FDA.reportPublic FDA data

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

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 Identifiers#

Field, Values table
FieldValues
Unii4S9CL2DY2H, P8Y54F701R
Rxcui861635, 861637

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

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