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United States · US · US:0270-1111_ecd7e9ad-58e6-b31c-0b80-cce5b07fcad2

ProHance

Orange BookUNIISPLATC V08CA04

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

Identification

ManufacturerBracco Diagnostics Inc
CountryUS (United States)
ATC codeV08CA04
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    0270111170
    5 VIAL, PHARMACY BULK PACKAGE in 1 BOX (0270-1111-70) / 50 mL in 1 VIAL, PHARMACY BULK PACKAGE
  • ndc11
    0270111185
    5 VIAL, PHARMACY BULK PACKAGE in 1 BOX (0270-1111-85) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE

Annotations

UNII (FDA Substance ID)
0199MV609F
GADOTERIDOL
RxCUI 25483
Orange Book
N021489
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "0199MV609F",
    "rxcui": "25483",
    "inchikey": "DPNNNPAKRZOSMO-UHFFFAOYSA-K",
    "display_name": "GADOTERIDOL",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "778aee03-7d4c-481a-be8a-a75db0702f5a": {
      "match": "brand_token",
      "title": "PROHANCE (GADOTERIDOL) INJECTION, SOLUTION [BRACCO DIAGNOSTICS INC]",
      "spl_version": "24",
      "published_date": "2025-03-21"
    }
  },
  "productid": "0270-1111_ecd7e9ad-58e6-b31c-0b80-cce5b07fcad2",
  "productndc": "0270-1111",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "021489",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "279.3MG/ML",
        "product_no": "001",
        "approval_date": "Oct 9, 2003"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "GADOTERIDOL",
  "proprietary_name": "ProHance",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA021489",
  "marketing_category": "NDA",
  "nonproprietary_name": "gadoteridol",
  "start_marketing_date": "20031009",
  "active_numerator_strength": "279.3"
}

Related drugs

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