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United States · US · US:62332-553_511d4919-0475-4719-8841-a0df9b838b34
Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution
Orange BookUNIISPLATC S01EC
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAlembic Pharmaceuticals Inc.
CountryUS (United States)
ATC codeS01EC
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1162332553101 BOTTLE in 1 CARTON (62332-553-10) / 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": "62332-553_511d4919-0475-4719-8841-a0df9b838b34",
"productndc": "62332-553",
"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
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