FDA.reportPublic FDA data

TIMOLOL MALEATE

Product NDC
50090-5769
11-digit product format
500905769
Labeler code
50090
Product ID
50090-5769_d735453e-9319-44c7-971e-518e89e91c1a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
timolol maleate
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
A-S Medication Solutions
Application
ANDA074747
Marketing category
ANDA
Marketing start
1997-05-20
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
TIMOLOL MALEATE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TIMOLOL MALEATE5 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiP8Y54F701R
Rxcui1992303

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
50090-5769-02023-02-07C16284748780-1f386c649-f640-0266-e053-dadaa90a7c1aTIMOLOL MALEATE ophthalmic solution , USP 0.25% and 0.5% sterile
50090-5769-02023-01-30C16284748780-1f386c649-f640-0266-e053-dadaa90a7c1aTIMOLOL MALEATE ophthalmic solution , USP 0.25% and 0.5% sterile

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5769-0TIMOLOL MALEATE10 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS107
50090-5769-0TIMOLOL MALEATE1 in 1 CARTONSOLUTION/ DROPS17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5769-0ML - Milliliter50090-5769b39fe5c4-3793-41e0-a06c-cdf1461d217d12024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5769TIMOLOL MALEATE SOLUTION/ DROPS [A-S MEDICATION SOLUTIONS]7Current NDC, Legacy NDC, 2 package rows20240604_1ffd9ed1-8ab4-4036-bbc6-dcf58e659248.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1992303timolol 0.5 % 12HR Ophthalmic SolutionPSN1ffd9ed1-8ab4-4036-bbc6-dcf58e6592487
199230312 HR timolol 5 MG/ML Ophthalmic SolutionSCD1ffd9ed1-8ab4-4036-bbc6-dcf58e6592487
1992303timolol 0.5 % (as timolol maleate 6.8 MG/ML) 12 HR Ophthalmic SolutionSY1ffd9ed1-8ab4-4036-bbc6-dcf58e6592487
1992303timolol 0.5 % 12 HR Ophthalmic SolutionSY1ffd9ed1-8ab4-4036-bbc6-dcf58e6592487

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-5769-0500905769001 BOTTLE, DROPPER in 1 CARTON (50090-5769-0) / 10 mL in 1 BOTTLE, DROPPER2021-10-050000-00-00NoNoCurrent