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United States · US · US:0270-7015_edc110ca-cf49-3620-34bb-cc6bc8c7a100

Vueway

Orange BookUNIISPLATC V08CA12

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

Identification

ManufacturerBRACCO DIAGNOSTICS INC
CountryUS (United States)
ATC codeV08CA12
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 9

  • ndc11
    0270701546
    25 VIAL, PHARMACY BULK PACKAGE in 1 CASE (0270-7015-46) / 30 mL in 1 VIAL, PHARMACY BULK PACKAGE
  • ndc11
    0270701548
    25 VIAL, PHARMACY BULK PACKAGE in 1 CASE (0270-7015-48) / 50 mL in 1 VIAL, PHARMACY BULK PACKAGE
  • ndc11
    0270701564
    6 CARTON in 1 CASE (0270-7015-64) / 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE
  • ndc11
    0270701566
    10 VIAL, PHARMACY BULK PACKAGE in 1 CASE (0270-7015-66) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE
  • ndc11
    0270701575
    10 VIAL in 1 CASE (0270-7015-75) / 30 mL in 1 VIAL
  • ndc11
    0270701576
    10 VIAL in 1 CASE (0270-7015-76) / 50 mL in 1 VIAL
  • ndc11
    0270701577
    10 VIAL in 1 CASE (0270-7015-77) / 100 mL in 1 VIAL
  • ndc11
    0270701581
    10 VIAL, PHARMACY BULK PACKAGE in 1 CASE (0270-7015-81) / 50 mL in 1 VIAL, PHARMACY BULK PACKAGE
  • ndc11
    0270701591
    10 VIAL, PHARMACY BULK PACKAGE in 1 CASE (0270-7015-91) / 30 mL in 1 VIAL, PHARMACY BULK PACKAGE

Annotations

UNII (FDA Substance ID)
S276568KOY
GADOPICLENOL
RxCUI 2618720
Orange Book
N216986
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "S276568KOY",
    "rxcui": "2618720",
    "inchikey": "GNRQMLROZPOLDG-UHFFFAOYSA-K",
    "display_name": "GADOPICLENOL",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "192725e9-e83e-1a36-33f2-abee55792ab3": {
      "match": "brand_token",
      "title": "VUEWAY (GADOPICLENOL) INJECTION [BRACCO DIAGNOSTICS INC]",
      "spl_version": "9",
      "published_date": "2026-04-06"
    }
  },
  "productid": "0270-7015_edc110ca-cf49-3620-34bb-cc6bc8c7a100",
  "productndc": "0270-7015",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "216986",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "1.4553GM/3ML (485.1MG/ML)",
        "product_no": "001",
        "approval_date": "Sep 21, 2022"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "3.63825GM/7.5ML (485.1MG/ML)",
        "product_no": "002",
        "approval_date": "Sep 21, 2022"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "4.851GM/10ML (485.1MG/ML)",
        "product_no": "003",
        "approval_date": "Sep 21, 2022"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "7.2765GM/15ML (485.1MG/ML)",
        "product_no": "004",
        "approval_date": "Sep 21, 2022"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "14.553GM/30ML (485.1MG/ML)",
        "product_no": "005",
        "approval_date": "Sep 21, 2022"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "24.255GM/50ML (485.1MG/ML)",
        "product_no": "006",
        "approval_date": "Sep 21, 2022"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "48.51GM/100ML (485.1MG/ML)",
        "product_no": "007",
        "approval_date": "Sep 21, 2022"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "GADOPICLENOL",
  "proprietary_name": "Vueway",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA216986",
  "marketing_category": "NDA",
  "nonproprietary_name": "Gadopiclenol",
  "start_marketing_date": "20220921",
  "active_numerator_strength": "485.1"
}

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