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United States · US · US:42571-141_2b30c4d1-0a5d-3ad8-e063-6394a90a4acb

Dorzolamide Hydrochloride Ophthalmic Solution

Orange BookUNIISPLATC S01EC03

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

Identification

ManufacturerMicro Labs Limited
CountryUS (United States)
ATC codeS01EC03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    4257114126
    1 BOTTLE in 1 CARTON (42571-141-26) / 10 mL in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
QZO5366EW7
DORZOLAMIDE HYDROCHLORIDE
RxCUI 236065
Orange Book
A204778
AT
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": "42571-141_2b30c4d1-0a5d-3ad8-e063-6394a90a4acb",
  "productndc": "42571-141",
  "dosage_form": "SOLUTION/ DROPS",
  "orange_book": {
    "appl_no": "204778",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AT",
        "strength": "EQ 2% BASE",
        "product_no": "001",
        "approval_date": "Nov 8, 2019"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DORZOLAMIDE HYDROCHLORIDE",
  "proprietary_name": "Dorzolamide Hydrochloride Ophthalmic Solution",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA204778",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Dorzolamide Hydrochloride",
  "start_marketing_date": "20191111",
  "active_numerator_strength": "20"
}

Related drugs

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