COMBIGAN

Product NDC
0023-9211
11-digit product format
000239211
Labeler code
0023
Product ID
0023-9211_fa68af94-117a-436f-a3ea-cd0edde443d4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
brimonidine tartrate, timolol maleate
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Allergan, Inc.
Application
NDA021398
Marketing category
NDA
Marketing start
2007-11-14
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
N021398-001COMBIGANBRIMONIDINE TARTRATE; TIMOLOL MALEATE0.2%;EQ 0.5% BASESOLUTION/DROPS / OPHTHALMICABRLD, RS2007-10-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N021398-001AB

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.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N021398-001COMBIGAN0.2%;EQ 0.5% BASESOLUTION/DROPS / OPHTHALMICABRLD, RS2007-10-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021398-001COMBIGAN0.2%;EQ 0.5% BASESOLUTION/DROPS / OPHTHALMICABRLD, RS2007-10-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08N021398-001COMBIGAN0.2%;EQ 0.5% BASESOLUTION/DROPS / OPHTHALMICABRLD, RS2007-10-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021398-001COMBIGAN0.2%;EQ 0.5% BASESOLUTION/DROPS / OPHTHALMICABRLD, RS2007-10-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021398-001COMBIGAN0.2%;EQ 0.5% BASESOLUTION/DROPS / OPHTHALMICABRLD, RS2007-10-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021398-001COMBIGAN0.2%;EQ 0.5% BASESOLUTION/DROPS / OPHTHALMICABRLD, RS2007-10-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021398-001COMBIGAN0.2%;EQ 0.5% BASESOLUTION/DROPS / OPHTHALMICABRLD, RS2007-10-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021398-001COMBIGAN0.2%;EQ 0.5% BASESOLUTION/DROPS / OPHTHALMICABRLD, RS2007-10-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021398-001COMBIGAN0.2%;EQ 0.5% BASESOLUTION/DROPS / OPHTHALMICABRLD, RS2007-10-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021398-001COMBIGAN0.2%;EQ 0.5% BASESOLUTION/DROPS / OPHTHALMICABRLD, RS2007-10-30d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021398-001COMBIGAN0.2%;EQ 0.5% BASESOLUTION/DROPS / OPHTHALMICABRLD, RS2007-10-3079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021398-001COMBIGAN0.2%;EQ 0.5% BASESOLUTION/DROPS / OPHTHALMICABRLD, RS2007-10-30301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021398-001COMBIGAN0.2%;EQ 0.5% BASESOLUTION/DROPS / OPHTHALMICABRLD, RS2007-10-301e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021398-001COMBIGAN0.2%;EQ 0.5% BASESOLUTION/DROPS / OPHTHALMICABRLD, RS2007-10-308072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021398-001COMBIGAN0.2%;EQ 0.5% BASESOLUTION/DROPS / OPHTHALMICABRLD, RS2007-10-305c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021398-001COMBIGAN0.2%;EQ 0.5% BASESOLUTION/DROPS / OPHTHALMICABRLD, RS2007-10-305d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021398-001COMBIGAN0.2%;EQ 0.5% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2007-10-304b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021398-001COMBIGAN0.2%;EQ 0.5% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2007-10-3074a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021398-001COMBIGAN0.2%;EQ 0.5% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2007-10-30bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021398-001COMBIGAN0.2%;EQ 0.5% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2007-10-30782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021398-001COMBIGAN0.2%;EQ 0.5% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2007-10-3087673890dc5c…
2021-03-12 10:30 UTC2021-03N021398-001COMBIGAN0.2%;EQ 0.5% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2007-10-305aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N021398-001COMBIGAN0.2%;EQ 0.5% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2007-10-308869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021398-001COMBIGAN0.2%;EQ 0.5% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2007-10-30c0c555d07b60…
2019-12-14 00:12 UTC2019-12N021398-001COMBIGAN0.2%;EQ 0.5% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2007-10-303f01610625f2…
2019-09-15 20:21 UTC2019-09N021398-001COMBIGAN0.2%;EQ 0.5% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2007-10-30b00525d2431f…
2019-07-19 19:46 UTC2019-07N021398-001COMBIGAN0.2%;EQ 0.5% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2007-10-30ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N021398-001COMBIGAN0.2%;EQ 0.5% BASESOLUTION/DROPS / OPHTHALMICABRLD, RS2007-10-306a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N021398-001COMBIGAN0.2%;EQ 0.5% BASESOLUTION/DROPS / OPHTHALMICABRLD, RS2007-10-301c564ffb4f44…
2023-12-20 04:57 UTC2023-12N021398-001COMBIGAN0.2%;EQ 0.5% BASESOLUTION/DROPS / OPHTHALMICABRLD, RS2007-10-30ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N021398-001COMBIGAN0.2%;EQ 0.5% BASESOLUTION/DROPS / OPHTHALMICABRLD, RS2007-10-30a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N021398-001COMBIGAN0.2%;EQ 0.5% BASESOLUTION/DROPS / OPHTHALMICABRLD, RS2007-10-309b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N021398-001COMBIGAN0.2%;EQ 0.5% BASESOLUTION/DROPS / OPHTHALMICABRLD, RS2007-10-30a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N021398-001COMBIGAN0.2%;EQ 0.5% BASESOLUTION/DROPS / OPHTHALMICABRLD, RS2007-10-303f0d92c62455…
2023-05-13 08:27 UTC2023-05N021398-001COMBIGAN0.2%;EQ 0.5% BASESOLUTION/DROPS / OPHTHALMICABRLD, RS2007-10-30053a50430f4f…
2023-01-26 05:58 UTC2023-01N021398-001COMBIGAN0.2%;EQ 0.5% BASESOLUTION/DROPS / OPHTHALMICABRLD, RS2007-10-303bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N021398-001COMBIGAN0.2%;EQ 0.5% BASESOLUTION/DROPS / OPHTHALMICABRLD, RS2007-10-303a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N021398-001COMBIGAN0.2%;EQ 0.5% BASESOLUTION/DROPS / OPHTHALMICABRLD, RS2007-10-30f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N021398-001COMBIGAN0.2%;EQ 0.5% BASESOLUTION/DROPS / OPHTHALMICABRLD, RS2007-10-30e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N021398-001COMBIGAN0.2%;EQ 0.5% BASESOLUTION/DROPS / OPHTHALMICABRLD, RS2007-10-30cb3db0bc1861…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N021398-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021398-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N021398-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021398-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021398-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021398-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021398-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021398-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021398-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021398-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021398-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021398-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021398-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021398-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021398-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021398-001AB15d02ea3f76ae…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N021398-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N021398-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N021398-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N021398-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N021398-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N021398-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N021398-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05N021398-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01N021398-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N021398-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N021398-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N021398-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N021398-001AB1cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N021398-001AB1a50c72e98297…

