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  5. NDC Package Code: 72245-648-50 Prolate

NDC Package 72245-648-50 Prolate

Oxycodone Hydrochloride And Acetaminophen Solution Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. 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:
72245-648-50
Package Description:
500 mL in 1 BOTTLE, PLASTIC
Product Code:
72245-648
Proprietary Name:
Prolate
Non-Proprietary Name:
Oxycodone Hydrochloride And Acetaminophen
Substance Name:
Acetaminophen; Oxycodone Hydrochloride
Usage Information:
Oxycodone hydrochloride and acetaminophen oral solution is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.Limitations of UseBecause of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [see WARNINGS], reserve oxycodone hydrochloride and acetaminophen oral solution for use in patients for whom alternative treatment options [e.g., non-opioid analgesics] Have not been tolerated, or are not expected to be tolerated,Have not provided adequate analgesia, or are not expected to provide adequate analgesia
11-Digit NDC Billing Format:
72245064850
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
500 ML
NDC to RxNorm Crosswalk:
  • RxCUI: 2105822 - oxyCODONE HCl 10 MG / acetaminophen 300 MG in 5 mL Oral Solution
  • RxCUI: 2105822 - acetaminophen 60 MG/ML / oxycodone hydrochloride 2 MG/ML Oral Solution
  • RxCUI: 2105822 - APAP 60 MG/ML / Oxycodone Hydrochloride 2 MG/ML Oral Solution
  • RxCUI: 2105822 - oxycodone HCl 10 MG / acetaminophen 300 MG per 5 ML Oral Solution
  • RxCUI: 2105822 - oxycodone HCl 2 MG/ML / acetaminophen 60 MG/ML Oral Solution
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Forte Bio-pharma Llc
    Dosage Form:
    Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • ACETAMINOPHEN 300 mg/5mL
  • OXYCODONE HYDROCHLORIDE 10 mg/5mL
    • 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:
    ANDA202142
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    03-01-2020
    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.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    72245-648-12120 mL in 1 BOTTLE, PLASTIC

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 72245-648-50?

    The NDC Packaged Code 72245-648-50 is assigned to a package of 500 ml in 1 bottle, plastic of Prolate, a human prescription drug labeled by Forte Bio-pharma Llc. The product's dosage form is solution and is administered via oral form.This product is billed per "ML" milliliter and contains an estimated amount of 500 billable units per package.

    Is NDC 72245-648 included in the NDC Directory?

    Yes, Prolate with product code 72245-648 is active and included in the NDC Directory. The product was first marketed by Forte Bio-pharma Llc on March 01, 2020 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 72245-648-50?

    The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume. The calculated billable units for this package is 500.

    What is the 11-digit format for NDC 72245-648-50?

    The 11-digit format is 72245064850. 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
    5-3-272245-648-505-4-272245-0648-50