COSOPT PF

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
8258460430
4 POUCH in 1 CARTON (82584-604-30) / 15 VIAL, SINGLE-DOSE in 1 POUCH (82584-604-01) / .2 mL in 1 VIAL, SINGLE-DOSE

Annotations

UNII (FDA Substance ID)

QZO5366EW7

DORZOLAMIDE HYDROCHLORIDE

RxCUI 236065

Orange Book

N202667

AT2

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": "82584-604_51b818ee-6194-a845-e063-6394a90ae44b",
  "productndc": "82584-604",
  "dosage_form": "SOLUTION/ DROPS",
  "orange_book": {
    "appl_no": "202667",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AT2",
        "strength": "EQ 2% BASE;EQ 0.5% BASE",
        "product_no": "001",
        "approval_date": "Feb 1, 2012"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE",
  "proprietary_name": "COSOPT PF",
  "active_ingred_unit": "mg/mL; mg/mL",
  "application_number": "NDA202667",
  "marketing_category": "NDA",
  "nonproprietary_name": "dorzolamide hydrochloride and timolol maleate",
  "start_marketing_date": "20221210",
  "active_numerator_strength": "20; 5"
}

Related drugs

Other records sharing ATC code S01EC.

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