brinzolamide

Generic: brinzolamide

Labeler: padagis us llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name brinzolamide
Generic Name brinzolamide
Labeler padagis us llc
Dosage Form SUSPENSION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

brinzolamide 10 mg/mL

Manufacturer
Padagis US LLC

Identifiers & Regulatory

Product NDC 0574-4012
Product ID 0574-4012_071072b1-f9f8-4267-aa04-848d27e0e902
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211914
Listing Expiration 2026-12-31
Marketing Start 2023-10-10

Pharmacologic Class

Established (EPC)
carbonic anhydrase inhibitor [epc]
Mechanism of Action
carbonic anhydrase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 05744012
Hyphenated Format 0574-4012

Supplemental Identifiers

RxCUI
308805
UNII
9451Z89515
NUI
N0000175517 N0000000235

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name brinzolamide (source: ndc)
Generic Name brinzolamide (source: ndc)
Application Number ANDA211914 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (0574-4012-10) / 10 mL in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (0574-4012-15) / 15 mL in 1 BOTTLE
source: ndc

Packages (2)

0574-4012-10 1 BOTTLE in 1 CARTON (0574-4012-10) / 10 mL in 1 BOTTLE 0574-4012-15 1 BOTTLE in 1 CARTON (0574-4012-15) / 15 mL in 1 BOTTLE

Ingredients (1)

brinzolamide (10 mg/mL)

Linked Drug Pages (1)

BRINZOLAMIDE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "071072b1-f9f8-4267-aa04-848d27e0e902", "openfda": {"nui": ["N0000175517", "N0000000235"], "unii": ["9451Z89515"], "rxcui": ["308805"], "spl_set_id": ["b56a2e4b-7502-4831-a5b1-0370bdb987b1"], "pharm_class_epc": ["Carbonic Anhydrase Inhibitor [EPC]"], "pharm_class_moa": ["Carbonic Anhydrase Inhibitors [MoA]"], "manufacturer_name": ["Padagis US LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (0574-4012-10)  / 10 mL in 1 BOTTLE", "package_ndc": "0574-4012-10", "marketing_start_date": "20231010"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (0574-4012-15)  / 15 mL in 1 BOTTLE", "package_ndc": "0574-4012-15", "marketing_start_date": "20231010"}], "brand_name": "BRINZOLAMIDE", "product_id": "0574-4012_071072b1-f9f8-4267-aa04-848d27e0e902", "dosage_form": "SUSPENSION/ DROPS", "pharm_class": ["Carbonic Anhydrase Inhibitor [EPC]", "Carbonic Anhydrase Inhibitors [MoA]"], "product_ndc": "0574-4012", "generic_name": "brinzolamide", "labeler_name": "Padagis US LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "BRINZOLAMIDE", "active_ingredients": [{"name": "BRINZOLAMIDE", "strength": "10 mg/mL"}], "application_number": "ANDA211914", "marketing_category": "ANDA", "marketing_start_date": "20231010", "listing_expiration_date": "20261231"}