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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%, for topical ophthalmic useInitial U.S. Approval: 1998

Approved
Approval ID

460baf5f-1d47-4ae0-b635-84507c3b028d

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Dec 19, 2023

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

NDC Product Code72162-2201
Application NumberANDA211914
Marketing CategoryC73584
Route of AdministrationOPHTHALMIC
Effective DateDecember 19, 2023
Generic Namebrinzolamide

INGREDIENTS (10)

BRINZOLAMIDEActive
Quantity: 10 mg in 1 mL
Code: 9451Z89515
Classification: ACTIB
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
TYLOXAPOLInactive
Code: Y27PUL9H56
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
BENZALKONIUM CHLORIDEInactive
Quantity: 0.1 mg in 1 mL
Code: F5UM2KM3W7
Classification: IACT
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)Inactive
Code: HHT01ZNK31
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT

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BRINZOLAMIDE - FDA Drug Approval Details