FDA.reportPublic FDA data

Timolol Maleate

Product NDC
68682-045
11-digit product format
686820045
Labeler code
68682
Product ID
68682-045_4fe86cd0-e1e4-e99c-e063-6294a90a2f03
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Timolol Maleate
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Oceanside Pharmaceuticals
Application
NDA021516
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2018-05-30
Marketing end
2026-08-31
Substance
TIMOLOL MALEATE
Active strength
5 mg/mL
Pharmacologic classes
Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Timolol Maleate

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TIMOLOL MALEATE5 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiP8Y54F701R
Rxcui1992299

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
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
03f77cb2-b4ad-3c11-8781-787b5ece4291Product name320240507
273981e4-09e7-45cc-967c-554f628ededfProduct name320230627
97dad5a2-c524-a7b5-dede-82edefe9ce62Product name720220929
d11e749b-f93e-0ce3-ceda-28fe03d8081dProduct name220190731
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68682-045-25Timolol Maleate2.5 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS2.53
68682-045-25Timolol Maleate1 in 1 CARTONSOLUTION/ DROPS13
68682-045-50Timolol Maleate1 in 1 CARTONSOLUTION/ DROPS13
68682-045-50Timolol Maleate5 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS53

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68682-045-25ML - Milliliter68682-045c4a3eabc-ca78-44af-adba-ffbf7bebf92112018-07-03
68682-045-50ML - Milliliter68682-0457c0dc24a-0aee-40a0-9f3d-2d580fef468612018-07-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68682-045TIMOLOL MALEATE SOLUTION/ DROPS [OCEANSIDE PHARMACEUTICALS]2Current NDC, Legacy NDC, 4 package rows20200124_3c20b537-88c6-4ec7-a359-e0ba67afe431.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1992299timolol 0.5 % 24HR Ophthalmic SolutionPSN3c20b537-88c6-4ec7-a359-e0ba67afe4313
199229924 HR timolol 5 MG/ML Ophthalmic SolutionSCD3c20b537-88c6-4ec7-a359-e0ba67afe4313
1992299timolol 0.5 % (as timolol maleate 6.8 MG/ML) 24 HR Ophthalmic SolutionSY3c20b537-88c6-4ec7-a359-e0ba67afe4313
1992299timolol 0.5 % 24 HR Ophthalmic SolutionSY3c20b537-88c6-4ec7-a359-e0ba67afe4313

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68682-045-25686820045251 BOTTLE, DROPPER in 1 CARTON (68682-045-25) / 2.5 mL in 1 BOTTLE, DROPPER2018-05-302026-08-31NoNoCurrent
68682-045-50686820045501 BOTTLE, DROPPER in 1 CARTON (68682-045-50) > 5 mL in 1 BOTTLE, DROPPER2018-05-300000-00-00NoNoCurrent