Multihance Injection, Solution
NDC Package 0270-5264-16

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Multihance (gadobenate dimeglumine) injection is the pharmacy bulk package is used as a multiple dose container with an appropriate transfer device to fill empty syringes.MultiHance Multipack injection should be drawn into the syringe and administered using sterile technique. This formulation utilizes a injection, solution delivery system. Marketed by Bracco Diagnostics Inc, this product is identified by NDC 0270-5264 and is authorized under FDA application NDA021358.

Identification & Billing

NDC Package Code
0270-5264-16
Package Description
5 BOTTLE, GLASS in 1 BOX / 50 mL in 1 BOTTLE, GLASS
Product Code
0270-5264
11-Digit Billing Format
00270526416
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.

Clinical Specifications

Proprietary Name
Multihance
Non-Proprietary Name
Gadobenate Dimeglumine
Substance Name
Gadobenate Dimeglumine
Dosage Form
Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
GADOBENATE DIMEGLUMINE 529 mg/mL
Pharmacologic Class
Usage Information
The pharmacy bulk package is used as a multiple dose container with an appropriate transfer device to fill empty syringes.MultiHance Multipack injection should be drawn into the syringe and administered using sterile technique. Unused portions of the drug must be discarded.When MultiHance Multipack injection is to be injected using plastic disposable syringes, the agent should be drawn into the syringe and used immediately.The transferring of MultiHance (gadobenate dimeglumine) injection from the Pharmacy Bulk Package should be performed in a suitable work area, such as a laminar flow hood, utilizing aseptic technique.The container closure may be penetrated only one time, utilizing a suitable transfer device. Once the pharmacy bulk package is punctured, it should not be removed from the aseptic work area during the entire period of use.The withdrawal of container contents should be accomplished without delay. However, should this not be possible, a maximum time of 8 hours from initial closure entry is permitted to complete fluid transfer operation. Any unused MultiHance Multipack injection must be discarded 8 hours after initial puncture of the bulk package.Temperature of container after the closure has been entered should not exceed 25°C (77°F).

Regulatory & Marketing

Labeler Name
Bracco Diagnostics Inc
Product Type
Human Prescription Drug
FDA Application #
NDA021358
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
11-23-2004
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Other Available Packages

The following commercial packages are registered under the same Product NDC (0270-5264). Click a package code to view its specific billing and regulatory data.

0270-5264-17
5 BOTTLE, GLASS in 1 BOX / 100 mL in 1 BOTTLE, GLASS

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 0270-5264-16 identifies a specific commercial package of 5 bottle, glass in 1 box / 50 ml in 1 bottle, glass of Multihance, a human prescription drug labeled by Bracco Diagnostics Inc. This injection, solution is formulated for intravenous use and contains gadobenate dimeglumine as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Bracco Diagnostics Inc on November 23, 2004. The current certification is valid through December 31, 2026.

How is this Bracco Diagnostics Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00270526416. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (4-4-2)
0270-5264-16
11-Digit CMS (5-4-2)
00270-5264-16

Note: The zero is added to the Labeler segment to maintain the 5-4-2 structure.