Observed Orange Book patent history#

Patent history page 1 of 5 · 188 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021398-00170301492022-04-19U-8495c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021398-00173209762022-04-19U-8495c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021398-00176422582022-04-19U-1024Drug substance, Drug product5c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021398-00181338902022-04-19U-12352012-04-025c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021398-00183544092022-04-19U-1371Drug product2013-03-275c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021398-00187484252022-04-19U-1524Drug product2014-07-075c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021398-00194747512022-04-19U-1524Drug product2016-10-255c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021398-00197704532022-04-19U-2131Drug product2017-10-125c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021398-00199078012022-04-19U-2239Drug product2018-03-075c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021398-00199078022022-04-19U-2240Drug product2018-03-075c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021398-00170301492022-04-19U-8495d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021398-00173209762022-04-19U-8495d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021398-00176422582022-04-19U-1024Drug substance, Drug product5d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021398-00181338902022-04-19U-12352012-04-025d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021398-00183544092022-04-19U-1371Drug product2013-03-275d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021398-00187484252022-04-19U-1524Drug product2014-07-075d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021398-00194747512022-04-19U-1524Drug product2016-10-255d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021398-00197704532022-04-19U-2131Drug product2017-10-125d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021398-00199078012022-04-19U-2239Drug product2018-03-075d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021398-00199078022022-04-19U-2240Drug product2018-03-075d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021398-00173234632023-01-19Drug product, Delist requested5d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021398-00170301492022-04-19U-8494b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021398-00173209762022-04-19U-8494b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021398-00176422582022-04-19U-1024Drug substance, Drug product4b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021398-00181338902022-04-19U-12352012-04-024b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021398-00183544092022-04-19U-1371Drug product2013-03-274b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021398-00187484252022-04-19U-1524Drug product2014-07-074b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021398-00194747512022-04-19U-1524Drug product2016-10-254b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021398-00197704532022-04-19U-2131Drug product2017-10-124b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021398-00199078012022-04-19U-2239Drug product2018-03-074b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021398-00199078022022-04-19U-2240Drug product2018-03-074b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021398-00173234632023-01-19Drug product, Delist requested4b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021398-00170301492022-04-19U-84974a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021398-00173209762022-04-19U-84974a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021398-00176422582022-04-19U-1024Drug substance, Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021398-00181338902022-04-19U-12352012-04-0274a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021398-00183544092022-04-19U-1371Drug product2013-03-2774a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021398-00187484252022-04-19U-1524Drug product2014-07-0774a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021398-00194747512022-04-19U-1524Drug product2016-10-2574a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021398-00197704532022-04-19U-2131Drug product2017-10-1274a2ff9319b5…

Additional Listing Data#

Finished product
Yes
Brand name base
COMBIGAN
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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
861635Internal RxNorm lookup
861637Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
feaf1480-a4b8-4486-992a-96be3a596243Available 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
0023-9211-03COMBIGAN1 in 1 CARTONSOLUTION/ DROPS122
0023-9211-03COMBIGAN2.5 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS2.522
0023-9211-05COMBIGAN1 in 1 CARTONSOLUTION/ DROPS122
0023-9211-05COMBIGAN5 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS522
0023-9211-10COMBIGAN10 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS1022
0023-9211-10COMBIGAN1 in 1 CARTONSOLUTION/ DROPS122
0023-9211-15COMBIGAN1 in 1 CARTONSOLUTION/ DROPS122
0023-9211-15COMBIGAN15 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS1522

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0023-9211-05ML - Milliliter0023-921131c9e036-987e-4a7e-b66c-4b29ba37b6bb12012-07-24
0023-9211-10ML - Milliliter0023-9211aa1373b8-07c1-4f1c-b6ec-fa6ee8edbef712012-07-24
0023-9211-15ML - Milliliter0023-92115cb3c57b-4132-484b-8735-9f1dc2fae31c12016-11-08

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
brimonidine tartrateACTIVE INGREDIENT4S9CL2DY2HCOMBIGAN (BRIMONIDINE TARTRATE, TIMOLOL MALEATE) SOLUTION/ DROPS [ALLERGAN, INC.]9
timolol maleateACTIVE INGREDIENTP8Y54F701RCOMBIGAN (BRIMONIDINE TARTRATE, TIMOLOL MALEATE) SOLUTION/ DROPS [ALLERGAN, INC.]9
brimonidineACTIVE MOIETYE6GNX3HHTECOMBIGAN (BRIMONIDINE TARTRATE, TIMOLOL MALEATE) SOLUTION/ DROPS [ALLERGAN, INC.]9
timolol anhydrousACTIVE MOIETY5JKY92S7BRCOMBIGAN (BRIMONIDINE TARTRATE, TIMOLOL MALEATE) SOLUTION/ DROPS [ALLERGAN, INC.]9
benzalkonium chlorideINACTIVE INGREDIENTF5UM2KM3W7COMBIGAN (BRIMONIDINE TARTRATE, TIMOLOL MALEATE) SOLUTION/ DROPS [ALLERGAN, INC.]9
hydrochloric acidINACTIVE INGREDIENTQTT17582CBCOMBIGAN (BRIMONIDINE TARTRATE, TIMOLOL MALEATE) SOLUTION/ DROPS [ALLERGAN, INC.]9
sodium hydroxideINACTIVE INGREDIENT55X04QC32ICOMBIGAN (BRIMONIDINE TARTRATE, TIMOLOL MALEATE) SOLUTION/ DROPS [ALLERGAN, INC.]9
sodium phosphate, dibasicINACTIVE INGREDIENTGR686LBA74COMBIGAN (BRIMONIDINE TARTRATE, TIMOLOL MALEATE) SOLUTION/ DROPS [ALLERGAN, INC.]9
sodium phosphate, monobasicINACTIVE INGREDIENT3980JIH2SWCOMBIGAN (BRIMONIDINE TARTRATE, TIMOLOL MALEATE) SOLUTION/ DROPS [ALLERGAN, INC.]9
waterINACTIVE INGREDIENT059QF0KO0RCOMBIGAN (BRIMONIDINE TARTRATE, TIMOLOL MALEATE) SOLUTION/ DROPS [ALLERGAN, INC.]9
brimonidine tartrateACTIVE INGREDIENT4S9CL2DY2HCOMBIGAN (BRIMONIDINE TARTRATE, TIMOLOL MALEATE) SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.]1
timolol maleateACTIVE INGREDIENTP8Y54F701RCOMBIGAN (BRIMONIDINE TARTRATE, TIMOLOL MALEATE) SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.]1
brimonidineACTIVE MOIETYE6GNX3HHTECOMBIGAN (BRIMONIDINE TARTRATE, TIMOLOL MALEATE) SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.]1
timololACTIVE MOIETY817W3C6175COMBIGAN (BRIMONIDINE TARTRATE, TIMOLOL MALEATE) SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.]1
benzalkonium chlorideINACTIVE INGREDIENTF5UM2KM3W7COMBIGAN (BRIMONIDINE TARTRATE, TIMOLOL MALEATE) SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.]1
hydrochloric acidINACTIVE INGREDIENTQTT17582CBCOMBIGAN (BRIMONIDINE TARTRATE, TIMOLOL MALEATE) SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.]1
sodium hydroxideINACTIVE INGREDIENT55X04QC32ICOMBIGAN (BRIMONIDINE TARTRATE, TIMOLOL MALEATE) SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.]1
sodium phosphate, dibasicINACTIVE INGREDIENTGR686LBA74COMBIGAN (BRIMONIDINE TARTRATE, TIMOLOL MALEATE) SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.]1
sodium phosphate, monobasicINACTIVE INGREDIENT3980JIH2SWCOMBIGAN (BRIMONIDINE TARTRATE, TIMOLOL MALEATE) SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.]1
waterINACTIVE INGREDIENT059QF0KO0RCOMBIGAN (BRIMONIDINE TARTRATE, TIMOLOL MALEATE) SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0023-9211COMBIGAN (BRIMONIDINE TARTRATE, TIMOLOL MALEATE) SOLUTION/ DROPS [ALLERGAN, INC.]21Current NDC, Legacy NDC, 8 package rows20241108_feaf1480-a4b8-4486-992a-96be3a596243.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
COMBIGANBRIMONIDINE TARTRATE, TIMOLOL MALEATEAllergan, Inc.feaf1480-a4b8-4486-992a-96be3a5962432026-03-17Warnings, Adverse reactionsExact identifier
application applno (NDA): 021398
application number: NDA021398
ndc (product): 0023-9211

