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United States · US · US:69315-304_74ba8267-62eb-4b2e-a349-400d998a8eb8
Dorzolamide hydrochloride
Orange BookUNIISPLATC S01EC03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerLeading Pharma, LLC
CountryUS (United States)
ATC codeS01EC03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1169315304051 BOTTLE in 1 CARTON (69315-304-05) / 5 mL in 1 BOTTLE
- ndc1169315304101 BOTTLE in 1 CARTON (69315-304-10) / 10 mL in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
QZO5366EW7
DORZOLAMIDE HYDROCHLORIDE
RxCUI 236065
Orange Book
A205294
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": "69315-304_74ba8267-62eb-4b2e-a349-400d998a8eb8",
"productndc": "69315-304",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "205294",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AT",
"strength": "EQ 2% BASE",
"product_no": "001",
"approval_date": "Jan 24, 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": "ANDA205294",
"marketing_category": "ANDA",
"nonproprietary_name": "Dorzolamide hydrochloride",
"start_marketing_date": "20191201",
"active_numerator_strength": "20"
}Related drugs
Other records sharing ATC code S01EC03.
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