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United States · US · US:61314-665_238af96f-2f89-9af4-e063-6394a90a9516
Apraclonidine
Orange BookUNIISPLATC S01EA03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSandoz Inc
CountryUS (United States)
ATC codeS01EA03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1161314665055 mL in 1 BOTTLE (61314-665-05)
- ndc11613146651010 mL in 1 BOTTLE (61314-665-10)
Annotations
UNII (FDA Substance ID)
D2VW67N38H
APRACLONIDINE HYDROCHLORIDE
RxCUI 91350
Orange Book
N020258
AT
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "D2VW67N38H",
"rxcui": "91350",
"inchikey": "OTQYGBJVDRBCHC-UHFFFAOYSA-N",
"display_name": "APRACLONIDINE HYDROCHLORIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "OPHTHALMIC",
"spl_meta": {
"04ad82af-e7ba-4f40-a120-be9d33cf0c7b": {
"match": "brand_token",
"title": "APRACLONIDINE SOLUTION [SANDOZ INC]",
"spl_version": "8",
"published_date": "2024-10-09"
}
},
"productid": "61314-665_238af96f-2f89-9af4-e063-6394a90a9516",
"productndc": "61314-665",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "020258",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AT",
"strength": "EQ 0.5% BASE",
"product_no": "001",
"approval_date": "Jul 30, 1993"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "APRACLONIDINE HYDROCHLORIDE",
"proprietary_name": "Apraclonidine",
"active_ingred_unit": "mg/mL",
"application_number": "NDA020258",
"marketing_category": "NDA AUTHORIZED GENERIC",
"nonproprietary_name": "Apraclonidine",
"start_marketing_date": "20090719",
"active_numerator_strength": "5.75"
}Related drugs
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