIMOLOL MALEATEA-S Medication Solutions1ffd9ed1-8ab4-4036-bbc6-dcf58e6592482024-06-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074747
application number: ANDA074747
TIMOLOL MALEATETIMOLOL MALEATEPacific Pharma, Inc.e16c33fd-aa86-49ad-a767-c79ade4a62c72024-03-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074747
application number: ANDA074747
ndc (product): 60758-801

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1992303timolol 0.5 % 12HR Ophthalmic SolutionPSNe16c33fd-aa86-49ad-a767-c79ade4a62c716
1923428timolol maleate 0.25 % Ophthalmic SolutionPSNe16c33fd-aa86-49ad-a767-c79ade4a62c716
199230312 HR timolol 5 MG/ML Ophthalmic SolutionSCDe16c33fd-aa86-49ad-a767-c79ade4a62c716
1923428timolol 2.5 MG/ML Ophthalmic SolutionSCDe16c33fd-aa86-49ad-a767-c79ade4a62c716
1923428timolol 0.25 % Ophthalmic SolutionSYe16c33fd-aa86-49ad-a767-c79ade4a62c716
1992303timolol 0.5 % (as timolol maleate 6.8 MG/ML) 12 HR Ophthalmic SolutionSYe16c33fd-aa86-49ad-a767-c79ade4a62c716
1992303timolol 0.5 % 12 HR Ophthalmic SolutionSYe16c33fd-aa86-49ad-a767-c79ade4a62c716
1923428timolol 2.5 MG/ML (as timolol maleate 3.4 MG/ML) Ophthalmic SolutionSYe16c33fd-aa86-49ad-a767-c79ade4a62c716
1992303timolol 0.5 % 12HR Ophthalmic SolutionPSN1ffd9ed1-8ab4-4036-bbc6-dcf58e6592487
199230312 HR timolol 5 MG/ML Ophthalmic SolutionSCD1ffd9ed1-8ab4-4036-bbc6-dcf58e6592487
1992303timolol 0.5 % (as timolol maleate 6.8 MG/ML) 12 HR Ophthalmic SolutionSY1ffd9ed1-8ab4-4036-bbc6-dcf58e6592487
1992303timolol 0.5 % 12 HR Ophthalmic SolutionSY1ffd9ed1-8ab4-4036-bbc6-dcf58e6592487

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
60758-801-05607580801051 BOTTLE, DROPPER in 1 CARTON (60758-801-05) / 5 mL in 1 BOTTLE, DROPPER1997-05-200000-00-00NoNoCurrent
60758-801-10607580801101 BOTTLE, DROPPER in 1 CARTON (60758-801-10) / 10 mL in 1 BOTTLE, DROPPER1997-05-200000-00-00NoNoCurrent
60758-801-15607580801151 in 1 CARTONHistorical