Cysview

Orange BookSPL

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

Identification

ManufacturerPhotocure Inc.

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
1051130012
1 KIT in 1 CARTON (10511-3001-2) * 50 mL in 1 SYRINGE, PLASTIC * 50 mL in 1 VIAL, GLASS

Annotations

Orange Book

N022555

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "route": null,
  "spl_meta": {
    "5aeed40d-6841-4adf-8940-f51d439fdfa3": {
      "match": "brand_token",
      "title": "CYSVIEW (HEXAMINOLEVULINATE HYDROCHLORIDE) KIT [PHOTOCURE INC.]",
      "spl_version": "11",
      "published_date": "2025-12-08"
    }
  },
  "productid": "10511-3001_45327ab1-894f-2a0d-e063-6294a90ab95e",
  "productndc": "10511-3001",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "022555",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "100MG/VIAL",
        "product_no": "001",
        "approval_date": "May 28, 2010"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "Cysview",
  "active_ingred_unit": null,
  "application_number": "NDA022555",
  "marketing_category": "NDA",
  "nonproprietary_name": "Hexaminolevulinate hydrochloride",
  "start_marketing_date": "20180501",
  "active_numerator_strength": null
}

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