Dorzolamide Hydrochloride and Timolol Maleate

Orange BookUNIISPLATC S01EC

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

Identification

ManufacturerAkorn

CountryUS (United States)

ATC codeS01EC

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 0

No packs registered.

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": {
    "ff76c0cf-256c-4015-94f4-405f0c46205f": {
      "match": "brand_token",
      "title": "DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE SOLUTION/ DROPS [BRYANT RANCH PREPACK]",
      "spl_version": "101",
      "published_date": "2026-05-04"
    }
  },
  "productid": "50383-261_5c6a634a-b5ed-417d-b4b9-bc389538f59d",
  "productndc": "50383-261",
  "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": "Dorzolamide Hydrochloride and Timolol Maleate",
  "active_ingred_unit": "mg/mL; mg/mL",
  "application_number": "NDA202667",
  "marketing_category": "NDA",
  "nonproprietary_name": "Dorzolamide Hydrochloride and Timolol Maleate",
  "start_marketing_date": "20190201",
  "active_numerator_strength": "20; 5"
}

Related drugs

Other records sharing ATC code S01EC.

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