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United States · US · US:69315-305_bb4ef754-0b95-4c0e-8131-7a81dc4f33d3
Dorzolamide and Timolol
Orange BookUNIISPLATC S01EC
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerLeading Pharma, LLC
CountryUS (United States)
ATC codeS01EC
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1169315305051 BOTTLE, PLASTIC in 1 CARTON (69315-305-05) / 5 mL in 1 BOTTLE, PLASTIC
- ndc1169315305101 BOTTLE, PLASTIC in 1 CARTON (69315-305-10) / 10 mL in 1 BOTTLE, PLASTIC
Annotations
UNII (FDA Substance ID)
QZO5366EW7
DORZOLAMIDE HYDROCHLORIDE
RxCUI 236065
Orange Book
A205295
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": "69315-305_bb4ef754-0b95-4c0e-8131-7a81dc4f33d3",
"productndc": "69315-305",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "205295",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AT1",
"strength": "EQ 2% BASE;EQ 0.5% BASE",
"product_no": "001",
"approval_date": "Jun 13, 2019"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE",
"proprietary_name": "Dorzolamide and Timolol",
"active_ingred_unit": "mg/mL; mg/mL",
"application_number": "ANDA205295",
"marketing_category": "ANDA",
"nonproprietary_name": "Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution",
"start_marketing_date": "20170518",
"active_numerator_strength": "20; 5"
}Related drugs
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