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United States · US · US:71083-0020_ed28b4c6-15f3-495e-9e79-ce9610228aa5

NephroScan

Orange BookUNIISPL

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

Identification

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

Packs · 1

  • ndc11
    7108300205
    5 VIAL, SINGLE-DOSE in 1 CARTON (71083-0020-5) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (71083-0020-1)

Annotations

UNII (FDA Substance ID)
DX1U2629QE
SUCCIMER
RxCUI 3446
Orange Book
N214993
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "DX1U2629QE",
    "rxcui": "3446",
    "inchikey": "ACTRVOBWPAIOHC-XIXRPRMCSA-N",
    "display_name": "SUCCIMER",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "ddd90c4a-5792-49c9-837f-710d1a604742": {
      "match": "brand_token",
      "title": "NEPHROSCAN (SUCCIMER) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [THERAGNOSTICS INC]",
      "spl_version": "5",
      "published_date": "2024-10-04"
    }
  },
  "productid": "71083-0020_ed28b4c6-15f3-495e-9e79-ce9610228aa5",
  "productndc": "71083-0020",
  "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
  "orange_book": {
    "appl_no": "214993",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "N/A",
        "product_no": "001",
        "approval_date": "Feb 18, 2022"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "SUCCIMER",
  "proprietary_name": "NephroScan",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA214993",
  "marketing_category": "NDA",
  "nonproprietary_name": "SUCCIMER",
  "start_marketing_date": "20220218",
  "active_numerator_strength": "1"
}

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