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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A214987-001BRIMONIDINE TARTRATE AND TIMOLOL MALEATEBRIMONIDINE TARTRATE; TIMOLOL MALEATE0.2%;EQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAB2024-05-16

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A214987-001AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A214987-001BRIMONIDINE TARTRATE AND TIMOLOL MALEATE0.2%;EQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAB2024-05-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214987-001BRIMONIDINE TARTRATE AND TIMOLOL MALEATE0.2%;EQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAB2024-05-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08A214987-001BRIMONIDINE TARTRATE AND TIMOLOL MALEATE0.2%;EQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAB2024-05-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214987-001BRIMONIDINE TARTRATE AND TIMOLOL MALEATE0.2%;EQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAB2024-05-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214987-001BRIMONIDINE TARTRATE AND TIMOLOL MALEATE0.2%;EQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAB2024-05-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214987-001BRIMONIDINE TARTRATE AND TIMOLOL MALEATE0.2%;EQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAB2024-05-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214987-001BRIMONIDINE TARTRATE AND TIMOLOL MALEATE0.2%;EQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAB2024-05-162680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214987-001BRIMONIDINE TARTRATE AND TIMOLOL MALEATE0.2%;EQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAB2024-05-165bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214987-001BRIMONIDINE TARTRATE AND TIMOLOL MALEATE0.2%;EQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAB2024-05-16d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A214987-001BRIMONIDINE TARTRATE AND TIMOLOL MALEATE0.2%;EQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAB2024-05-16d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214987-001BRIMONIDINE TARTRATE AND TIMOLOL MALEATE0.2%;EQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAB2024-05-1679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214987-001BRIMONIDINE TARTRATE AND TIMOLOL MALEATE0.2%;EQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAB2024-05-16301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A214987-001BRIMONIDINE TARTRATE AND TIMOLOL MALEATE0.2%;EQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAB2024-05-161e350fbaab3a…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A214987-001BRIMONIDINE TARTRATE AND TIMOLOL MALEATE0.2%;EQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAB2024-05-16a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A214987-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214987-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A214987-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214987-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214987-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214987-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214987-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214987-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214987-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A214987-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214987-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214987-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A214987-001AB11e350fbaab3a…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A214987-001AB1a50c72e98297…

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 UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4S9CL2DY2HInternal UNII lookup
P8Y54F701RInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
861635Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
bf6a7f59-5a10-49fe-9e57-19e3ba202918Available on FDA.report

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Brimonidine Tartrate/Timolol MaleateBRIMONIDINE TARTRATE AND TIMOLOL MALEATEGlenmark Pharmaceuticals Inc., USAbf6a7f59-5a10-49fe-9e57-19e3ba2029182026-05-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214987
application number: ANDA214987
ndc (product): 68462-281

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, DROPPER2024-05-16NoNoCurrent
68462-281-69684620281691 BOTTLE, DROPPER in 1 CARTON (68462-281-69) / 5 mL in 1 BOTTLE, DROPPER2024-05-16NoNoCurrent