Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution

Orange BookUNIISPLATC S01EC

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

Identification

ManufacturerAlembic Pharmaceuticals Limited

CountryUS (United States)

ATC codeS01EC

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
4670855310
1 BOTTLE in 1 CARTON (46708-553-10) / 10 mL in 1 BOTTLE

Annotations

UNII (FDA Substance ID)

QZO5366EW7

DORZOLAMIDE HYDROCHLORIDE

RxCUI 236065

Orange Book

A213099

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": "46708-553_2b1fa44a-3890-4634-bcfc-c7310b51128e",
  "productndc": "46708-553",
  "dosage_form": "SOLUTION/ DROPS",
  "orange_book": {
    "appl_no": "213099",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AT1",
        "strength": "EQ 2% BASE;EQ 0.5% BASE",
        "product_no": "001",
        "approval_date": "May 4, 2021"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE",
  "proprietary_name": "Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution",
  "active_ingred_unit": "mg/mL; mg/mL",
  "application_number": "ANDA213099",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution",
  "start_marketing_date": "20210504",
  "active_numerator_strength": "20; 5"
}

Related drugs

Other records sharing ATC code S01EC.

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