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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 Initial U.S. Approval: 1998

Approved
Approval ID

ec29d07f-99ac-45ed-af0a-d9b7d1a8c032

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jul 21, 2023

Manufacturers
FDA

Actavis Pharma, Inc.

DUNS: 119723554

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 Code0591-2127
Application NumberANDA209406
Product Classification
M
Marketing Category
C73584
G
Generic Name
Brinzolamide
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateJuly 21, 2023
FDA Product Classification

INGREDIENTS (10)

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

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