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United States · US · US:66758-085_0afb6589-51ba-432c-aed1-20a12d5d3455

Azopt

Orange BookUNIISPLATC S01EC04

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerSandoz Inc
CountryUS (United States)
ATC codeS01EC04
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    6675808570
    1 BOTTLE in 1 CARTON (66758-085-70) / 10 mL in 1 BOTTLE
  • ndc11
    6675808585
    1 BOTTLE in 1 CARTON (66758-085-85) / 15 mL in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
9451Z89515
BRINZOLAMIDE
RxCUI 194881
Orange Book
N020816
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "9451Z89515",
    "rxcui": "194881",
    "inchikey": "HCRKCZRJWPKOAR-JTQLQIEISA-N",
    "display_name": "BRINZOLAMIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "OPHTHALMIC",
  "spl_meta": {
    "0afb6589-51ba-432c-aed1-20a12d5d3455": {
      "match": "brand_token",
      "title": "AZOPT (BRINZOLAMIDE) SUSPENSION/ DROPS [SANDOZ INC]",
      "spl_version": "1",
      "published_date": "2024-10-25"
    }
  },
  "productid": "66758-085_0afb6589-51ba-432c-aed1-20a12d5d3455",
  "productndc": "66758-085",
  "dosage_form": "SUSPENSION/ DROPS",
  "orange_book": {
    "appl_no": "020816",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "1%",
        "product_no": "001",
        "approval_date": "Apr 1, 1998"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "BRINZOLAMIDE",
  "proprietary_name": "Azopt",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA020816",
  "marketing_category": "NDA",
  "nonproprietary_name": "brinzolamide",
  "start_marketing_date": "19980430",
  "active_numerator_strength": "10"
}

Related drugs

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