FDA.reportPublic FDA data

Timolol Maleate

Product NDC
42571-403
11-digit product format
425710403
Labeler code
42571
Product ID
42571-403_238fd036-1868-da83-e063-6394a90a0596
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Timolol Maleate Ophthalmic
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Micro Labs Limited
Application
ANDA217343
Marketing category
ANDA
Marketing start
2023-08-01
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
Timolol Maleate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TIMOLOL MALEATE2.5 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
42571-403-21Timolol Maleate5 mL in 1 BOTTLESOLUTION/ DROPS54
42571-403-88Timolol Maleate10 mL in 1 BOTTLESOLUTION/ DROPS104

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42571-403TIMOLOL MALEATE (TIMOLOL MALEATE OPHTHALMIC) SOLUTION/ DROPS [MICRO LABS LIMITED]4Current NDC, 2 package rows20241004_6c9f3971-8c07-4d3a-915d-76438baa2a0b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1992303timolol 0.5 % 12HR Ophthalmic SolutionPSN6c9f3971-8c07-4d3a-915d-76438baa2a0b4
1923428timolol maleate 0.25 % Ophthalmic SolutionPSN6c9f3971-8c07-4d3a-915d-76438baa2a0b4
199230312 HR timolol 5 MG/ML Ophthalmic SolutionSCD6c9f3971-8c07-4d3a-915d-76438baa2a0b4
1923428timolol 2.5 MG/ML Ophthalmic SolutionSCD6c9f3971-8c07-4d3a-915d-76438baa2a0b4
1923428timolol 0.25 % Ophthalmic SolutionSY6c9f3971-8c07-4d3a-915d-76438baa2a0b4
1992303timolol 0.5 % (as timolol maleate 6.8 MG/ML) 12 HR Ophthalmic SolutionSY6c9f3971-8c07-4d3a-915d-76438baa2a0b4
1992303timolol 0.5 % 12 HR Ophthalmic SolutionSY6c9f3971-8c07-4d3a-915d-76438baa2a0b4
1923428timolol 2.5 MG/ML (as timolol maleate 3.4 MG/ML) Ophthalmic SolutionSY6c9f3971-8c07-4d3a-915d-76438baa2a0b4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
42571-403-21425710403215 mL in 1 BOTTLE (42571-403-21) 5 ml2023-08-01NoNoCurrent
42571-403-884257104038810 mL in 1 BOTTLE (42571-403-88) 10 ml2023-08-01NoNoCurrent