azopt

Generic: brinzolamide

Labeler: sandoz inc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name azopt
Generic Name brinzolamide
Labeler sandoz inc
Dosage Form SUSPENSION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

brinzolamide 10 mg/mL

Manufacturer
Sandoz Inc

Identifiers & Regulatory

Product NDC 66758-085
Product ID 66758-085_0afb6589-51ba-432c-aed1-20a12d5d3455
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA020816
Listing Expiration 2026-12-31
Marketing Start 1998-04-30

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 66758085
Hyphenated Format 66758-085

Supplemental Identifiers

RxCUI
213272 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 azopt (source: ndc)
Generic Name brinzolamide (source: ndc)
Application Number NDA020816 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (66758-085-70) / 10 mL in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (66758-085-85) / 15 mL in 1 BOTTLE
source: ndc

Packages (2)

66758-085-70 1 BOTTLE in 1 CARTON (66758-085-70) / 10 mL in 1 BOTTLE 66758-085-85 1 BOTTLE in 1 CARTON (66758-085-85) / 15 mL in 1 BOTTLE

Ingredients (1)

brinzolamide (10 mg/mL)

Linked Drug Pages (1)

Azopt ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "0afb6589-51ba-432c-aed1-20a12d5d3455", "openfda": {"nui": ["N0000175517", "N0000000235"], "unii": ["9451Z89515"], "rxcui": ["213272", "308805"], "spl_set_id": ["0afb6589-51ba-432c-aed1-20a12d5d3455"], "pharm_class_epc": ["Carbonic Anhydrase Inhibitor [EPC]"], "pharm_class_moa": ["Carbonic Anhydrase Inhibitors [MoA]"], "manufacturer_name": ["Sandoz Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (66758-085-70)  / 10 mL in 1 BOTTLE", "package_ndc": "66758-085-70", "marketing_start_date": "20241025"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (66758-085-85)  / 15 mL in 1 BOTTLE", "package_ndc": "66758-085-85", "marketing_start_date": "20241115"}], "brand_name": "Azopt", "product_id": "66758-085_0afb6589-51ba-432c-aed1-20a12d5d3455", "dosage_form": "SUSPENSION/ DROPS", "pharm_class": ["Carbonic Anhydrase Inhibitor [EPC]", "Carbonic Anhydrase Inhibitors [MoA]"], "product_ndc": "66758-085", "generic_name": "brinzolamide", "labeler_name": "Sandoz Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Azopt", "active_ingredients": [{"name": "BRINZOLAMIDE", "strength": "10 mg/mL"}], "application_number": "NDA020816", "marketing_category": "NDA", "marketing_start_date": "19980430", "listing_expiration_date": "20261231"}