TIMOLOL MALEATE

Product NDC
45865-121
11-digit product format
458650121
Labeler code
45865
Product ID
45865-121_b41b1b81-5d8d-48a9-e053-2a95a90a6ef6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
timolol maleate
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Medsource Pharmaceuticals
Application
ANDA077259
Marketing category
ANDA
Marketing start
2020-07-01
Marketing end
0000-00-00
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
2021-12-31
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
45865-121-012025-01-30C16284748780-12cef2736-9f5b-d83d-e063-dadaa90ab31fSTERILE OPHTHALMIC SOLUTION TIMOLOL MALEATEOPHTHALMIC SOLUTIONUSP 0.5%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45865-121-01TIMOLOL MALEATE5 mL in 1 BOTTLESOLUTION/ DROPS51
45865-121-01TIMOLOL MALEATE1 in 1 CARTONSOLUTION/ DROPS11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45865-121TIMOLOL MALEATE SOLUTION/ DROPS [MEDSOURCE PHARMACEUTICALS]1Legacy NDC, 2 package rows20201117_b41b1b81-5d8c-48a9-e053-2a95a90a6ef6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1992303timolol 0.5 % 12HR Ophthalmic SolutionPSNb41b1b81-5d8c-48a9-e053-2a95a90a6ef61
199230312 HR timolol 5 MG/ML Ophthalmic SolutionSCDb41b1b81-5d8c-48a9-e053-2a95a90a6ef61
1992303timolol 0.5 % (as timolol maleate 6.8 MG/ML) 12 HR Ophthalmic SolutionSYb41b1b81-5d8c-48a9-e053-2a95a90a6ef61
1992303timolol 0.5 % 12 HR Ophthalmic SolutionSYb41b1b81-5d8c-48a9-e053-2a95a90a6ef61

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45865-121-01458650121011 BOTTLE in 1 CARTON (45865-121-01) > 5 mL in 1 BOTTLE1 bottle2020-07-010000-00-00NoNoCurrent