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United States · US · US:14445-404_746e0cc7-7ea7-4090-acb3-69de5fe85be3

Dorzolamide Hydrochloride

Orange BookUNIISPLATC S01EC03

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

Identification

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

Packs · 1

  • ndc11
    1444540410
    1 BOTTLE, DISPENSING in 1 CARTON (14445-404-10) / 10 mL in 1 BOTTLE, DISPENSING

Annotations

UNII (FDA Substance ID)
QZO5366EW7
DORZOLAMIDE HYDROCHLORIDE
RxCUI 236065
Orange Book
A202053
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": "14445-404_746e0cc7-7ea7-4090-acb3-69de5fe85be3",
  "productndc": "14445-404",
  "dosage_form": "SOLUTION/ DROPS",
  "orange_book": {
    "appl_no": "202053",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AT",
        "strength": "EQ 2% BASE",
        "product_no": "001",
        "approval_date": "Sep 11, 2014"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DORZOLAMIDE HYDROCHLORIDE",
  "proprietary_name": "Dorzolamide Hydrochloride",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA202053",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Dorzolamide",
  "start_marketing_date": "20210514",
  "active_numerator_strength": "20"
}

Related drugs

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