Prohance Injection, Solution
NDC Package 0270-1111-01

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

Prohance (gadoteridol) injection is proHance is contraindicated in patients with known allergic or hypersensitivity reactions to ProHance (see WARNINGS). This formulation utilizes a injection, solution delivery system. Marketed by Bracco Diagnostics Inc, this product is identified by NDC 0270-1111 and is authorized under FDA application NDA020131.

Identification & Billing

NDC Package Code
0270-1111-01
Package Description
5 VIAL, SINGLE-DOSE in 1 BOX / 10 mL in 1 VIAL, SINGLE-DOSE
Product Code
0270-1111
11-Digit Billing Format
00270111101
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.

Clinical Specifications

Proprietary Name
Prohance
Non-Proprietary Name
Gadoteridol
Substance Name
Gadoteridol
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.
  • Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
Pharmacologic Class
Usage Information
ProHance is contraindicated in patients with known allergic or hypersensitivity reactions to ProHance (see WARNINGS).

Regulatory & Marketing

Labeler Name
Bracco Diagnostics Inc
Product Type
Human Prescription Drug
FDA Application #
NDA020131
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
11-16-1992
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 (0270-1111). Click a package code to view its specific billing and regulatory data.

0270-1111-02
5 VIAL, SINGLE-DOSE in 1 BOX / 15 mL in 1 VIAL, SINGLE-DOSE
0270-1111-03
5 VIAL, SINGLE-DOSE in 1 BOX / 20 mL in 1 VIAL, SINGLE-DOSE
0270-1111-04
5 VIAL, SINGLE-DOSE in 1 BOX / 5 mL in 1 VIAL, SINGLE-DOSE
0270-1111-70
5 VIAL, PHARMACY BULK PACKAGE in 1 BOX / 50 mL in 1 VIAL, PHARMACY BULK PACKAGE
0270-1111-85
5 VIAL, PHARMACY BULK PACKAGE in 1 BOX / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE

* 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 0270-1111-01 identifies a specific commercial package of 5 vial, single-dose in 1 box / 10 ml in 1 vial, single-dose of Prohance, a human prescription drug labeled by Bracco Diagnostics Inc. This injection, solution is formulated for intravenous use and contains gadoteridol 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 16, 1992. 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: 00270111101. 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)
0270-1111-01
11-Digit CMS (5-4-2)
00270-1111-01

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