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United States · US · US:82292-040_8a6aec36-4e75-4cd0-a250-cb126128bbd4

LUMISIGHT

Orange BookUNIISPL

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

Identification

ManufacturerLumicell, Inc.
CountryUS (United States)
ATC code
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    8229204010
    10 VIAL in 1 CARTON (82292-040-10) / 3.9 mL in 1 VIAL (82292-040-01)

Annotations

UNII (FDA Substance ID)
T6HE85WN0Q
PEGULICIANINE
Orange Book
N214511
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "T6HE85WN0Q",
    "rxcui": null,
    "inchikey": null,
    "display_name": "PEGULICIANINE",
    "substance_type": "polymer",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "7160e774-663a-43e4-ba4a-06cc57830e66": {
      "match": "brand_token",
      "title": "LUMISIGHT (PEGULICIANINE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [LUMICELL, INC.]",
      "spl_version": "3",
      "published_date": "2026-01-12"
    }
  },
  "productid": "82292-040_8a6aec36-4e75-4cd0-a250-cb126128bbd4",
  "productndc": "82292-040",
  "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
  "orange_book": {
    "appl_no": "214511",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 39MG BASE/VIAL",
        "product_no": "001",
        "approval_date": "Apr 17, 2024"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PEGULICIANINE",
  "proprietary_name": "LUMISIGHT",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA214511",
  "marketing_category": "NDA",
  "nonproprietary_name": "Pegulicianine",
  "start_marketing_date": "20240417",
  "active_numerator_strength": "10"
}

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