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United States · US · US:42571-382_50aa565b-e11f-8176-e063-6294a90ab0b5
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE
Orange BookUNIISPLATC S01EC
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMicro Labs Limited
CountryUS (United States)
ATC codeS01EC
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11425713822712 POUCH in 1 CARTON (42571-382-27) / 15 VIAL, SINGLE-USE in 1 POUCH / .2 mL in 1 VIAL, SINGLE-USE
- ndc1142571382734 POUCH in 1 CARTON (42571-382-73) / 15 VIAL, SINGLE-USE in 1 POUCH (42571-382-71) / .2 mL in 1 VIAL, SINGLE-USE
Annotations
UNII (FDA Substance ID)
QZO5366EW7
DORZOLAMIDE HYDROCHLORIDE
RxCUI 236065
Orange Book
A215936
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": "42571-382_50aa565b-e11f-8176-e063-6294a90ab0b5",
"productndc": "42571-382",
"dosage_form": "SOLUTION/ DROPS",
"orange_book": {
"appl_no": "215936",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AT2",
"strength": "EQ 2% BASE;EQ 0.5% BASE",
"product_no": "001",
"approval_date": "Jan 25, 2022"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE",
"proprietary_name": "DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE",
"active_ingred_unit": "mg/mL; mg/mL",
"application_number": "ANDA215936",
"marketing_category": "ANDA",
"nonproprietary_name": "DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE PRESERVATIVE FREE",
"start_marketing_date": "20220215",
"active_numerator_strength": "20; 5"
}Related drugs
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