FDA.reportPublic FDA data

Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution

Product NDC
65145-162
11-digit product format
651450162
Labeler code
65145
Product ID
65145-162_eac3cec2-b373-4936-89f0-c6d300e09f6e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Brimonidine Tartrate and Timolol Maleate
Dosage form
SOLUTION
Route
OPHTHALMIC
Labeler
Caplin Steriles Limited
Application
ANDA219093
Marketing category
ANDA
Marketing start
2025-03-10
Substance
BRIMONIDINE TARTRATE; TIMOLOL MALEATE
Active strength
2; 5 mg/mL; mg/mL
Pharmacologic classes
Adrenergic alpha-Agonists [MoA], Adrenergic beta-Antagonists [MoA], alpha-Adrenergic Agonist [EPC], 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
Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BRIMONIDINE TARTRATE2 mg/mL
TIMOLOL MALEATE5 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4S9CL2DY2H, P8Y54F701R
Rxcui861635

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6c0c444-a6ba-2fb5-a7bc-7f0443fa5791Product name420251208
8ec6541e-9842-115f-62bf-f7c9ab3aeddbProduct name320250805
73103a56-9f57-4f32-a306-a42bfa2fea36Product name120250505
425025fc-f910-4afe-815b-58d4486ed4f7Product name420250331
26c5ddae-5c69-622d-e599-5fd583634968Product name420250313
ee780602-134c-4c60-a2f0-e973ba549cd4Product name220250304
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
39b7fcf4-8865-6d40-d24d-9b8c28bd6345Product name520250123
03f77cb2-b4ad-3c11-8781-787b5ece4291Product name320240507
273981e4-09e7-45cc-967c-554f628ededfProduct name320230627
97dad5a2-c524-a7b5-dede-82edefe9ce62Product name720220929
c93ffd9a-5bad-44d8-b5e5-16ef4d2fee72Product name120220316
d11e749b-f93e-0ce3-ceda-28fe03d8081dProduct name220190731
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65145-162-01Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution5 mL in 1 BOTTLE, DROPPERSOLUTION51
65145-162-01Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution1 in 1 CARTONSOLUTION11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65145-162-01ML - Milliliter65145-162900218cd-b789-4ac1-9f14-8437d98f796d12025-07-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65145-162BRIMONIDINE TARTRATE/TIMOLOL MALEATE OPHTHALMIC SOLUTION (BRIMONIDINE TARTRATE AND TIMOLOL MALEATE) SOLUTION [CAPLIN STERILES LIMITED]1Current NDC, 2 package rows20250311_eac3cec2-b373-4936-89f0-c6d300e09f6e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861635brimonidine tartrate 0.2 % / timolol maleate 0.5 % Ophthalmic SolutionPSNeac3cec2-b373-4936-89f0-c6d300e09f6e1
861635brimonidine tartrate 2 MG/ML / timolol 5 MG/ML Ophthalmic SolutionSCDeac3cec2-b373-4936-89f0-c6d300e09f6e1
861635brimonidine tartrate 0.2 % / timolol 0.5 % (as timolol maleate 6.8 MG/ML) Ophthalmic SolutionSYeac3cec2-b373-4936-89f0-c6d300e09f6e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
65145-162-01651450162011 BOTTLE, DROPPER in 1 CARTON (65145-162-01) / 5 mL in 1 BOTTLE, DROPPER2025-03-10NoNoCurrent