FDA.reportPublic FDA data

Brimonidine Tartrate and Timolol Maleate

Product NDC
0781-7186
11-digit product format
007817186
Labeler code
0781
Product ID
0781-7186_936fadf8-8b5d-48cf-a875-0fe182a9d41a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Brimonidine Tartrate and Timolol Maleate
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Sandoz Inc
Application
ANDA091087
Marketing category
ANDA
Marketing start
2022-04-13
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 and Timolol Maleate
Listing expiration
2027-12-31

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
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0781-7186-702024-09-30C16284748780-11030e365-17ce-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use BRIMONIDINE TARTRATE AND TIMOLOL MALEATE OPHTHALMIC SOLUTION safely and effectively. See full prescribing information for BRIMONIDINE TARTRATE AND TIMOLOL MALEATE OPHTHALMIC SOLUTION. BRIMONIDINE TARTRATE AND TIMOLOL MALEATE ophthalmic solution, for topical ophthalmic use Initial U.S. Approval: 2007
0781-7186-702024-09-30C16284748780-11030e365-17ce-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use BRIMONIDINE TARTRATE AND TIMOLOL MALEATE OPHTHALMIC SOLUTION safely and effectively. See full prescribing information for BRIMONIDINE TARTRATE AND TIMOLOL MALEATE OPHTHALMIC SOLUTION. BRIMONIDINE TARTRATE AND TIMOLOL MALEATE ophthalmic solution. For Topical Administration. Initial U.S. Approval: 2007
0781-7186-752024-09-30C16284748780-11030e365-17ce-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use BRIMONIDINE TARTRATE AND TIMOLOL MALEATE OPHTHALMIC SOLUTION safely and effectively. See full prescribing information for BRIMONIDINE TARTRATE AND TIMOLOL MALEATE OPHTHALMIC SOLUTION. BRIMONIDINE TARTRATE AND TIMOLOL MALEATE ophthalmic solution, for topical ophthalmic use Initial U.S. Approval: 2007
0781-7186-752024-09-30C16284748780-11030e365-17ce-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use BRIMONIDINE TARTRATE AND TIMOLOL MALEATE OPHTHALMIC SOLUTION safely and effectively. See full prescribing information for BRIMONIDINE TARTRATE AND TIMOLOL MALEATE OPHTHALMIC SOLUTION. BRIMONIDINE TARTRATE AND TIMOLOL MALEATE ophthalmic solution. For Topical Administration. Initial U.S. Approval: 2007
0781-7186-852024-09-30C16284748780-11030e365-17ce-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use BRIMONIDINE TARTRATE AND TIMOLOL MALEATE OPHTHALMIC SOLUTION safely and effectively. See full prescribing information for BRIMONIDINE TARTRATE AND TIMOLOL MALEATE OPHTHALMIC SOLUTION. BRIMONIDINE TARTRATE AND TIMOLOL MALEATE ophthalmic solution, for topical ophthalmic use Initial U.S. Approval: 2007
0781-7186-852024-09-30C16284748780-11030e365-17ce-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use BRIMONIDINE TARTRATE AND TIMOLOL MALEATE OPHTHALMIC SOLUTION safely and effectively. See full prescribing information for BRIMONIDINE TARTRATE AND TIMOLOL MALEATE OPHTHALMIC SOLUTION. BRIMONIDINE TARTRATE AND TIMOLOL MALEATE ophthalmic solution. For Topical Administration. Initial U.S. Approval: 2007
0781-7186-702024-07-30C16284748780-11030e365-17ce-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use BRIMONIDINE TARTRATE AND TIMOLOL MALEATE OPHTHALMIC SOLUTION safely and effectively. See full prescribing information for BRIMONIDINE TARTRATE AND TIMOLOL MALEATE OPHTHALMIC SOLUTION. BRIMONIDINE TARTRATE AND TIMOLOL MALEATE ophthalmic solution, for topical ophthalmic use Initial U.S. Approval: 2007
0781-7186-702024-07-30C16284748780-11030e365-17ce-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use BRIMONIDINE TARTRATE AND TIMOLOL MALEATE OPHTHALMIC SOLUTION safely and effectively. See full prescribing information for BRIMONIDINE TARTRATE AND TIMOLOL MALEATE OPHTHALMIC SOLUTION. BRIMONIDINE TARTRATE AND TIMOLOL MALEATE ophthalmic solution. For Topical Administration. Initial U.S. Approval: 2007
