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  5. NDC Package Code: 76394-2642-3 Gallium Ga-68 Psma-11

NDC Package 76394-2642-3 Gallium Ga-68 Psma-11

Gallium Ga-68 Gozetotide Injection, Solution Intravenous - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. 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:
76394-2642-3
Package Description:
12 mL in 1 VIAL, MULTI-DOSE
Product Code:
76394-2642
Proprietary Name:
Gallium Ga-68 Psma-11
Non-Proprietary Name:
Gallium Ga-68 Gozetotide
Substance Name:
Gallium Ga-68 Gozetotide
Usage Information:
Ga 68 PSMA-11 Injection is indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer:with suspected metastasis who are candidates for initial definitive therapy.with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level.
11-Digit NDC Billing Format:
76394264203
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
1 EA
Product Type:
Human Prescription Drug
Labeler Name:
Ucla Biomedical Cyclotron
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.
    • Active Ingredient(s):
  • GALLIUM GA-68 GOZETOTIDE 5 mCi/mL
    • Pharmacologic Class(es):
  • Positron Emitting Activity - [MoA] (Mechanism of Action)
  • Radioactive Diagnostic Agent - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    NDA212642
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    12-09-2020
    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.

    Frequently Asked Questions

    What is NDC 76394-2642-3?

    The NDC Packaged Code 76394-2642-3 is assigned to a package of 12 ml in 1 vial, multi-dose of Gallium Ga-68 Psma-11, a human prescription drug labeled by Ucla Biomedical Cyclotron. The product's dosage form is injection, solution and is administered via intravenous form.This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package.

    Is NDC 76394-2642 included in the NDC Directory?

    Yes, Gallium Ga-68 Psma-11 with product code 76394-2642 is active and included in the NDC Directory. The product was first marketed by Ucla Biomedical Cyclotron on December 09, 2020 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 76394-2642-3?

    The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 1.

    What is the 11-digit format for NDC 76394-2642-3?

    The 11-digit format is 76394264203. 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 5-4-1 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
    5-4-176394-2642-35-4-276394-2642-03