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  5. NDC Package Code: 65219-028-05 Ganirelix Acetate

NDC Package 65219-028-05 Ganirelix Acetate

Injection Subcutaneous - 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:
65219-028-05
Package Description:
1 SYRINGE, GLASS in 1 CARTON / 1 mL in 1 SYRINGE, GLASS
Product Code:
65219-028
Proprietary Name:
Ganirelix Acetate
Non-Proprietary Name:
Ganirelix Acetate
Substance Name:
Ganirelix Acetate
Usage Information:
Ganirelix Acetate Injection is indicated for the inhibition of premature LH surges in women undergoing controlled ovarian hyperstimulation.
11-Digit NDC Billing Format:
65219002805
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
  • RxCUI: 855200 - ganirelix acetate 250 MCG in 0.5 ML Prefilled Syringe
  • RxCUI: 855200 - 0.5 ML ganirelix acetate 0.5 MG/ML Prefilled Syringe
  • RxCUI: 855200 - ganirelix acetate 0.5 MG/ML 0.5 ML Prefilled Syringe
  • RxCUI: 855200 - ganirelix acetate 250 MCG per 0.5 ML Prefilled Syringe
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Fresenius Kabi Usa, Llc
    Dosage Form:
    Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
    Administration Route(s):
  • Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
    • Active Ingredient(s):
  • GANIRELIX ACETATE 250 ug/.5mL
    • Pharmacologic Class(es):
  • Decreased GnRH Secretion - [PE] (Physiologic Effect)
  • Gonadotropin Releasing Hormone Receptor Antagonist - [EPC] (Established Pharmacologic Class)
  • Gonadotropin Releasing Hormone Receptor Antagonists - [MoA] (Mechanism of Action)
    • Sample Package:
    No
    FDA Application Number:
    ANDA215658
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    03-24-2023
    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 65219-028-05?

    The NDC Packaged Code 65219-028-05 is assigned to a package of 1 syringe, glass in 1 carton / 1 ml in 1 syringe, glass of Ganirelix Acetate, a human prescription drug labeled by Fresenius Kabi Usa, Llc. The product's dosage form is injection and is administered via subcutaneous form.

    Is NDC 65219-028 included in the NDC Directory?

    Yes, Ganirelix Acetate with product code 65219-028 is active and included in the NDC Directory. The product was first marketed by Fresenius Kabi Usa, Llc on March 24, 2023 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 65219-028-05?

    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 65219-028-05?

    The 11-digit format is 65219002805. 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
    5-3-265219-028-055-4-265219-0028-05