Timolol Maleate

Product NDC
82260-819
11-digit product format
822600819
Labeler code
82260
Product ID
82260-819_31420e86-ee3b-e6b1-e063-6394a90aefc7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Timolol Maleate
Dosage form
SOLUTION
Route
OPHTHALMIC
Labeler
Bausch & Lomb Americas Inc.
Application
NDA020330
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2018-02-14
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
Rxcui313407, 313408

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6c0c444-a6ba-2fb5-a7bc-7f0443fa5791Product name420251208
77dc03a4-fbfc-e6a3-fe95-285bbae40d75Product name220250814
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82260-819-05Timolol Maleate5 mL in 1 BOTTLE, DISPENSINGSOLUTION54
82260-819-05Timolol Maleate1 in 1 CARTONSOLUTION14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82260-819-05ML - Milliliter82260-81914a07d5a-8730-466e-8e95-852896e5190a12024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82260-819TIMOLOL MALEATE SOLUTION [BAUSCH & LOMB AMERICAS INC.]4Current NDC, Legacy NDC, 2 package rows20250328_581f80f7-4419-49e2-867d-40443c75409f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313407timolol maleate 0.25 % Ophthalmic Gel Forming SolutionPSN581f80f7-4419-49e2-867d-40443c75409f4
313408timolol maleate 0.5 % Ophthalmic Gel Forming SolutionPSN581f80f7-4419-49e2-867d-40443c75409f4
313407timolol 0.0025 MG/MG Ophthalmic GelSCD581f80f7-4419-49e2-867d-40443c75409f4
313408timolol 0.005 MG/MG Ophthalmic GelSCD581f80f7-4419-49e2-867d-40443c75409f4
313407timolol 0.25 % Ophthalmic GelSY581f80f7-4419-49e2-867d-40443c75409f4
313407timolol 0.25 % Ophthalmic Gel Forming SolutionSY581f80f7-4419-49e2-867d-40443c75409f4
313408timolol 0.5 % (as timolol maleate 6.8 MG/ML) Ophthalmic GelSY581f80f7-4419-49e2-867d-40443c75409f4
313408timolol 0.5 % Gel Forming Ophthalmic SolutionSY581f80f7-4419-49e2-867d-40443c75409f4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
82260-819-05822600819051 BOTTLE, DISPENSING in 1 CARTON (82260-819-05) / 5 mL in 1 BOTTLE, DISPENSING2018-02-140000-00-00NoNoCurrent