0270-5164 NDC - MULTIHANCE ()

Drug Information

  • Product NDC: 0270-5164
  • Proprietary Name: MultiHance
  • Non Proprietary Name:
  • Active Ingredient(s): 529 mg/mL GADOBENATE DIMEGLUMINE
  • Administration Route(s):
  • Dosage Form(s):
  • Pharmacy Class(es): Gadolinium-based Contrast Agent [EPC]; Magnetic Resonance Contrast Activity [MoA]

Labeler Information

Field Name Field Value
Labeler Name: Bracco Diagnostics Inc
Product Type:
FDA Application Number: NDA021357
Marketing Category: NDA
Start Marketing Date:11/23/2004
End Marketing Date:12/31/2012

Package Information

No. Package Code Package Description Billing Unit
10270-5164-125 VIAL, SINGLE-DOSE in 1 BOX (0270-5164-12) / 5 mL in 1 VIAL, SINGLE-DOSEML
20270-5164-135 VIAL, SINGLE-DOSE in 1 BOX (0270-5164-13) / 10 mL in 1 VIAL, SINGLE-DOSEML
30270-5164-145 VIAL, SINGLE-DOSE in 1 BOX (0270-5164-14) / 15 mL in 1 VIAL, SINGLE-DOSEML
40270-5164-155 VIAL, SINGLE-DOSE in 1 BOX (0270-5164-15) / 20 mL in 1 VIAL, SINGLE-DOSEML
50270-5164-185 SYRINGE in 1 BOX (0270-5164-18) / 10 mL in 1 SYRINGE
60270-5164-195 SYRINGE in 1 BOX (0270-5164-19) / 15 mL in 1 SYRINGE
70270-5164-205 SYRINGE in 1 BOX (0270-5164-20) / 20 mL in 1 SYRINGE

NDC Record

Field Name Field Value Definition
PRODUCT NDC0270-5164The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PROPRIETARY NAMEMultiHanceThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
START MARKETING DATE11/23/2004This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMENDAProduct types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
APPLICATION NUMBERNDA021357This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
LABELER NAMEBracco Diagnostics IncName of Company corresponding to the labeler code segment of the Product NDC.
PRODUCT NDC0270-5164The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PROPRIETARY NAMEMultiHanceThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
START MARKETING DATE11/23/2004This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMENDAProduct types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
APPLICATION NUMBERNDA021357This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
LABELER NAMEBRACCO DIAGNOSTICS INCName of Company corresponding to the labeler code segment of the Product NDC.

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This page was last updated on: 11/21/2025

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