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861635brimonidine tartrate 0.2 % / timolol maleate 0.5 % Ophthalmic SolutionPSNfeaf1480-a4b8-4486-992a-96be3a59624322
861637Combigan 0.2 % / 0.5 % Ophthalmic SolutionPSNfeaf1480-a4b8-4486-992a-96be3a59624322
861637brimonidine tartrate 2 MG/ML / timolol 5 MG/ML Ophthalmic Solution [Combigan]SBDfeaf1480-a4b8-4486-992a-96be3a59624322
861635brimonidine tartrate 2 MG/ML / timolol 5 MG/ML Ophthalmic SolutionSCDfeaf1480-a4b8-4486-992a-96be3a59624322
861635brimonidine tartrate 0.2 % / timolol 0.5 % (as timolol maleate 6.8 MG/ML) Ophthalmic SolutionSYfeaf1480-a4b8-4486-992a-96be3a59624322
861637Combigan (brimonidine tartrate 0.2 % / timolol 0.5 % ) Ophthalmic SolutionSYfeaf1480-a4b8-4486-992a-96be3a59624322
861635brimonidine tartrate 0.2 % / timolol maleate 0.5 % Ophthalmic SolutionPSN8c641b6c-3335-4ec3-89b9-2d97a89010621
861637Combigan 0.2 % / 0.5 % Ophthalmic SolutionPSN8c641b6c-3335-4ec3-89b9-2d97a89010621
861637brimonidine tartrate 2 MG/ML / timolol 5 MG/ML Ophthalmic Solution [Combigan]SBD8c641b6c-3335-4ec3-89b9-2d97a89010621
861635brimonidine tartrate 2 MG/ML / timolol 5 MG/ML Ophthalmic SolutionSCD8c641b6c-3335-4ec3-89b9-2d97a89010621
861635brimonidine tartrate 0.2 % / timolol 0.5 % (as timolol maleate 6.8 MG/ML) Ophthalmic SolutionSY8c641b6c-3335-4ec3-89b9-2d97a89010621
861637Combigan (brimonidine tartrate 0.2 % / timolol 0.5 % ) Ophthalmic SolutionSY8c641b6c-3335-4ec3-89b9-2d97a89010621

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0023-9211-03000239211031 BOTTLE, DROPPER in 1 CARTON (0023-9211-03) / 2.5 mL in 1 BOTTLE, DROPPER2007-11-140000-00-00YesNoCurrent
0023-9211-05000239211051 BOTTLE, DROPPER in 1 CARTON (0023-9211-05) / 5 mL in 1 BOTTLE, DROPPER2007-11-140000-00-00NoNoCurrent
0023-9211-10000239211101 BOTTLE, DROPPER in 1 CARTON (0023-9211-10) / 10 mL in 1 BOTTLE, DROPPER2007-11-140000-00-00NoNoCurrent
0023-9211-15000239211151 BOTTLE, DROPPER in 1 CARTON (0023-9211-15) / 15 mL in 1 BOTTLE, DROPPER2007-11-140000-00-00NoNoCurrent