VEVYE

Orange BookUNIISPLATC S01XA18

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerHarrow Eye, LLC

CountryUS (United States)

ATC codeS01XA18

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
8266790000
1 BOTTLE, DROPPER in 1 CARTON (82667-900-00) / 2 mL in 1 BOTTLE, DROPPER
ndc11
8266790002
1 BOTTLE, DROPPER in 1 CARTON (82667-900-02) / 2 mL in 1 BOTTLE, DROPPER

Annotations

UNII (FDA Substance ID)

83HN0GTJ6D

CYCLOSPORINE

RxCUI 3008

Orange Book

N217469

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "83HN0GTJ6D",
    "rxcui": "3008",
    "inchikey": "PMATZTZNYRCHOR-CGLBZJNRSA-N",
    "display_name": "CYCLOSPORINE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "OPHTHALMIC",
  "spl_meta": {
    "0a60fccf-7e1b-44fe-e063-6394a90aadd5": {
      "match": "brand_token",
      "title": "VEVYE (CYCLOSPORINE OPHTHALMIC SOLUTION) SOLUTION/ DROPS [HARROW EYE, LLC]",
      "spl_version": "4",
      "published_date": "2026-03-02"
    }
  },
  "productid": "82667-900_4bc25aeb-44ca-06b2-e063-6294a90a03c0",
  "productndc": "82667-900",
  "dosage_form": "SOLUTION/ DROPS",
  "orange_book": {
    "appl_no": "217469",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "0.1%",
        "product_no": "001",
        "approval_date": "May 30, 2023"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CYCLOSPORINE",
  "proprietary_name": "VEVYE",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA217469",
  "marketing_category": "NDA",
  "nonproprietary_name": "cyclosporine ophthalmic solution",
  "start_marketing_date": "20231201",
  "active_numerator_strength": "1"
}

Related drugs

Other records sharing ATC code S01XA18.

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