FDA.reportPublic FDA data

TIMOLOL MALEATE

Product NDC
69315-325
11-digit product format
693150325
Labeler code
69315
Product ID
69315-325_b6fecc68-5e40-4191-a365-568ccedf0697
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TIMOLOL MALEATE
Dosage form
SOLUTION
Route
OPHTHALMIC
Labeler
Leading Pharma, LLC
Application
ANDA218460
Marketing category
ANDA
Marketing start
2024-11-07
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
Rxcui1992303

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
69315-325-05TIMOLOL MALEATE5 mL in 1 BOTTLE, PLASTICSOLUTION51
69315-325-10TIMOLOL MALEATE10 mL in 1 BOTTLE, PLASTICSOLUTION101
69315-325-15TIMOLOL MALEATE15 mL in 1 BOTTLE, PLASTICSOLUTION151

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69315-325-05ML - Milliliter69315-325b385023c-8084-4b59-a36c-22492c7c005312024-12-10
69315-325-10ML - Milliliter69315-325f1d30037-f3b6-4202-86ee-bf758308d59912024-12-10
69315-325-15ML - Milliliter69315-325a93ca44e-201d-4c69-92b3-421aefa3e44b12024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69315-325TIMOLOL MALEATE SOLUTION [LEADING PHARMA, LLC]1Current NDC, 3 package rows20241108_d6fa2971-dacf-42ab-99bc-c7ce6013221e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1992303timolol 0.5 % 12HR Ophthalmic SolutionPSNd6fa2971-dacf-42ab-99bc-c7ce6013221e1
199230312 HR timolol 5 MG/ML Ophthalmic SolutionSCDd6fa2971-dacf-42ab-99bc-c7ce6013221e1
1992303timolol 0.5 % (as timolol maleate 6.8 MG/ML) 12 HR Ophthalmic SolutionSYd6fa2971-dacf-42ab-99bc-c7ce6013221e1
1992303timolol 0.5 % 12 HR Ophthalmic SolutionSYd6fa2971-dacf-42ab-99bc-c7ce6013221e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69315-325-05693150325055 mL in 1 BOTTLE, PLASTIC (69315-325-05) 5 ml2024-11-07NoNoHistorical
69315-325-106931503251010 mL in 1 BOTTLE, PLASTIC (69315-325-10) 10 ml2024-11-07NoNoHistorical
69315-325-156931503251515 mL in 1 BOTTLE, PLASTIC (69315-325-15) 15 ml2024-11-07NoNoHistorical