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  5. NDC Package Code: 81565-204-02 Rocuronium

NDC Package 81565-204-02 Rocuronium

Rocuronium Bromide 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:
81565-204-02
Package Description:
10 VIAL in 1 TRAY / 5 mL in 1 VIAL (81565-204-01)
Product Code:
81565-204
Proprietary Name:
Rocuronium
Non-Proprietary Name:
Rocuronium Bromide
Substance Name:
Rocuronium Bromide
Usage Information:
Rocuronium Bromide Injection is indicated for inpatients and outpatients as an adjunct to general anesthesia to facilitate both rapid sequence and routine tracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation.
11-Digit NDC Billing Format:
81565020402
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
  • RxCUI: 1234995 - rocuronium bromide 10 MG/ML Injectable Solution
  • RxCUI: 1234995 - rocuronium bromide 100 MG per 10 ML Concentrate for Injectable Solution
  • RxCUI: 1234995 - rocuronium bromide 50 MG per 5 ML Concentrate for Injectable Solution
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Phlow Corporation
    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):
  • ROCURONIUM BROMIDE 10 mg/mL
    • Pharmacologic Class(es):
  • Neuromuscular Nondepolarizing Blockade - [PE] (Physiologic Effect)
  • Nondepolarizing Neuromuscular Blocker - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    ANDA078651
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    02-08-2022
    Listing Expiration Date:
    12-31-2025
    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 81565-204-02?

    The NDC Packaged Code 81565-204-02 is assigned to a package of 10 vial in 1 tray / 5 ml in 1 vial (81565-204-01) of Rocuronium, a human prescription drug labeled by Phlow Corporation. The product's dosage form is injection, solution and is administered via intravenous form.

    Is NDC 81565-204 included in the NDC Directory?

    Yes, Rocuronium with product code 81565-204 is active and included in the NDC Directory. The product was first marketed by Phlow Corporation on February 08, 2022 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 81565-204-02?

    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 81565-204-02?

    The 11-digit format is 81565020402. 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
    5-3-281565-204-025-4-281565-0204-02