multihance

Generic: gadobenate dimeglumine

Labeler: bracco diagnostics inc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name multihance
Generic Name gadobenate dimeglumine
Labeler bracco diagnostics inc
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

gadobenate dimeglumine 529 mg/mL

Manufacturer
BRACCO DIAGNOSTICS INC

Identifiers & Regulatory

Product NDC 0270-5164
Product ID 0270-5164_0e7d3da8-78fa-b4ae-4a43-15919e900ebe
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021357
Listing Expiration 2026-12-31
Marketing Start 2004-11-23

Pharmacologic Class

Classes
gadolinium-based contrast agent [epc] magnetic resonance contrast activity [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 02705164
Hyphenated Format 0270-5164

Supplemental Identifiers

UNII
3Q6PPC19PO

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name multihance (source: ndc)
Generic Name gadobenate dimeglumine (source: ndc)
Application Number NDA021357 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 529 mg/mL
source: ndc
Packaging
  • 5 VIAL, SINGLE-DOSE in 1 BOX (0270-5164-12) / 5 mL in 1 VIAL, SINGLE-DOSE
  • 5 VIAL, SINGLE-DOSE in 1 BOX (0270-5164-13) / 10 mL in 1 VIAL, SINGLE-DOSE
  • 5 VIAL, SINGLE-DOSE in 1 BOX (0270-5164-14) / 15 mL in 1 VIAL, SINGLE-DOSE
  • 5 VIAL, SINGLE-DOSE in 1 BOX (0270-5164-15) / 20 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (4)

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

Ingredients (1)

gadobenate dimeglumine (529 mg/mL)

Linked Drug Pages (1)

MultiHance ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "0e7d3da8-78fa-b4ae-4a43-15919e900ebe", "openfda": {"unii": ["3Q6PPC19PO"], "spl_set_id": ["59077a3e-5f03-4342-ae24-856267545631"], "manufacturer_name": ["BRACCO DIAGNOSTICS INC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "5 VIAL, SINGLE-DOSE in 1 BOX (0270-5164-12)  / 5 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "0270-5164-12", "marketing_start_date": "20041123"}, {"sample": false, "description": "5 VIAL, SINGLE-DOSE in 1 BOX (0270-5164-13)  / 10 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "0270-5164-13", "marketing_start_date": "20041123"}, {"sample": false, "description": "5 VIAL, SINGLE-DOSE in 1 BOX (0270-5164-14)  / 15 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "0270-5164-14", "marketing_start_date": "20041123"}, {"sample": false, "description": "5 VIAL, SINGLE-DOSE in 1 BOX (0270-5164-15)  / 20 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "0270-5164-15", "marketing_start_date": "20041123"}], "brand_name": "MultiHance", "product_id": "0270-5164_0e7d3da8-78fa-b4ae-4a43-15919e900ebe", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Gadolinium-based Contrast Agent [EPC]", "Magnetic Resonance Contrast Activity [MoA]"], "product_ndc": "0270-5164", "generic_name": "gadobenate dimeglumine", "labeler_name": "BRACCO DIAGNOSTICS INC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "MultiHance", "active_ingredients": [{"name": "GADOBENATE DIMEGLUMINE", "strength": "529 mg/mL"}], "application_number": "NDA021357", "marketing_category": "NDA", "marketing_start_date": "20041123", "listing_expiration_date": "20261231"}