Dorzolamide Hydrochloride and Timolol Maleate

Orange BookUNIISPLATC S01EC

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

Identification

ManufacturerA-S Medication Solutions

CountryUS (United States)

ATC codeS01EC

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5009063710
1 BOTTLE, DROPPER in 1 CARTON (50090-6371-0) / 10 mL in 1 BOTTLE, DROPPER

Annotations

UNII (FDA Substance ID)

QZO5366EW7

DORZOLAMIDE HYDROCHLORIDE

RxCUI 236065

Orange Book

A090037

AT1

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": "50090-6371_0e21f8dd-6fb3-4150-a6c0-a9c20aee8fdf",
  "productndc": "50090-6371",
  "dosage_form": "SOLUTION/ DROPS",
  "orange_book": {
    "appl_no": "090037",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AT1",
        "strength": "EQ 2% BASE;EQ 0.5% BASE",
        "product_no": "001",
        "approval_date": "Jul 14, 2009"
      }
    ],
    "appl_type": "A"
  },
  "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": "ANDA090037",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Dorzolamide Hydrochloride and Timolol Maleate",
  "start_marketing_date": "20090714",
  "active_numerator_strength": "20; 5"
}

Related drugs

Other records sharing ATC code S01EC.

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