MultiHance

Orange BookUNIISPLATC V08CA08

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerBRACCO DIAGNOSTICS INC

CountryUS (United States)

ATC codeV08CA08

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 4

ndc11
0270516412
5 VIAL, SINGLE-DOSE in 1 BOX (0270-5164-12) / 5 mL in 1 VIAL, SINGLE-DOSE
ndc11
0270516413
5 VIAL, SINGLE-DOSE in 1 BOX (0270-5164-13) / 10 mL in 1 VIAL, SINGLE-DOSE
ndc11
0270516414
5 VIAL, SINGLE-DOSE in 1 BOX (0270-5164-14) / 15 mL in 1 VIAL, SINGLE-DOSE
ndc11
0270516415
5 VIAL, SINGLE-DOSE in 1 BOX (0270-5164-15) / 20 mL in 1 VIAL, SINGLE-DOSE

Annotations

UNII (FDA Substance ID)

3Q6PPC19PO

GADOBENATE DIMEGLUMINE

RxCUI 68173

Orange Book

N021357

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "3Q6PPC19PO",
    "rxcui": "68173",
    "inchikey": "OCDAWJYGVOLXGZ-VPVMAENOSA-K",
    "display_name": "GADOBENATE DIMEGLUMINE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "f63abe56-46d9-4e32-afb1-f4e22370717d": {
      "match": "brand_token",
      "title": "MULTIHANCE (GADOBENATE DIMEGLUMINE) INJECTION, SOLUTION [BRACCO DIAGNOSTICS INC]",
      "spl_version": "22",
      "published_date": "2025-03-21"
    }
  },
  "productid": "0270-5164_0e7d3da8-78fa-b4ae-4a43-15919e900ebe",
  "productndc": "0270-5164",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "021357",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "2.645GM/5ML (529MG/ML)",
        "product_no": "001",
        "approval_date": "Nov 23, 2004"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "5.29GM/10ML (529MG/ML)",
        "product_no": "002",
        "approval_date": "Nov 23, 2004"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "7.935GM/15ML (529MG/ML)",
        "product_no": "003",
        "approval_date": "Nov 23, 2004"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "10.58GM/20ML (529MG/ML)",
        "product_no": "004",
        "approval_date": "Nov 23, 2004"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "GADOBENATE DIMEGLUMINE",
  "proprietary_name": "MultiHance",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA021357",
  "marketing_category": "NDA",
  "nonproprietary_name": "gadobenate dimeglumine",
  "start_marketing_date": "20041123",
  "active_numerator_strength": "529"
}

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