Timolol Maleate

Product NDC
73152-030
11-digit product format
731520030
Labeler code
73152
Product ID
73152-030_d9bb4169-103d-dd54-e053-2995a90a1df7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Timolol Maleate
Dosage form
TABLET
Route
ORAL
Labeler
Athem LLC
Application
ANDA207556
Marketing category
ANDA
Marketing start
2022-01-14
Marketing end
0000-00-00
Substance
TIMOLOL MALEATE
Active strength
10 mg/1
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct73152-030IInactivated by FDA2026-08-11
excluded packagepackage73152-03073152-030-01IInactivated by FDA2026-08-11

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A207556-001TIMOLOL MALEATETIMOLOL MALEATE5MGTABLET / ORAL2019-05-02
A207556-002TIMOLOL MALEATETIMOLOL MALEATE10MGTABLET / ORALAB2019-05-02
A207556-003TIMOLOL MALEATETIMOLOL MALEATE20MGTABLET / ORALRS2019-05-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A207556-002AB

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 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A207556-001TIMOLOL MALEATE5MGTABLET / ORALAB2019-05-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207556-002TIMOLOL MALEATE10MGTABLET / ORALAB2019-05-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207556-003TIMOLOL MALEATE20MGTABLET / ORALAB2019-05-02011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207556-001TIMOLOL MALEATE5MGTABLET / ORALAB2019-05-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207556-002TIMOLOL MALEATE10MGTABLET / ORALAB2019-05-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207556-003TIMOLOL MALEATE20MGTABLET / ORALAB2019-05-0231067a03dcf5…
2025-08-23 18:47 UTC2025-08A207556-001TIMOLOL MALEATE5MGTABLET / ORALAB2019-05-026a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207556-002TIMOLOL MALEATE10MGTABLET / ORALAB2019-05-026a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207556-003TIMOLOL MALEATE20MGTABLET / ORALAB2019-05-026a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207556-001TIMOLOL MALEATE5MGTABLET / ORALAB2019-05-02fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207556-002TIMOLOL MALEATE10MGTABLET / ORALAB2019-05-02fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207556-003TIMOLOL MALEATE20MGTABLET / ORALAB2019-05-02fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207556-001TIMOLOL MALEATE5MGTABLET / ORALAB2019-05-02b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207556-002TIMOLOL MALEATE10MGTABLET / ORALAB2019-05-02b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207556-003TIMOLOL MALEATE20MGTABLET / ORALAB2019-05-02b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207556-001TIMOLOL MALEATE5MGTABLET / ORALAB2019-05-0203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207556-002TIMOLOL MALEATE10MGTABLET / ORALAB2019-05-0203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207556-003TIMOLOL MALEATE20MGTABLET / ORALAB2019-05-0203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207556-001TIMOLOL MALEATE5MGTABLET / ORALAB2019-05-022680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207556-002TIMOLOL MALEATE10MGTABLET / ORALAB2019-05-022680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207556-003TIMOLOL MALEATE20MGTABLET / ORALAB2019-05-022680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207556-001TIMOLOL MALEATE5MGTABLET / ORALAB2019-05-025bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207556-002TIMOLOL MALEATE10MGTABLET / ORALAB2019-05-025bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207556-003TIMOLOL MALEATE20MGTABLET / ORALAB2019-05-025bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207556-001TIMOLOL MALEATE5MGTABLET / ORALAB2019-05-02d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207556-002TIMOLOL MALEATE10MGTABLET / ORALAB2019-05-02d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207556-003TIMOLOL MALEATE20MGTABLET / ORALAB2019-05-02d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207556-001TIMOLOL MALEATE5MGTABLET / ORALAB2019-05-02d06236e962d9…
2024-10-29 15:01 UTC2024-10A207556-002TIMOLOL MALEATE10MGTABLET / ORALAB2019-05-02d06236e962d9…
2024-10-29 15:01 UTC2024-10A207556-003TIMOLOL MALEATE20MGTABLET / ORALAB2019-05-02d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207556-001TIMOLOL MALEATE5MGTABLET / ORALAB2019-05-0279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207556-002TIMOLOL MALEATE10MGTABLET / ORALAB2019-05-0279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207556-003TIMOLOL MALEATE20MGTABLET / ORALAB2019-05-0279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207556-001TIMOLOL MALEATE5MGTABLET / ORALAB2019-05-02301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207556-002TIMOLOL MALEATE10MGTABLET / ORALAB2019-05-02301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207556-003TIMOLOL MALEATE20MGTABLET / ORALAB2019-05-02301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207556-001TIMOLOL MALEATE5MGTABLET / ORALAB2019-05-021e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207556-002TIMOLOL MALEATE10MGTABLET / ORALAB2019-05-021e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207556-003TIMOLOL MALEATE20MGTABLET / ORALAB2019-05-021e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207556-001TIMOLOL MALEATE5MGTABLET / ORALAB2019-05-028072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 121 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A207556-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207556-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207556-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207556-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207556-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207556-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A207556-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207556-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207556-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207556-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207556-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207556-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207556-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207556-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207556-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207556-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207556-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207556-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207556-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207556-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207556-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207556-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207556-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207556-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207556-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207556-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207556-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207556-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A207556-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A207556-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207556-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207556-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207556-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207556-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207556-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207556-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207556-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207556-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207556-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207556-001AB18072bd15b7f6…

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73152-030-012026-01-29C16284748780-149896155-a9f3-586f-e063-e6dba90add90Timolol Maleate

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73152-030-01Timolol Maleate100 in 1 BOTTLETABLET1005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
73152-030-01EA - Each73152-03034c59200-1a79-403e-b7fc-6b7ab11cbeea12022-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73152-030TIMOLOL MALEATE TABLET [ATHEM LLC]5Legacy NDC, 1 package rows20220401_d591352a-09d8-2fdc-e053-2a95a90ad8a5.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.0bc40b2c-65eb-4095-87e6-4752d5b19a3a2024-06-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207556
application number: ANDA207556

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198284timolol maleate 10 MG Oral TabletPSNd591352a-09d8-2fdc-e053-2a95a90ad8a55
198285timolol maleate 20 MG Oral TabletPSNd591352a-09d8-2fdc-e053-2a95a90ad8a55
198286timolol maleate 5 MG Oral TabletPSNd591352a-09d8-2fdc-e053-2a95a90ad8a55
198284timolol 10 MG Oral TabletSCDd591352a-09d8-2fdc-e053-2a95a90ad8a55
198285timolol 20 MG Oral TabletSCDd591352a-09d8-2fdc-e053-2a95a90ad8a55
198286timolol 5 MG Oral TabletSCDd591352a-09d8-2fdc-e053-2a95a90ad8a55
198284timolol 10 MG (as maleate) Oral TabletSYd591352a-09d8-2fdc-e053-2a95a90ad8a55
198285timolol 20 MG (as maleate) Oral TabletSYd591352a-09d8-2fdc-e053-2a95a90ad8a55
198286timolol 5 MG (as maleate) Oral TabletSYd591352a-09d8-2fdc-e053-2a95a90ad8a55

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
73152-030-0173152003001100 TABLET in 1 BOTTLE (73152-030-01) 100 tablet2022-01-140000-00-00NoNoCurrent