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United States · US · US:65862-947_62486059-bf52-4bd3-b902-a1423c9bf649

Dorzolamide Hydrochloride and Timolol Maleate Preservative Free

Orange BookUNIISPLATC S01EC

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

Identification

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

Packs · 2

  • ndc11
    6586294718
    12 POUCH in 1 CARTON (65862-947-18) / 15 VIAL, SINGLE-USE in 1 POUCH / .2 mL in 1 VIAL, SINGLE-USE
  • ndc11
    6586294760
    4 POUCH in 1 CARTON (65862-947-60) / 15 VIAL, SINGLE-USE in 1 POUCH (65862-947-15) / .2 mL in 1 VIAL, SINGLE-USE

Annotations

UNII (FDA Substance ID)
QZO5366EW7
DORZOLAMIDE HYDROCHLORIDE
RxCUI 236065
Orange Book
A207630
AT2
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": "65862-947_62486059-bf52-4bd3-b902-a1423c9bf649",
  "productndc": "65862-947",
  "dosage_form": "SOLUTION/ DROPS",
  "orange_book": {
    "appl_no": "207630",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AT2",
        "strength": "EQ 2% BASE;EQ 0.5% BASE",
        "product_no": "001",
        "approval_date": "Jul 24, 2018"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE",
  "proprietary_name": "Dorzolamide Hydrochloride and Timolol Maleate Preservative Free",
  "active_ingred_unit": "mg/mL; mg/mL",
  "application_number": "ANDA207630",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Dorzolamide Hydrochloride and Timolol Maleate Preservative Free",
  "start_marketing_date": "20180724",
  "active_numerator_strength": "20; 5"
}

Related drugs

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