FDA.reportPublic FDA data

Brimonidine Tartrate/Timolol Maleate

Product NDC
68462-281
11-digit product format
684620281
Labeler code
68462
Product ID
68462-281_e97c8703-5166-49b6-8dd2-69c5b9dfcae8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Brimonidine Tartrate and Timolol Maleate
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Glenmark Pharmaceuticals Inc., USA
Application
ANDA214987
Marketing category
ANDA
Marketing start
2024-05-16
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Brimonidine Tartrate/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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68462-281-32Brimonidine Tartrate/Timolol Maleate1 in 1 CARTONSOLUTION/ DROPS13
68462-281-32Brimonidine Tartrate/Timolol Maleate10 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS103
68462-281-69Brimonidine Tartrate/Timolol Maleate5 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS53
68462-281-69Brimonidine Tartrate/Timolol Maleate1 in 1 CARTONSOLUTION/ DROPS13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68462-281-32ML - Milliliter68462-281faeafda9-4451-4528-af23-a2c8e09d694c12024-06-10
68462-281-69ML - Milliliter68462-28179ae782c-a9f6-4cb6-b59c-3da1f85c889612024-06-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68462-281BRIMONIDINE TARTRATE/TIMOLOL MALEATE (BRIMONIDINE TARTRATE AND TIMOLOL MALEATE) SOLUTION/ DROPS [GLENMARK PHARMACEUTICALS INC., USA]1Current NDC, 4 package rows20240518_bf6a7f59-5a10-49fe-9e57-19e3ba202918.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861635brimonidine tartrate 0.2 % / timolol maleate 0.5 % Ophthalmic SolutionPSNbf6a7f59-5a10-49fe-9e57-19e3ba2029183
861635brimonidine tartrate 2 MG/ML / timolol 5 MG/ML Ophthalmic SolutionSCDbf6a7f59-5a10-49fe-9e57-19e3ba2029183
861635brimonidine tartrate 0.2 % / timolol 0.5 % (as timolol maleate 6.8 MG/ML) Ophthalmic SolutionSYbf6a7f59-5a10-49fe-9e57-19e3ba2029183

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68462-281-32684620281321 BOTTLE, DROPPER in 1 CARTON (68462-281-32) / 10 mL in 1 BOTTLE, DROPPER2024-05-16NoNoHistorical
68462-281-69684620281691 BOTTLE, DROPPER in 1 CARTON (68462-281-69) / 5 mL in 1 BOTTLE, DROPPER2024-05-16NoNoHistorical