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United States · US · US:82667-500_42dbdcfd-3edd-46a3-e063-6394a90ac694
NEVANAC
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
- ndc1182667500031 BOTTLE, PLASTIC in 1 CARTON (82667-500-03) / 3 mL in 1 BOTTLE, PLASTIC
Annotations
UNII (FDA Substance ID)
0J9L7J6V8C
NEPAFENAC
RxCUI 298665
Orange Book
N021862
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": {
"11b9a0cf-2a70-17ef-e063-6394a90a5d9e": {
"match": "brand_token",
"title": "NEVANAC (NEPAFENAC) SUSPENSION/ DROPS [HARROW EYE, LLC]",
"spl_version": "3",
"published_date": "2025-11-17"
}
},
"productid": "82667-500_42dbdcfd-3edd-46a3-e063-6394a90ac694",
"productndc": "82667-500",
"dosage_form": "SUSPENSION/ DROPS",
"orange_book": {
"appl_no": "021862",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "0.1%",
"product_no": "001",
"approval_date": "Aug 19, 2005"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "NEPAFENAC",
"proprietary_name": "NEVANAC",
"active_ingred_unit": "mg/mL",
"application_number": "NDA021862",
"marketing_category": "NDA",
"nonproprietary_name": "nepafenac",
"start_marketing_date": "20250101",
"active_numerator_strength": "1"
}Related drugs
Other records sharing ATC code S01BC10.
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