COSOPT

Orange BookUNIISPLATC S01EC

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerThea Pharma Inc.

CountryUS (United States)

ATC codeS01EC

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
8258460510
1 BOTTLE, DROPPER in 1 CARTON (82584-605-10) / 10 mL in 1 BOTTLE, DROPPER

Annotations

UNII (FDA Substance ID)

QZO5366EW7

DORZOLAMIDE HYDROCHLORIDE

RxCUI 236065

Orange Book

N020869

AT1

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "QZO5366EW7",
    "rxcui": "236065",
    "inchikey": "OSRUSFPMRGDLAG-QMGYSKNISA-N",
    "display_name": "DORZOLAMIDE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "OPHTHALMIC",
  "spl_meta": {
    "535fc801-8c3f-4974-a120-3eff1d5a5062": {
      "match": "brand_token",
      "title": "COSOPT PF (DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE) SOLUTION/ DROPS [THEA PHARMA INC.]",
      "spl_version": "5",
      "published_date": "2026-05-15"
    }
  },
  "productid": "82584-605_164c0ca8-87af-0887-e063-6294a90a5ec7",
  "productndc": "82584-605",
  "dosage_form": "SOLUTION/ DROPS",
  "orange_book": {
    "appl_no": "020869",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AT1",
        "strength": "EQ 2% BASE;EQ 0.5% BASE",
        "product_no": "001",
        "approval_date": "Apr 7, 1998"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE",
  "proprietary_name": "COSOPT",
  "active_ingred_unit": "mg/mL; mg/mL",
  "application_number": "NDA020869",
  "marketing_category": "NDA",
  "nonproprietary_name": "dorzolamide hydrochloride and timolol maleate",
  "start_marketing_date": "20221110",
  "active_numerator_strength": "20; 5"
}

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