🇺🇸
United States · US · US:82667-200_515542b6-cc36-ff77-e063-6294a90ad59e
IOPIDINE 1%
Orange BookUNIISPLATC S01EA03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerHarrow Eye, LLC
CountryUS (United States)
ATC codeS01EA03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11826672000112 POUCH in 1 CARTON (82667-200-01) / 2 VIAL, SINGLE-DOSE in 1 POUCH / .1 mL in 1 VIAL, SINGLE-DOSE
- ndc1182667200055 POUCH in 1 CARTON (82667-200-05) / 5 VIAL, SINGLE-DOSE in 1 POUCH / .1 mL in 1 VIAL, SINGLE-DOSE
Annotations
UNII (FDA Substance ID)
D2VW67N38H
APRACLONIDINE HYDROCHLORIDE
RxCUI 91350
Orange Book
N019779
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": {
"00f18845-ccde-8678-e063-6294a90a3374": {
"match": "brand_token",
"title": "IOPIDINE 1% (APRACLONIDINE HYDROCHLORIDE OPHTHALMIC SOLUTION) SOLUTION/ DROPS [HARROW EYE, LLC]",
"spl_version": "4",
"published_date": "2026-05-11"
}
},
"productid": "82667-200_515542b6-cc36-ff77-e063-6294a90ad59e",
"productndc": "82667-200",
"dosage_form": "SOLUTION/ DROPS",
"orange_book": {
"appl_no": "019779",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "EQ 1% BASE",
"product_no": "001",
"approval_date": "Dec 31, 1987"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "APRACLONIDINE HYDROCHLORIDE",
"proprietary_name": "IOPIDINE 1%",
"active_ingred_unit": "mg/mL",
"application_number": "NDA019779",
"marketing_category": "NDA",
"nonproprietary_name": "apraclonidine hydrochloride ophthalmic solution",
"start_marketing_date": "20230801",
"active_numerator_strength": "10"
}Related drugs
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- 🇨🇭Iopidine
- DKIopidineEssential Pharma Limited
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