Back to search
🇺🇸

United States · US · US:81052-138_4cc23694-63af-f9f1-e063-6394a90a4ce0

Cytalux

Orange BookUNIISPLATC V04CX10

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

Identification

ManufacturerOn Target Laboratories, Inc.
CountryUS (United States)
ATC codeV04CX10
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    8105213810
    10 CARTON in 1 CARTON (81052-138-10) / 1 VIAL, SINGLE-DOSE in 1 CARTON / 1.6 mL in 1 VIAL, SINGLE-DOSE (81052-138-01)

Annotations

UNII (FDA Substance ID)
4HUF3V875C
PAFOLACIANINE SODIUM
RxCUI 2586858
Orange Book
N214907
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "4HUF3V875C",
    "rxcui": "2586858",
    "inchikey": "LRVBSDMJFVZFHH-NFVAJSDSSA-J",
    "display_name": "PAFOLACIANINE SODIUM",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "d21952b9-7c4e-3a56-e053-2a95a90a0ab0": {
      "match": "brand_token",
      "title": "CYTALUX (PAFOLACIANINE INJECTION) INJECTION [ON TARGET LABORATORIES, INC.]",
      "spl_version": "10",
      "published_date": "2026-03-18"
    }
  },
  "productid": "81052-138_4cc23694-63af-f9f1-e063-6394a90a4ce0",
  "productndc": "81052-138",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "214907",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 3.2MG BASE/1.6ML (EQ 2MG BASE/ML)",
        "product_no": "001",
        "approval_date": "Nov 29, 2021"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PAFOLACIANINE SODIUM",
  "proprietary_name": "Cytalux",
  "active_ingred_unit": "mg/1.6mL",
  "application_number": "NDA214907",
  "marketing_category": "NDA",
  "nonproprietary_name": "Pafolacianine injection",
  "start_marketing_date": "20211129",
  "active_numerator_strength": "3.2"
}

Access this data programmatically

Query Cytalux and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.