Verkazia

Orange BookUNIISPLATC S01XA18

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

Identification

ManufacturerSanten Incorporated

CountryUS (United States)

ATC codeS01XA18

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
6508600105
1 POUCH in 1 CARTON (65086-001-05) / 5 VIAL, SINGLE-DOSE in 1 POUCH / .3 mL in 1 VIAL, SINGLE-DOSE
ndc11
6508600112
24 POUCH in 1 CARTON (65086-001-12) / 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": "65086-001_2becea0d-7cbe-6b23-e063-6294a90a5a67",
  "productndc": "65086-001",
  "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

Other records sharing ATC code S01XA18.

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