Back to search
🇺🇸

United States · US · US:46708-519_64e77f0a-fff5-4e24-9af2-38a14b9a4ef9

Dorzolamide Hydrochloride

Orange BookUNIISPLATC S01EC03

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

Identification

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

Packs · 1

  • ndc11
    4670851910
    1 BOTTLE in 1 CARTON (46708-519-10) / 10 mL in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
QZO5366EW7
DORZOLAMIDE HYDROCHLORIDE
RxCUI 236065
Orange Book
A212639
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": "46708-519_64e77f0a-fff5-4e24-9af2-38a14b9a4ef9",
  "productndc": "46708-519",
  "dosage_form": "SOLUTION/ DROPS",
  "orange_book": {
    "appl_no": "212639",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AT",
        "strength": "EQ 2% BASE",
        "product_no": "001",
        "approval_date": "Aug 9, 2019"
      }
    ],
    "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": "ANDA212639",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Dorzolamide Hydrochloride",
  "start_marketing_date": "20190809",
  "active_numerator_strength": "20"
}

Related drugs

Other records sharing ATC code S01EC03.

Access this data programmatically

Query Dorzolamide Hydrochloride and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.