FDA.reportPublic FDA data

Timolol Maleate

Product NDC
50742-287
11-digit product format
507420287
Labeler code
50742
Product ID
50742-287_a6586769-4fb8-41df-bfd6-0971090ab79b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
timolol maleate
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Ingenus Pharmaceuticals, LLC
Application
ANDA216533
Marketing category
ANDA
Marketing start
2022-09-15
Substance
TIMOLOL MALEATE
Active strength
3.4 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 MALEATE3.4 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiP8Y54F701R
Rxcui1922876, 1922894

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
50742-287-04Timolol Maleate4 in 1 POUCHSOLUTION/ DROPS45
50742-287-04Timolol Maleate0.3 mL in 1 CONTAINERSOLUTION/ DROPS0.35
50742-287-60Timolol Maleate15 in 1 CARTONSOLUTION/ DROPS155

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50742-287-04EA - Each50742-287a85f6cb3-a0d6-41a3-aecf-507adc71e3a512023-08-08
50742-287-60EA - Each50742-287ff2292c2-969d-4bd2-8d20-c987aa19dddd12022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50742-287TIMOLOL MALEATE SOLUTION/ DROPS [INGENUS PHARMACEUTICALS, LLC]5Current NDC, Legacy NDC, 3 package rows20231130_4c4318b3-9865-4172-a7bd-9e68913eca1e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1922876timolol PF 0.25 % Ophthalmic SolutionPSN4c4318b3-9865-4172-a7bd-9e68913eca1e5
1922894timolol PF 0.5 % Ophthalmic SolutionPSN4c4318b3-9865-4172-a7bd-9e68913eca1e5
1922876Preservative-Free timolol 2.5 MG/ML Ophthalmic SolutionSCD4c4318b3-9865-4172-a7bd-9e68913eca1e5
1922894Preservative-Free timolol 5 MG/ML Ophthalmic SolutionSCD4c4318b3-9865-4172-a7bd-9e68913eca1e5
1922876timolol PF 0.25 % Ophthalmic SolutionSY4c4318b3-9865-4172-a7bd-9e68913eca1e5
1922894timolol PF 0.5 % Ophthalmic SolutionSY4c4318b3-9865-4172-a7bd-9e68913eca1e5
1922876timolol PF 2.5 MG/ML (as timolol maleate 3.4 MG/ML) Ophthalmic SolutionSY4c4318b3-9865-4172-a7bd-9e68913eca1e5
1922894timolol PF 5 MG/ML (as timolol maleate 6.8 MG/ML) Ophthalmic SolutionSY4c4318b3-9865-4172-a7bd-9e68913eca1e5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50742-287-04507420287044 in 1 POUCHHistorical
50742-287-605074202876015 POUCH in 1 CARTON (50742-287-60) / 4 CONTAINER in 1 POUCH (50742-287-04) / .3 mL in 1 CONTAINER15 pouch2022-09-150000-00-00NoNoCurrent