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United States · US · US:0270-1111_2124d0de-8f96-6f0d-6c42-7296def2661f

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 · 4

  • ndc11
    0270111101
    5 VIAL, SINGLE-DOSE in 1 BOX (0270-1111-01) / 10 mL in 1 VIAL, SINGLE-DOSE
  • ndc11
    0270111102
    5 VIAL, SINGLE-DOSE in 1 BOX (0270-1111-02) / 15 mL in 1 VIAL, SINGLE-DOSE
  • ndc11
    0270111103
    5 VIAL, SINGLE-DOSE in 1 BOX (0270-1111-03) / 20 mL in 1 VIAL, SINGLE-DOSE
  • ndc11
    0270111104
    5 VIAL, SINGLE-DOSE in 1 BOX (0270-1111-04) / 5 mL in 1 VIAL, SINGLE-DOSE

Annotations

UNII (FDA Substance ID)
0199MV609F
GADOTERIDOL
RxCUI 25483
Orange Book
N020131
AP
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_2124d0de-8f96-6f0d-6c42-7296def2661f",
  "productndc": "0270-1111",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "020131",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "279.3MG/ML",
        "product_no": "001",
        "approval_date": "Nov 16, 1992"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "GADOTERIDOL",
  "proprietary_name": "ProHance",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA020131",
  "marketing_category": "NDA",
  "nonproprietary_name": "gadoteridol",
  "start_marketing_date": "19921116",
  "active_numerator_strength": "279.3"
}

Related drugs

Other records sharing ATC code V08CA04.

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