FDA.reportPublic FDA data

SIMBRINZA

Product NDC
0065-4147
11-digit product format
000654147
Labeler code
0065
Product ID
0065-4147_889225d1-6257-4b32-b9cc-5f9c459c994a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
brinzolamide/brimonidine tartrate
Dosage form
SUSPENSION/ DROPS
Route
OPHTHALMIC
Labeler
Alcon Laboratories, Inc.
Application
NDA204251
Marketing category
NDA
Marketing start
2013-05-06
Substance
BRIMONIDINE TARTRATE; BRINZOLAMIDE
Active strength
2; 10 mg/mL; mg/mL
Pharmacologic classes
Adrenergic alpha-Agonists [MoA], Carbonic Anhydrase Inhibitor [EPC], Carbonic Anhydrase Inhibitors [MoA], alpha-Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
SIMBRINZA
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BRIMONIDINE TARTRATE2 mg/mL
BRINZOLAMIDE10 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4S9CL2DY2H, 9451Z89515
Rxcui1421451, 1421456

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6c0c444-a6ba-2fb5-a7bc-7f0443fa5791Product name420251208
8ec6541e-9842-115f-62bf-f7c9ab3aeddbProduct name320250805
39b7fcf4-8865-6d40-d24d-9b8c28bd6345Product name520250123
d597d8a7-d57c-dd3a-cf57-7366f3edcf30Product name420240828
c93ffd9a-5bad-44d8-b5e5-16ef4d2fee72Product name120220316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0065-4147-25SIMBRINZA2.5 mL in 1 BOTTLE, DROPPERSUSPENSION/ DROPS2.519
0065-4147-25SIMBRINZA1 in 1 CARTONSUSPENSION/ DROPS119
0065-4147-27SIMBRINZA8 mL in 1 BOTTLE, DROPPERSUSPENSION/ DROPS819
0065-4147-27SIMBRINZA1 in 1 CARTONSUSPENSION/ DROPS119

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0065-4147-27ML - Milliliter0065-4147635e0c00-0422-415c-a0e9-04020893f86c12013-06-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Brimonidine TartrateACTIVE INGREDIENT4S9CL2DY2HSIMBRINZA (BRINZOLAMIDE/BRIMONIDINE TARTRATE) SUSPENSION/ DROPS [ALCON LABORATORIES, INC.]8
BrinzolamideACTIVE INGREDIENT9451Z89515SIMBRINZA (BRINZOLAMIDE/BRIMONIDINE TARTRATE) SUSPENSION/ DROPS [ALCON LABORATORIES, INC.]8
BrimonidineACTIVE MOIETYE6GNX3HHTESIMBRINZA (BRINZOLAMIDE/BRIMONIDINE TARTRATE) SUSPENSION/ DROPS [ALCON LABORATORIES, INC.]8
BrinzolamideACTIVE MOIETY9451Z89515SIMBRINZA (BRINZOLAMIDE/BRIMONIDINE TARTRATE) SUSPENSION/ DROPS [ALCON LABORATORIES, INC.]8
Benzalkonium ChlorideINACTIVE INGREDIENTF5UM2KM3W7SIMBRINZA (BRINZOLAMIDE/BRIMONIDINE TARTRATE) SUSPENSION/ DROPS [ALCON LABORATORIES, INC.]8
Boric AcidINACTIVE INGREDIENTR57ZHV85D4SIMBRINZA (BRINZOLAMIDE/BRIMONIDINE TARTRATE) SUSPENSION/ DROPS [ALCON LABORATORIES, INC.]8
Carbomer Homopolymer Type B (allyl Pentaerythritol Crosslinked)INACTIVE INGREDIENTHHT01ZNK31SIMBRINZA (BRINZOLAMIDE/BRIMONIDINE TARTRATE) SUSPENSION/ DROPS [ALCON LABORATORIES, INC.]8
Hydrochloric AcidINACTIVE INGREDIENTQTT17582CBSIMBRINZA (BRINZOLAMIDE/BRIMONIDINE TARTRATE) SUSPENSION/ DROPS [ALCON LABORATORIES, INC.]8
MannitolINACTIVE INGREDIENT3OWL53L36ASIMBRINZA (BRINZOLAMIDE/BRIMONIDINE TARTRATE) SUSPENSION/ DROPS [ALCON LABORATORIES, INC.]8
Propylene GlycolINACTIVE INGREDIENT6DC9Q167V3SIMBRINZA (BRINZOLAMIDE/BRIMONIDINE TARTRATE) SUSPENSION/ DROPS [ALCON LABORATORIES, INC.]8
Sodium ChlorideINACTIVE INGREDIENT451W47IQ8XSIMBRINZA (BRINZOLAMIDE/BRIMONIDINE TARTRATE) SUSPENSION/ DROPS [ALCON LABORATORIES, INC.]8
Sodium HydroxideINACTIVE INGREDIENT55X04QC32ISIMBRINZA (BRINZOLAMIDE/BRIMONIDINE TARTRATE) SUSPENSION/ DROPS [ALCON LABORATORIES, INC.]8
TyloxapolINACTIVE INGREDIENTY27PUL9H56SIMBRINZA (BRINZOLAMIDE/BRIMONIDINE TARTRATE) SUSPENSION/ DROPS [ALCON LABORATORIES, INC.]8
WaterINACTIVE INGREDIENT059QF0KO0RSIMBRINZA (BRINZOLAMIDE/BRIMONIDINE TARTRATE) SUSPENSION/ DROPS [ALCON LABORATORIES, INC.]8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0065-4147SIMBRINZA (BRINZOLAMIDE/BRIMONIDINE TARTRATE) SUSPENSION/ DROPS [ALCON LABORATORIES, INC.]19Current NDC, Legacy NDC, 4 package rows20250316_a49c157e-6310-0011-7b7f-e26fc1820d59.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1421451brinzolamide 1 % / brimonidine tartrate 0.2 % Ophthalmic SuspensionPSNa49c157e-6310-0011-7b7f-e26fc1820d5919
1421456SIMBRINZA 1 % / 0.2 % Ophthalmic SuspensionPSNa49c157e-6310-0011-7b7f-e26fc1820d5919
1421456brimonidine tartrate 2 MG/ML / brinzolamide 10 MG/ML Ophthalmic Suspension [Simbrinza]SBDa49c157e-6310-0011-7b7f-e26fc1820d5919
1421451brimonidine tartrate 2 MG/ML / brinzolamide 10 MG/ML Ophthalmic SuspensionSCDa49c157e-6310-0011-7b7f-e26fc1820d5919
1421451brimonidine tartrate 0.2 % / brinzolamide 1 % Ophthalmic SuspensionSYa49c157e-6310-0011-7b7f-e26fc1820d5919
1421456Simbrinza (brimonidine tartrate 0.2 % / brinzolamide 1 % ) Ophthalmic SuspensionSYa49c157e-6310-0011-7b7f-e26fc1820d5919

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0065-4147-25000654147251 BOTTLE, DROPPER in 1 CARTON (0065-4147-25) / 2.5 mL in 1 BOTTLE, DROPPER2013-05-060000-00-00YesNoCurrent
0065-4147-27000654147271 BOTTLE, DROPPER in 1 CARTON (0065-4147-27) / 8 mL in 1 BOTTLE, DROPPER2013-05-060000-00-00NoNoCurrent