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  5. NDC Package Code: 81565-205-02 Fentanyl Citrate

NDC Package 81565-205-02 Fentanyl Citrate

Injection Intramuscular; 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:
81565-205-02
Package Description:
25 VIAL in 1 CARTON / 2 mL in 1 VIAL (81565-205-01)
Product Code:
81565-205
Proprietary Name:
Fentanyl Citrate
Non-Proprietary Name:
Fentanyl Citrate
Substance Name:
Fentanyl Citrate
Usage Information:
This medication is used to help relieve sudden (breakthrough) cancer pain in people who are regularly taking moderate to large amounts of opioid pain medication. Fentanyl belongs to a class of drugs known as opioid analgesics. It works in the brain to change how your body feels and responds to pain. This medication should not be used to relieve mild or short-term pain (such as due to headache/migraine, dental procedures, surgery).
11-Digit NDC Billing Format:
81565020502
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
  • RxCUI: 1735003 - fentaNYL citrate 100 MCG in 2 ML Injection
  • RxCUI: 1735003 - 2 ML fentanyl 0.05 MG/ML Injection
  • RxCUI: 1735003 - fentanyl (as fentanyl citrate) 50 MCG/ML per 2 ML Injection
  • RxCUI: 1735003 - fentanyl citrate 100 MCG per 2 ML Injection
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Phlow Corp.
    Dosage Form:
    Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
    Administration Route(s):
  • Intramuscular - Administration within a muscle.
  • Intravenous - Administration within or into a vein or veins.
    • Active Ingredient(s):
  • FENTANYL CITRATE 50 ug/mL
    • Pharmacologic Class(es):
  • Full Opioid Agonists - [MoA] (Mechanism of Action)
  • Opioid Agonist - [EPC] (Established Pharmacologic Class)
    • DEA Schedule:
    Schedule II (CII) Substances
    Sample Package:
    No
    FDA Application Number:
    NDA019101
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    01-11-2023
    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 81565-205-02?

    The NDC Packaged Code 81565-205-02 is assigned to a package of 25 vial in 1 carton / 2 ml in 1 vial (81565-205-01) of Fentanyl Citrate, a human prescription drug labeled by Phlow Corp.. The product's dosage form is injection and is administered via intramuscular; intravenous form.

    Is NDC 81565-205 included in the NDC Directory?

    Yes, Fentanyl Citrate with product code 81565-205 is active and included in the NDC Directory. The product was first marketed by Phlow Corp. on January 11, 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 81565-205-02?

    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 81565-205-02?

    The 11-digit format is 81565020502. 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
    5-3-281565-205-025-4-281565-0205-02