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United States · US · US:69315-305_bb4ef754-0b95-4c0e-8131-7a81dc4f33d3

Dorzolamide and Timolol

Orange BookUNIISPLATC S01EC

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

Identification

ManufacturerLeading Pharma, LLC
CountryUS (United States)
ATC codeS01EC
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    6931530505
    1 BOTTLE, PLASTIC in 1 CARTON (69315-305-05) / 5 mL in 1 BOTTLE, PLASTIC
  • ndc11
    6931530510
    1 BOTTLE, PLASTIC in 1 CARTON (69315-305-10) / 10 mL in 1 BOTTLE, PLASTIC

Annotations

UNII (FDA Substance ID)
QZO5366EW7
DORZOLAMIDE HYDROCHLORIDE
RxCUI 236065
Orange Book
A205295
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": "69315-305_bb4ef754-0b95-4c0e-8131-7a81dc4f33d3",
  "productndc": "69315-305",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "205295",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AT1",
        "strength": "EQ 2% BASE;EQ 0.5% BASE",
        "product_no": "001",
        "approval_date": "Jun 13, 2019"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE",
  "proprietary_name": "Dorzolamide and Timolol",
  "active_ingred_unit": "mg/mL; mg/mL",
  "application_number": "ANDA205295",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution",
  "start_marketing_date": "20170518",
  "active_numerator_strength": "20; 5"
}

Related drugs

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