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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

  • ndc11
    8266740003
    1 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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