TIMOLOL MALEATE

Product NDC
50090-5091
11-digit product format
500905091
Labeler code
50090
Product ID
50090-5091_2d97c6d5-4075-4937-9452-47391965bf84
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
timolol maleate
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
A-S Medication Solutions
Application
ANDA077259
Marketing category
ANDA
Marketing start
2014-12-15
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
50090-5091-02023-01-30C16284748780-1f386c64a-48f0-0266-e053-dadaa90a7c1aSTERILE OPHTHALMIC SOLUTION TIMOLOL MALEATEOPHTHALMIC SOLUTIONUSP 0.25% AND 0.5%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5091-0TIMOLOL MALEATE1 in 1 CARTONSOLUTION/ DROPS12
50090-5091-0TIMOLOL MALEATE5 mL in 1 BOTTLESOLUTION/ DROPS52

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5091TIMOLOL MALEATE SOLUTION/ DROPS [A-S MEDICATION SOLUTIONS]2Legacy NDC, 2 package rows20200822_9fd81371-caca-44c3-bd1d-d095b26a0241.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1992303timolol 0.5 % 12HR Ophthalmic SolutionPSN9fd81371-caca-44c3-bd1d-d095b26a02412
199230312 HR timolol 5 MG/ML Ophthalmic SolutionSCD9fd81371-caca-44c3-bd1d-d095b26a02412
1992303timolol 0.5 % (as timolol maleate 6.8 MG/ML) 12 HR Ophthalmic SolutionSY9fd81371-caca-44c3-bd1d-d095b26a02412
1992303timolol 0.5 % 12 HR Ophthalmic SolutionSY9fd81371-caca-44c3-bd1d-d095b26a02412

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-5091-0500905091001 BOTTLE in 1 CARTON (50090-5091-0) > 5 mL in 1 BOTTLE1 bottle2020-06-300000-00-00NoNoCurrent