FDA.reportPublic FDA data

Timolol Maleate

Product NDC
17478-189
Requested package NDC
17478-189-24
11-digit product format
174780189
Labeler code
17478
Product ID
17478-189_3f1e6c20-b5aa-42fd-b31c-b2c9547e0991
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Timolol
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Akorn
Application
ANDA212291
Marketing category
ANDA
Marketing start
2020-09-11
Marketing end
0000-00-00
Substance
TIMOLOL
Active strength
5 mg/mL
Pharmacologic classes
Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

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 packagepackage17478-18917478-189-24IInactivated by FDA2026-08-11

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 · 15 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…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…

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

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
A212291-001TIMOLOL MALEATETIMOLOL MALEATEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT32020-09-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A212291-001AT3

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A212291-001TIMOLOL MALEATEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT32020-09-11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212291-001TIMOLOL MALEATEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT32020-09-1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A212291-001TIMOLOL MALEATEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT32020-09-116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212291-001TIMOLOL MALEATEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT32020-09-11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212291-001TIMOLOL MALEATEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT32020-09-11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212291-001TIMOLOL MALEATEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT32020-09-1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212291-001TIMOLOL MALEATEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT32020-09-112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212291-001TIMOLOL MALEATEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT32020-09-115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212291-001TIMOLOL MALEATEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT32020-09-11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A212291-001TIMOLOL MALEATEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT32020-09-11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212291-001TIMOLOL MALEATEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT32020-09-1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212291-001TIMOLOL MALEATEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT32020-09-11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212291-001TIMOLOL MALEATEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT32020-09-111e350fbaab3a…
2024-05-31 18:47 UTC2024-05A212291-001TIMOLOL MALEATEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT32020-09-118072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A212291-001TIMOLOL MALEATEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT32020-09-115c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A212291-001TIMOLOL MALEATEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT32020-09-115d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A212291-001TIMOLOL MALEATEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT32020-09-114b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A212291-001TIMOLOL MALEATEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT32020-09-11bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A212291-001TIMOLOL MALEATEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT32020-09-11782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A212291-001TIMOLOL MALEATEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT32020-09-1187673890dc5c…
2021-03-12 10:30 UTC2021-03A212291-001TIMOLOL MALEATEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT32020-09-115aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A212291-001TIMOLOL MALEATEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT32020-09-118869cabd3fbd…
2020-11-12 02:37 UTC2020-11A212291-001TIMOLOL MALEATEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT32020-09-11c0c555d07b60…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A212291-001TIMOLOL MALEATEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT32020-09-116a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A212291-001TIMOLOL MALEATEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT32020-09-111c564ffb4f44…
2023-12-20 04:57 UTC2023-12A212291-001TIMOLOL MALEATEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT32020-09-11ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A212291-001TIMOLOL MALEATEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT32020-09-11a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A212291-001TIMOLOL MALEATEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT32020-09-119b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A212291-001TIMOLOL MALEATEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT32020-09-11a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A212291-001TIMOLOL MALEATEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT32020-09-113f0d92c62455…
2023-05-13 08:27 UTC2023-05A212291-001TIMOLOL MALEATEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT32020-09-11053a50430f4f…
2023-01-26 05:58 UTC2023-01A212291-001TIMOLOL MALEATEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT32020-09-113bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A212291-001TIMOLOL MALEATEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT32020-09-113a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A212291-001TIMOLOL MALEATEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT32020-09-11f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A212291-001TIMOLOL MALEATEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT32020-09-11e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A212291-001TIMOLOL MALEATEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT32020-09-11cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A212291-001TIMOLOL MALEATEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT32020-09-11a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A212291-001AT31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212291-001AT3131067a03dcf5…
2025-08-23 18:47 UTC2025-08A212291-001AT316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212291-001AT31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212291-001AT31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212291-001AT3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212291-001AT312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212291-001AT315bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212291-001AT31d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A212291-001AT31d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212291-001AT3179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212291-001AT31301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212291-001AT311e350fbaab3a…
2024-05-31 18:47 UTC2024-05A212291-001AT318072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A212291-001AT315c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A212291-001AT315d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A212291-001AT314b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A212291-001AT31bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A212291-001AT31782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A212291-001AT3187673890dc5c…
2021-03-12 10:30 UTC2021-03A212291-001AT315aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A212291-001AT318869cabd3fbd…
2020-11-12 02:37 UTC2020-11A212291-001AT31c0c555d07b60…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A212291-001AT316a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A212291-001AT311c564ffb4f44…
2023-12-20 04:57 UTC2023-12A212291-001AT31ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A212291-001AT31a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A212291-001AT319b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A212291-001AT31a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A212291-001AT313f0d92c62455…
2023-05-13 08:27 UTC2023-05A212291-001AT31053a50430f4f…
2023-01-26 05:58 UTC2023-01A212291-001AT313bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A212291-001AT313a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A212291-001AT31f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A212291-001AT31e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A212291-001AT31cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A212291-001AT31a50c72e98297…

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
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
03f77cb2-b4ad-3c11-8781-787b5ece4291Product name320240507
273981e4-09e7-45cc-967c-554f628ededfProduct name320230627
97dad5a2-c524-a7b5-dede-82edefe9ce62Product name720220929
d11e749b-f93e-0ce3-ceda-28fe03d8081dProduct name220190731
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
17478-189-242024-01-30C16284748780-11030e365-54cf-111a-e063-dadaa90a10e2Timolol Maleate Ophthalmic Solution USP, 0.5%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17478-189-24Timolol Maleate0.3 mL in 1 VIAL, SINGLE-DOSESOLUTION/ DROPS0.36
17478-189-24Timolol Maleate12 in 1 CARTONSOLUTION/ DROPS126

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17478-189TIMOLOL MALEATE (TIMOLOL) SOLUTION/ DROPS [AKORN]6Legacy NDC, 2 package rows20220919_b969bb47-6b4a-46ee-93cc-52faee4369c4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1922894timolol PF 0.5 % Ophthalmic SolutionPSNb969bb47-6b4a-46ee-93cc-52faee4369c46
1922894Preservative-Free timolol 5 MG/ML Ophthalmic SolutionSCDb969bb47-6b4a-46ee-93cc-52faee4369c46
1922894timolol PF 0.5 % Ophthalmic SolutionSYb969bb47-6b4a-46ee-93cc-52faee4369c46
1922894timolol PF 5 MG/ML (as timolol maleate 6.8 MG/ML) Ophthalmic SolutionSYb969bb47-6b4a-46ee-93cc-52faee4369c46

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
17478-189-241747801892412 VIAL, SINGLE-DOSE in 1 CARTON (17478-189-24) > .3 mL in 1 VIAL, SINGLE-DOSE2020-09-110000-00-00NoNoCurrent