FDA.reportPublic FDA data

Timolol Maleate

Product NDC
73152-029
11-digit product format
731520029
Labeler code
73152
Product ID
73152-029_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
5 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

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
73152-029-012026-01-29C16284748780-149896155-a9f3-586f-e063-e6dba90add90Timolol Maleate

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73152-029-01Timolol Maleate100 in 1 BOTTLETABLET1005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
73152-029-01EA - Each73152-029478ce5a3-cce2-4fdd-86d5-cebfd5117dd512022-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73152-029TIMOLOL MALEATE TABLET [ATHEM LLC]5Legacy NDC, 1 package rows20220401_d591352a-09d8-2fdc-e053-2a95a90ad8a5.zip

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
73152-029-0173152002901100 TABLET in 1 BOTTLE (73152-029-01) 100 tablet2022-01-140000-00-00NoNoCurrent