🇺🇸
United States · US · US:82667-400_4e6f184f-0de5-acca-e063-6394a90ac321
ILEVRO
Orange BookUNIISPLATC S01BC10
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerHarrow Eye, LLC
CountryUS (United States)
ATC codeS01BC10
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1182667400031 BOTTLE, PLASTIC in 1 CARTON (82667-400-03) / 3 mL in 1 BOTTLE, PLASTIC
Annotations
UNII (FDA Substance ID)
0J9L7J6V8C
NEPAFENAC
RxCUI 298665
Orange Book
N203491
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "0J9L7J6V8C",
"rxcui": "298665",
"inchikey": "QEFAQIPZVLVERP-UHFFFAOYSA-N",
"display_name": "NEPAFENAC",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "OPHTHALMIC",
"spl_meta": {
"10f411d3-a81e-074a-e063-6294a90ab547": {
"match": "brand_token",
"title": "ILEVRO (NEPAFENAC) SUSPENSION/ DROPS [HARROW EYE, LLC]",
"spl_version": "5",
"published_date": "2026-04-03"
}
},
"productid": "82667-400_4e6f184f-0de5-acca-e063-6394a90ac321",
"productndc": "82667-400",
"dosage_form": "SUSPENSION/ DROPS",
"orange_book": {
"appl_no": "203491",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "0.3%",
"product_no": "001",
"approval_date": "Oct 16, 2012"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "NEPAFENAC",
"proprietary_name": "ILEVRO",
"active_ingred_unit": "mg/mL",
"application_number": "NDA203491",
"marketing_category": "NDA",
"nonproprietary_name": "nepafenac",
"start_marketing_date": "20240501",
"active_numerator_strength": "3"
}Related drugs
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- PLNevanacNovartis Europharm Limited
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- 🇨🇭NevanacNovartis Pharma Schweiz AG
- ISNevanacNovartis Europharm Limited*
- NONevanacNovartis Europharm Limited (1)
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