Timoptic-XE

Product NDC
24208-814
11-digit product format
242080814
Labeler code
24208
Product ID
24208-814_cb6890c5-7788-453b-910d-10c2bee17d04
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Timolol Maleate
Dosage form
SOLUTION
Route
OPHTHALMIC
Labeler
Bausch & Lomb Incorporated
Application
NDA020330
Marketing category
NDA
Marketing start
2016-05-31
Substance
TIMOLOL MALEATE
Active strength
2.5 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
Timoptic-XE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TIMOLOL MALEATE2.5 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiP8Y54F701R
Rxcui313407, 313408, 861420, 861422

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
24208-814-25Timoptic-XE1 in 1 CARTONSOLUTION111
24208-814-25Timoptic-XE5 mL in 1 BOTTLE, DISPENSINGSOLUTION511

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
24208-814-25ML - Milliliter24208-814d5ef76c1-3819-4efb-b2a8-a58ec8f7c85212018-03-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24208-814TIMOPTIC-XE (TIMOLOL MALEATE) SOLUTION [BAUSCH & LOMB INCORPORATED]11Current NDC, Legacy NDC, 2 package rows20220521_a4d03de7-06b7-4cfc-9d1b-616969df209c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313407timolol maleate 0.25 % Ophthalmic Gel Forming SolutionPSNa4d03de7-06b7-4cfc-9d1b-616969df209c11
313408timolol maleate 0.5 % Ophthalmic Gel Forming SolutionPSNa4d03de7-06b7-4cfc-9d1b-616969df209c11
861420Timoptic-XE 0.25 % Ophthalmic Gel Forming SolutionPSNa4d03de7-06b7-4cfc-9d1b-616969df209c11
861422Timoptic-XE 0.5 % Ophthalmic Gel Forming SolutionPSNa4d03de7-06b7-4cfc-9d1b-616969df209c11
861420timolol 0.0025 MG/MG Ophthalmic Gel [Timoptic]SBDa4d03de7-06b7-4cfc-9d1b-616969df209c11
861422timolol 0.005 MG/MG Ophthalmic Gel [Timoptic]SBDa4d03de7-06b7-4cfc-9d1b-616969df209c11
313407timolol 0.0025 MG/MG Ophthalmic GelSCDa4d03de7-06b7-4cfc-9d1b-616969df209c11
313408timolol 0.005 MG/MG Ophthalmic GelSCDa4d03de7-06b7-4cfc-9d1b-616969df209c11
313407timolol 0.25 % Ophthalmic GelSYa4d03de7-06b7-4cfc-9d1b-616969df209c11
313407timolol 0.25 % Ophthalmic Gel Forming SolutionSYa4d03de7-06b7-4cfc-9d1b-616969df209c11
313408timolol 0.5 % (as timolol maleate 6.8 MG/ML) Ophthalmic GelSYa4d03de7-06b7-4cfc-9d1b-616969df209c11
313408timolol 0.5 % Gel Forming Ophthalmic SolutionSYa4d03de7-06b7-4cfc-9d1b-616969df209c11
861420Timoptic 0.0025 MG/MG Ophthalmic GelSYa4d03de7-06b7-4cfc-9d1b-616969df209c11
861422Timoptic 0.005 MG/MG Ophthalmic GelSYa4d03de7-06b7-4cfc-9d1b-616969df209c11
861420Timoptic-XE 0.0025 MG/MG Ophthalmic GelSYa4d03de7-06b7-4cfc-9d1b-616969df209c11
861422Timoptic-XE 0.005 MG/MG Ophthalmic GelSYa4d03de7-06b7-4cfc-9d1b-616969df209c11
861420Timoptic-XE 0.25 % Gel Forming SolutionSYa4d03de7-06b7-4cfc-9d1b-616969df209c11
861422Timoptic-XE 0.5 % Gel Forming SolutionSYa4d03de7-06b7-4cfc-9d1b-616969df209c11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
24208-814-25242080814251 BOTTLE, DISPENSING in 1 CARTON (24208-814-25) / 5 mL in 1 BOTTLE, DISPENSING2016-05-310000-00-00NoNoCurrent