FDA.reportPublic FDA data

Timolol Maleate

Product NDC
82260-813
11-digit product format
822600813
Labeler code
82260
Product ID
82260-813_2f8c4356-d1fe-ff3f-e063-6394a90a2832
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Timolol Maleate
Dosage form
SOLUTION
Route
OPHTHALMIC
Labeler
Bausch & Lomb Americas Inc.
Application
NDA018086
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2020-06-01
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
Rxcui1923428, 1992303

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82260-813-05Timolol Maleate5 mL in 1 BOTTLE, DISPENSINGSOLUTION55
82260-813-05Timolol Maleate1 in 1 CARTONSOLUTION15
82260-813-10Timolol Maleate1 in 1 CARTONSOLUTION15
82260-813-10Timolol Maleate10 mL in 1 BOTTLE, DISPENSINGSOLUTION105

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82260-813-05ML - Milliliter82260-813bd3bb024-35fb-4cfa-982a-5c0e648e426512024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82260-813TIMOLOL MALEATE SOLUTION [BAUSCH & LOMB AMERICAS INC.]5Current NDC, Legacy NDC, 4 package rows20250306_9c14ca2d-80f3-48ef-b99a-beafaa728a24.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1992303timolol 0.5 % 12HR Ophthalmic SolutionPSN9c14ca2d-80f3-48ef-b99a-beafaa728a245
1923428timolol maleate 0.25 % Ophthalmic SolutionPSN9c14ca2d-80f3-48ef-b99a-beafaa728a245
199230312 HR timolol 5 MG/ML Ophthalmic SolutionSCD9c14ca2d-80f3-48ef-b99a-beafaa728a245
1923428timolol 2.5 MG/ML Ophthalmic SolutionSCD9c14ca2d-80f3-48ef-b99a-beafaa728a245
1923428timolol 0.25 % Ophthalmic SolutionSY9c14ca2d-80f3-48ef-b99a-beafaa728a245
1992303timolol 0.5 % (as timolol maleate 6.8 MG/ML) 12 HR Ophthalmic SolutionSY9c14ca2d-80f3-48ef-b99a-beafaa728a245
1992303timolol 0.5 % 12 HR Ophthalmic SolutionSY9c14ca2d-80f3-48ef-b99a-beafaa728a245
1923428timolol 2.5 MG/ML (as timolol maleate 3.4 MG/ML) Ophthalmic SolutionSY9c14ca2d-80f3-48ef-b99a-beafaa728a245

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
82260-813-05822600813051 BOTTLE, DISPENSING in 1 CARTON (82260-813-05) / 5 mL in 1 BOTTLE, DISPENSING2020-06-010000-00-00NoNoCurrent
82260-813-10822600813101 BOTTLE, DISPENSING in 1 CARTON (82260-813-10) / 10 mL in 1 BOTTLE, DISPENSING2020-06-010000-00-00NoNoCurrent