0781-7186-752024-07-30C16284748780-11030e365-17ce-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use BRIMONIDINE TARTRATE AND TIMOLOL MALEATE OPHTHALMIC SOLUTION safely and effectively. See full prescribing information for BRIMONIDINE TARTRATE AND TIMOLOL MALEATE OPHTHALMIC SOLUTION. BRIMONIDINE TARTRATE AND TIMOLOL MALEATE ophthalmic solution, for topical ophthalmic use Initial U.S. Approval: 2007
0781-7186-752024-07-30C16284748780-11030e365-17ce-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use BRIMONIDINE TARTRATE AND TIMOLOL MALEATE OPHTHALMIC SOLUTION safely and effectively. See full prescribing information for BRIMONIDINE TARTRATE AND TIMOLOL MALEATE OPHTHALMIC SOLUTION. BRIMONIDINE TARTRATE AND TIMOLOL MALEATE ophthalmic solution. For Topical Administration. Initial U.S. Approval: 2007
0781-7186-852024-07-30C16284748780-11030e365-17ce-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use BRIMONIDINE TARTRATE AND TIMOLOL MALEATE OPHTHALMIC SOLUTION safely and effectively. See full prescribing information for BRIMONIDINE TARTRATE AND TIMOLOL MALEATE OPHTHALMIC SOLUTION. BRIMONIDINE TARTRATE AND TIMOLOL MALEATE ophthalmic solution, for topical ophthalmic use Initial U.S. Approval: 2007
0781-7186-852024-07-30C16284748780-11030e365-17ce-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use BRIMONIDINE TARTRATE AND TIMOLOL MALEATE OPHTHALMIC SOLUTION safely and effectively. See full prescribing information for BRIMONIDINE TARTRATE AND TIMOLOL MALEATE OPHTHALMIC SOLUTION. BRIMONIDINE TARTRATE AND TIMOLOL MALEATE ophthalmic solution. For Topical Administration. Initial U.S. Approval: 2007
0781-7186-702024-01-30C16284748780-11030e365-17ce-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use BRIMONIDINE TARTRATE AND TIMOLOL MALEATE OPHTHALMIC SOLUTION safely and effectively. See full prescribing information for BRIMONIDINE TARTRATE AND TIMOLOL MALEATE OPHTHALMIC SOLUTION. BRIMONIDINE TARTRATE AND TIMOLOL MALEATE ophthalmic solution, for topical ophthalmic use Initial U.S. Approval: 2007
0781-7186-702024-01-30C16284748780-11030e365-17ce-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use BRIMONIDINE TARTRATE AND TIMOLOL MALEATE OPHTHALMIC SOLUTION safely and effectively. See full prescribing information for BRIMONIDINE TARTRATE AND TIMOLOL MALEATE OPHTHALMIC SOLUTION. BRIMONIDINE TARTRATE AND TIMOLOL MALEATE ophthalmic solution. For Topical Administration. Initial U.S. Approval: 2007
0781-7186-752024-01-30C16284748780-11030e365-17ce-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use BRIMONIDINE TARTRATE AND TIMOLOL MALEATE OPHTHALMIC SOLUTION safely and effectively. See full prescribing information for BRIMONIDINE TARTRATE AND TIMOLOL MALEATE OPHTHALMIC SOLUTION. BRIMONIDINE TARTRATE AND TIMOLOL MALEATE ophthalmic solution, for topical ophthalmic use Initial U.S. Approval: 2007
0781-7186-752024-01-30C16284748780-11030e365-17ce-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use BRIMONIDINE TARTRATE AND TIMOLOL MALEATE OPHTHALMIC SOLUTION safely and effectively. See full prescribing information for BRIMONIDINE TARTRATE AND TIMOLOL MALEATE OPHTHALMIC SOLUTION. BRIMONIDINE TARTRATE AND TIMOLOL MALEATE ophthalmic solution. For Topical Administration. Initial U.S. Approval: 2007
0781-7186-852024-01-30C16284748780-11030e365-17ce-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use BRIMONIDINE TARTRATE AND TIMOLOL MALEATE OPHTHALMIC SOLUTION safely and effectively. See full prescribing information for BRIMONIDINE TARTRATE AND TIMOLOL MALEATE OPHTHALMIC SOLUTION. BRIMONIDINE TARTRATE AND TIMOLOL MALEATE ophthalmic solution, for topical ophthalmic use Initial U.S. Approval: 2007
0781-7186-852024-01-30C16284748780-11030e365-17ce-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use BRIMONIDINE TARTRATE AND TIMOLOL MALEATE OPHTHALMIC SOLUTION safely and effectively. See full prescribing information for BRIMONIDINE TARTRATE AND TIMOLOL MALEATE OPHTHALMIC SOLUTION. BRIMONIDINE TARTRATE AND TIMOLOL MALEATE ophthalmic solution. For Topical Administration. Initial U.S. Approval: 2007

