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  5. NDC Package Code: 55367-001-01 Ge-68 / Ga-68 Generator

NDC Package 55367-001-01 Ge-68 / Ga-68 Generator

Granule, For Solution - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

This product is an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

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:
55367-001-01
Package Description:
1 CANISTER in 1 CARTON / 1 GBq in 1 CANISTER
Product Code:
55367-001
Non-Proprietary Name:
Ge-68 / Ga-68 Generator
Substance Name:
Gallium Ga-68
11-Digit NDC Billing Format:
55367000101
Product Type:
Drug For Further Processing
Labeler Name:
Radiomedix, Inc
Dosage Form:
Granule, For Solution - A small medicinal particle or grain made available in its more stable dry form, to be reconstituted with solvent just before dispensing; the granules are so prepared to contain not only the medicinal agent, but the colorants, flavorants, and any other desired pharmaceutic ingredient.
Active Ingredient(s):
  • GALLIUM GA-68 1 GBq/GBq
    • Sample Package:
    N/A
    Marketing Category:
    DRUG FOR FURTHER PROCESSING - A drug (other than the bulk ingredient API) that is in an interim stage of manufacture, processing, preparation, or packaging, and not ready for human or animal use.
    Start Marketing Date:
    05-07-2021
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Unfinished Product:
    Yes
    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.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    55367-001-021 CANISTER in 1 CARTON / 2 GBq in 1 CANISTER
    55367-001-041 CANISTER in 1 CARTON / 4 GBq in 1 CANISTER

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 55367-001-01?

    The NDC Packaged Code 55367-001-01 is assigned to an UNFINISHED drug package of 1 canister in 1 carton / 1 gbq in 1 canister of Ge-68 / Ga-68 Generator, drug for further processing labeled by Radiomedix, Inc. The product's dosage form is granule, for solution and is administered via form.

    Is NDC 55367-001 included in the NDC Directory?

    Yes, Ge-68 / Ga-68 Generator is an UNFINISHED PRODUCT with code 55367-001 that is active and included in the NDC Directory. The product was first marketed by Radiomedix, Inc on May 07, 2021 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 11-digit format for NDC 55367-001-01?

    The 11-digit format is 55367000101. 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
    5-3-255367-001-015-4-255367-0001-01