SIMBRINZA
These highlights do not include all the information needed to use SIMBRINZA safely and effectively. See full prescribing information for SIMBRINZA. SIMBRINZA (brinzolamide and brimonidine tartrate ophthalmic suspension) 1%/0.2%, for topical ophthalmic use Initial U.S. Approval: 2013
Approved
Approval ID
a49c157e-6310-0011-7b7f-e26fc1820d59
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 16, 2023
Manufacturers
FDA
Alcon Laboratories, Inc.
DUNS: 008018525
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
brinzolamide/brimonidine tartrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0065-4147
Application NumberNDA204251
Product Classification
M
Marketing Category
C73594
G
Generic Name
brinzolamide/brimonidine tartrate
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateMay 16, 2023
FDA Product Classification
INGREDIENTS (12)
BrinzolamideActive
Quantity: 10 mg in 1 mL
Code: 9451Z89515
Classification: ACTIB
Brimonidine TartrateActive
Quantity: 2 mg in 1 mL
Code: 4S9CL2DY2H
Classification: ACTIB
MannitolInactive
Code: 3OWL53L36A
Classification: IACT
Benzalkonium ChlorideInactive
Code: F5UM2KM3W7
Classification: IACT
Carbomer Homopolymer Type B (allyl Pentaerythritol Crosslinked)Inactive
Code: HHT01ZNK31
Classification: IACT
Boric AcidInactive
Code: R57ZHV85D4
Classification: IACT
Propylene GlycolInactive
Code: 6DC9Q167V3
Classification: IACT
Sodium ChlorideInactive
Code: 451W47IQ8X
Classification: IACT
TyloxapolInactive
Code: Y27PUL9H56
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT
Hydrochloric AcidInactive
Code: QTT17582CB
Classification: IACT
Sodium HydroxideInactive
Code: 55X04QC32I
Classification: IACT