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0781-7186-70Brimonidine Tartrate and Timolol Maleate1 in 1 CARTONSOLUTION/ DROPS115
0781-7186-70Brimonidine Tartrate and Timolol Maleate10 mL in 1 BOTTLESOLUTION/ DROPS1015
0781-7186-75Brimonidine Tartrate and Timolol Maleate1 in 1 CARTONSOLUTION/ DROPS115
0781-7186-75Brimonidine Tartrate and Timolol Maleate5 mL in 1 BOTTLESOLUTION/ DROPS515
0781-7186-85Brimonidine Tartrate and Timolol Maleate1 in 1 CARTONSOLUTION/ DROPS115
0781-7186-85Brimonidine Tartrate and Timolol Maleate15 mL in 1 BOTTLESOLUTION/ DROPS1515

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0781-7186-70ML - Milliliter0781-71860bf9df64-43f4-4662-aad0-cca3a893331812022-05-04
0781-7186-75ML - Milliliter0781-7186ea81ab37-326f-42e6-bda3-300d748820ad12022-05-04
0781-7186-85ML - Milliliter0781-7186fc411281-2c48-4cdf-9ce5-cfe6bb08efe012022-05-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0781-7186BRIMONIDINE TARTRATE AND TIMOLOL MALEATE SOLUTION/ DROPS [SANDOZ INC]13Current NDC, Legacy NDC, 6 package rows20241003_af21d2e5-0029-4889-ba93-6417baa91ce6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861635brimonidine tartrate 0.2 % / timolol maleate 0.5 % Ophthalmic SolutionPSNaf21d2e5-0029-4889-ba93-6417baa91ce616
861635brimonidine tartrate 2 MG/ML / timolol 5 MG/ML Ophthalmic SolutionSCDaf21d2e5-0029-4889-ba93-6417baa91ce616
861635brimonidine tartrate 0.2 % / timolol 0.5 % (as timolol maleate 6.8 MG/ML) Ophthalmic SolutionSYaf21d2e5-0029-4889-ba93-6417baa91ce616

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0781-7186-70007817186701 BOTTLE in 1 CARTON (0781-7186-70) / 10 mL in 1 BOTTLE1 bottle2022-04-130000-00-00NoNoCurrent
0781-7186-75007817186751 BOTTLE in 1 CARTON (0781-7186-75) / 5 mL in 1 BOTTLE1 bottle2022-04-130000-00-00NoNoCurrent
0781-7186-85007817186851 BOTTLE in 1 CARTON (0781-7186-85) / 15 mL in 1 BOTTLE1 bottle2022-04-130000-00-00NoNoCurrent