FDA.reportPublic FDA data

Timolol Maleate Ophthalmic Gel Forming Solution, 0.25%

Product NDC
46708-545
11-digit product format
467080545
Labeler code
46708
Product ID
46708-545_9a5aab8f-59b9-4d73-82c4-dc5b8fa8119e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Timolol Maleate Ophthalmic Gel Forming Solution, 0.25%
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Alembic Pharmaceuticals Limited
Application
ANDA212942
Marketing category
ANDA
Marketing start
2020-11-22
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 Ophthalmic Gel Forming Solution, 0.25%
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

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
46708-545-05Timolol Maleate Ophthalmic Gel Forming Solution, 0.25%5 mL in 1 BOTTLESOLUTION/ DROPS51
46708-545-05Timolol Maleate Ophthalmic Gel Forming Solution, 0.25%1 in 1 CARTONSOLUTION/ DROPS11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46708-545TIMOLOL MALEATE OPHTHALMIC GEL FORMING SOLUTION, 0.25% SOLUTION/ DROPS TIMOLOL MALEATE OPHTHALMIC GEL FORMING SOLUTION, 0.5% SOLUTION/ DROPS [ALEMBIC PHARMACEUTICALS LIMITED]1Current NDC, 2 package rows20250427_9a5aab8f-59b9-4d73-82c4-dc5b8fa8119e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313407timolol maleate 0.25 % Ophthalmic Gel Forming SolutionPSN9a5aab8f-59b9-4d73-82c4-dc5b8fa8119e1
313408timolol maleate 0.5 % Ophthalmic Gel Forming SolutionPSN9a5aab8f-59b9-4d73-82c4-dc5b8fa8119e1
313407timolol 0.0025 MG/MG Ophthalmic GelSCD9a5aab8f-59b9-4d73-82c4-dc5b8fa8119e1
313408timolol 0.005 MG/MG Ophthalmic GelSCD9a5aab8f-59b9-4d73-82c4-dc5b8fa8119e1
313407timolol 0.25 % Ophthalmic GelSY9a5aab8f-59b9-4d73-82c4-dc5b8fa8119e1
313407timolol 0.25 % Ophthalmic Gel Forming SolutionSY9a5aab8f-59b9-4d73-82c4-dc5b8fa8119e1
313408timolol 0.5 % (as timolol maleate 6.8 MG/ML) Ophthalmic GelSY9a5aab8f-59b9-4d73-82c4-dc5b8fa8119e1
313408timolol 0.5 % Gel Forming Ophthalmic SolutionSY9a5aab8f-59b9-4d73-82c4-dc5b8fa8119e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
46708-545-05467080545051 BOTTLE in 1 CARTON (46708-545-05) / 5 mL in 1 BOTTLE1 bottle2020-11-22NoNoCurrent