1. Labeler Index
  2. Bayer Healthcare Pharmaceuticals Inc.
  3. 50419-325
  4. NDC Package Code: 50419-325-12 Gadavist

NDC Package 50419-325-12 Gadavist

Gadobutrol Injection 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:
50419-325-12
Package Description:
2 CARTON in 1 BOX / 10 VIAL, SINGLE-DOSE in 1 CARTON / 10 mL in 1 VIAL, SINGLE-DOSE
Product Code:
50419-325
Proprietary Name:
Gadavist
Non-Proprietary Name:
Gadobutrol
Substance Name:
Gadobutrol
Usage Information:
Gadavist is contraindicated in patients with history of severe hypersensitivity reactions to Gadavist.
11-Digit NDC Billing Format:
50419032512
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:
Bayer Healthcare Pharmaceuticals Inc.
Dosage Form:
Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Administration Route(s):
  • Intravenous - Administration within or into a vein or veins.
  • Intravenous - Administration within or into a vein or veins.
  • Intravenous - Administration within or into a vein or veins.
    • Active Ingredient(s):
  • GADOBUTROL 604.72 mg/mL
  • GADOBUTROL 604.72 mg/mL
  • GADOBUTROL 604.72 mg/mL
    • Pharmacologic Class(es):
  • Gadolinium-based Contrast Agent - [EPC] (Established Pharmacologic Class)
  • Magnetic Resonance Contrast Activity - [MoA] (Mechanism of Action)
  • Gadolinium-based Contrast Agent - [EPC] (Established Pharmacologic Class)
  • Magnetic Resonance Contrast Activity - [MoA] (Mechanism of Action)
  • Gadolinium-based Contrast Agent - [EPC] (Established Pharmacologic Class)
  • Magnetic Resonance Contrast Activity - [MoA] (Mechanism of Action)
    • Sample Package:
    No
    FDA Application Number:
    NDA201277
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    03-14-2011
    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 50419-325-12 HCPCS crosswalk information with package details and bill units information.

    NDC Billing CodeHCPCS CodeHCPCS Code Desc.DosagePackage SizePackage QuantityBillable UnitsBillable Units / Pkg
    50419032512A9585Gadobutrol injection0.1 ML10201002000

    * Please review the disclaimer below.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    50419-325-112 CARTON in 1 BOX / 10 VIAL, SINGLE-DOSE in 1 CARTON / 7.5 mL in 1 VIAL, SINGLE-DOSE
    50419-325-132 CARTON in 1 BOX / 10 VIAL, SINGLE-DOSE in 1 CARTON / 15 mL in 1 VIAL, SINGLE-DOSE
    50419-325-142 CARTON in 1 BOX / 5 BOTTLE, GLASS in 1 CARTON / 30 mL in 1 BOTTLE, GLASS
    50419-325-1510 BOTTLE, GLASS in 1 BOX / 65 mL in 1 BOTTLE, GLASS
    50419-325-182 CARTON in 1 BOX / 5 BOTTLE, GLASS in 1 CARTON / 30 mL in 1 BOTTLE, GLASS
    50419-325-1910 BOTTLE, GLASS in 1 BOX / 65 mL in 1 BOTTLE, GLASS
    50419-325-275 SYRINGE, GLASS in 1 BOX / 7.5 mL in 1 SYRINGE, GLASS
    50419-325-285 SYRINGE, GLASS in 1 BOX / 10 mL in 1 SYRINGE, GLASS
    50419-325-295 SYRINGE, GLASS in 1 BOX / 15 mL in 1 SYRINGE, GLASS
    50419-325-3715 CARTON in 1 BOX / 3 VIAL, SINGLE-DOSE in 1 CARTON / 2 mL in 1 VIAL, SINGLE-DOSE
    50419-325-7210 VIAL, SINGLE-DOSE in 1 CARTON / 10 mL in 1 VIAL, SINGLE-DOSE
    50419-325-7330 mL in 1 BOTTLE, GLASS
    50419-325-7465 mL in 1 BOTTLE, GLASS
    50419-325-755 SYRINGE, GLASS in 1 BOX / 10 mL in 1 SYRINGE, GLASS

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 50419-325-12?

    The NDC Packaged Code 50419-325-12 is assigned to a package of 2 carton in 1 box / 10 vial, single-dose in 1 carton / 10 ml in 1 vial, single-dose of Gadavist, a human prescription drug labeled by Bayer Healthcare Pharmaceuticals Inc.. The product's dosage form is injection and is administered via intravenous form.

    Is NDC 50419-325 included in the NDC Directory?

    Yes, Gadavist with product code 50419-325 is active and included in the NDC Directory. The product was first marketed by Bayer Healthcare Pharmaceuticals Inc. on March 14, 2011 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 50419-325-12?

    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 50419-325-12?

    The 11-digit format is 50419032512. 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 5-3-2 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
    5-3-250419-325-125-4-250419-0325-12