1. Labeler Index
  2. Bracco Diagnostics Inc
  3. 0270-1111
  4. NDC Package Code: 0270-1111-01 Prohance

NDC Package 0270-1111-01 Prohance

Gadoteridol Injection, Solution Intravenous - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. NDC HCPCS Crosswalk
    3. Other Packages
    4. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

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
Proprietary Name:
Prohance
Non-Proprietary Name:
Gadoteridol
Substance Name:
Gadoteridol
Usage Information:
NOT FOR DIRECT INFUSIONThe pharmacy bulk package is used as a multiple dose container with an appropriate transfer device to fill empty sterile syringes. Use the following procedures when transferring ProHance from the pharmacy bulk package to individual syringes:Use of this product is restricted to a suitable work area, such as a laminar flow hood, utilizing aseptic techniquePrior to entering the vial, remove the seal and cleanse the rubber closure with a suitable antiseptic agentThe container closure may be penetrated only one time, utilizing a suitable transfer device or dispensing set that allows measured dispensing of the contentsOnce the pharmacy bulk package is punctured, it should not be removed from the aseptic work area during the entire period of useWithdrawal of container contents should be accomplished without delay. A maximum time of 8 hours from initial closure entry is permitted to complete fluid transfer operationsAny unused contents must be discarded by 8 hours after initial puncture of the bulk packageOnce drawn into syringe, administer transferred agent promptly for single-dose administration
11-Digit NDC Billing Format:
00270111101
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Product Type:
Human Prescription Drug
Labeler Name:
Bracco Diagnostics Inc
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(s):
  • Intravenous - Administration within or into a vein or veins.
  • Intravenous - Administration within or into a vein or veins.
    • Active Ingredient(s):
  • GADOTERIDOL 279.3 mg/mL
  • GADOTERIDOL 279.3 mg/mL
    • Pharmacologic Class(es):
  • Magnetic Resonance Contrast Activity - [MoA] (Mechanism of Action)
  • Paramagnetic Contrast Agent - [EPC] (Established Pharmacologic Class)
  • Magnetic Resonance Contrast Activity - [MoA] (Mechanism of Action)
  • Paramagnetic Contrast Agent - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    NDA020131
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    11-16-1992
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    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 disclaimer below.

    NDC HCPCS Crosswalk

    This crosswalk is intended to help the public understand which drug products (identified by NDCs) are assigned to which HCPCS billing codes.

    NDC 0270-1111-01 HCPCS crosswalk information with package details and bill units information.

    NDC Billing CodeHCPCS CodeHCPCS Code Desc.DosagePackage SizePackage QuantityBillable UnitsBillable Units / Pkg
    00270111101A9579Gad-base mr contrast nos,1ml1 ML1051050

    * Please review the disclaimer below.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    0270-1111-025 VIAL, SINGLE-DOSE in 1 BOX / 15 mL in 1 VIAL, SINGLE-DOSE
    0270-1111-035 VIAL, SINGLE-DOSE in 1 BOX / 20 mL in 1 VIAL, SINGLE-DOSE
    0270-1111-045 VIAL, SINGLE-DOSE in 1 BOX / 5 mL in 1 VIAL, SINGLE-DOSE
    0270-1111-705 VIAL, PHARMACY BULK PACKAGE in 1 BOX / 50 mL in 1 VIAL, PHARMACY BULK PACKAGE
    0270-1111-855 VIAL, PHARMACY BULK PACKAGE in 1 BOX / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 0270-1111-01?

    The NDC Packaged Code 0270-1111-01 is assigned to a 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. The product's dosage form is injection, solution and is administered via intravenous form.

    Is NDC 0270-1111 included in the NDC Directory?

    Yes, Prohance with product code 0270-1111 is active and included in the NDC Directory. The product was first marketed by Bracco Diagnostics Inc on November 16, 1992 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 0270-1111-01?

    The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.

    What is the 11-digit format for NDC 0270-1111-01?

    The 11-digit format is 00270111101. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 4-4-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    4-4-20270-1111-015-4-200270-1111-01