Brinzolamide
These highlights do not include all the information needed to use BRINZOLAMIDE OPHTHALMIC SUSPENSION safely and effectively. See full prescribing information for BRINZOLAMIDE OPHTHALMIC SUSPENSION. BRINZOLAMIDE ophthalmic suspension 1% Sterile topical ophthalmic drops Initial U.S. Approval: 1998
Approved
Approval ID
cd9837a8-5c50-4343-8f66-b8c6403a6f0d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 11, 2024
Manufacturers
FDA
Bryant Ranch Prepack
DUNS: 171714327
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Brinzolamide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63629-8793
Application NumberNDA020816
Product Classification
M
Marketing Category
C73605
G
Generic Name
Brinzolamide
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateSeptember 10, 2021
FDA Product Classification
INGREDIENTS (10)
BRINZOLAMIDEActive
Quantity: 10 mg in 1 mL
Code: 9451Z89515
Classification: ACTIB
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
TYLOXAPOLInactive
Code: Y27PUL9H56
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)Inactive
Code: 4Q93RCW27E
Classification: IACT
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT