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United States · US · US:82667-014_4dc90c49-5f0b-50de-e063-6394a90a301c

Verkazia

Orange BookUNIISPLATC S01XA18

Last synced from FDA National Drug Code directory (United States) on

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
    8266701400
    5 POUCH in 1 CARTON (82667-014-00) / 5 VIAL, SINGLE-DOSE in 1 POUCH / .3 mL in 1 VIAL, SINGLE-DOSE
  • ndc11
    8266701401
    24 POUCH in 1 CARTON (82667-014-01) / 5 VIAL, SINGLE-DOSE in 1 POUCH / .3 mL in 1 VIAL, SINGLE-DOSE

Annotations

UNII (FDA Substance ID)
83HN0GTJ6D
CYCLOSPORINE
RxCUI 3008
Orange Book
N214965
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; TOPICAL",
  "spl_meta": {
    "48651d30-9e6e-74b0-e063-6294a90a8337": {
      "match": "brand_token",
      "title": "VERKAZIA (CYCLOSPORINE) EMULSION [HARROW EYE, LLC]",
      "spl_version": "4",
      "published_date": "2026-03-26"
    }
  },
  "productid": "82667-014_4dc90c49-5f0b-50de-e063-6394a90a301c",
  "productndc": "82667-014",
  "dosage_form": "EMULSION",
  "orange_book": {
    "appl_no": "214965",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "0.1%",
        "product_no": "001",
        "approval_date": "Jun 23, 2021"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CYCLOSPORINE",
  "proprietary_name": "Verkazia",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA214965",
  "marketing_category": "NDA",
  "nonproprietary_name": "cyclosporine",
  "start_marketing_date": "20220201",
  "active_numerator_strength": "1"
}

Related drugs

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