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United States· US:71921-226_3b805f74-957a-4a13-8066-94aed2ed4f10

DORZOLAMIDE HYDROCHLORIDE TIMOLOL MALEATE

A carbonic anhydrase inhibitors product containing dorzolamide hydrochloride timolol maleate, registered in United States by Florida Pharmaceutical Products, LLC.

ATC S01ECOrange BookUS label

Checked against FDA National Drug Code directory (United States) on

Informational only — not a medical device.

SOURCE REGISTER · USFDA National Drug Code directory (Unite…normalisedDORZOLAMIDE HYDROCHLORIDE TIMOLOL MAL…ATCS01ECREGISTER NO.US:71921-226_3b805f74…PACKS LISTED1CHECKEDJune 3, 2026

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
dorzolamide hydrochloride timolol maleate
Manufacturer
Florida Pharmaceutical Products, LLC
Country
United States (US)
ATC code
S01EC
ATC class
Carbonic anhydrase inhibitors
Reimbursed
Not published by this register
Source register
FDA National Drug Code directory (United States)
Last checked
June 3, 2026

Packs & prices · 1

  • ndc11
    7192122610
    1 BOTTLE, DISPENSING in 1 CARTON (71921-226-10) / 10 mL in 1 BOTTLE, DISPENSING

Regulatory notes

UNII (FDA substance ID)
QZO5366EW7
DORZOLAMIDE HYDROCHLORIDE
RxCUI 236065
Orange Book
A202054
AT1
DailyMed SPL labels
1 version tracked

Sourced from a public register and reproduced with attribution. Drug Database is not affiliated with, endorsed by, or a partner of FDA National Drug Code directory (United States). This is an informational data service and not a medical device — verify against the official source of record before any clinical decision.

For developers

The same record over the API, and the raw payload
GET /v1/drugs/bc874aa8-f9e9-429c-b6ee-c90764f1edcb
GET /v1/drugs/bc874aa8-f9e9-429c-b6ee-c90764f1edcb?format=fhir

Every response carries last_synced_at, so freshness is a field rather than a promise. Below is exactly what the ingestion wrote, before any presentation — the same JSON the API returns under payload.

{
  "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": "71921-226_3b805f74-957a-4a13-8066-94aed2ed4f10",
  "productndc": "71921-226",
  "dosage_form": "SOLUTION/ DROPS",
  "orange_book": {
    "appl_no": "202054",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AT1",
        "strength": "EQ 2% BASE;EQ 0.5% BASE",
        "product_no": "001",
        "approval_date": "Sep 3, 2014"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE",
  "proprietary_name": "DORZOLAMIDE HYDROCHLORIDE TIMOLOL MALEATE",
  "active_ingred_unit": "mg/mL; mg/mL",
  "application_number": "ANDA202054",
  "marketing_category": "ANDA",
  "nonproprietary_name": "dorzolamide hydrochloride timolol maleate",
  "start_marketing_date": "20230816",
  "active_numerator_strength": "20; 5"
}

See everything about dorzolamide hydrochloride timolol maleate.

This page is the registration. A free account adds the label text as the regulator wrote it, what it costs per daily dose across the markets that publish a price, a feed of what changes in the registers, and an assistant that answers with its sources. Interaction severity is free; mechanism and management are on the Growth plan. No card, nothing to install.