NDC Package 72245-683-10 Prolate

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

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:
72245-683-10
Package Description:
100 TABLET in 1 BOTTLE, PLASTIC
Product Code:
Proprietary Name:
Prolate
Non-Proprietary Name:
Oxycodone And Acetaminophen
Substance Name:
Acetaminophen; Oxycodone Hydrochloride
Usage Information:
Oxycodone and acetaminophen tablets are 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 and acetaminophen tablets 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:
72245068310
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
100 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 1014599 - oxyCODONE HCl 10 MG / acetaminophen 300 MG Oral Tablet
  • RxCUI: 1014599 - acetaminophen 300 MG / oxycodone hydrochloride 10 MG Oral Tablet
  • RxCUI: 1014599 - APAP 300 MG / oxycodone hydrochloride 10 MG Oral Tablet
  • RxCUI: 1014615 - oxyCODONE HCl 5 MG / acetaminophen 300 MG Oral Tablet
  • RxCUI: 1014615 - acetaminophen 300 MG / oxycodone hydrochloride 5 MG Oral Tablet
  • Product Type:
    Human Prescription Drug
    Labeler Name:
    Forte Bio-pharma Llc
    Dosage Form:
    Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
  • DEA Schedule:
    Schedule II (CII) Substances
    Sample Package:
    No
    FDA Application Number:
    ANDA040608
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    02-17-2020
    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
    72245-683-0330 TABLET in 1 BOTTLE, PLASTIC

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 72245-683-10?

    The NDC Packaged Code 72245-683-10 is assigned to a package of 100 tablet in 1 bottle, plastic of Prolate, a human prescription drug labeled by Forte Bio-pharma Llc. The product's dosage form is tablet and is administered via oral form.This product is billed for "EA" each discreet unit and contains an estimated amount of 100 billable units per package.

    Is NDC 72245-683 included in the NDC Directory?

    Yes, Prolate with product code 72245-683 is active and included in the NDC Directory. The product was first marketed by Forte Bio-pharma Llc on February 17, 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 72245-683-10?

    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 100.

    What is the 11-digit format for NDC 72245-683-10?

    The 11-digit format is 72245068310. 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
    5-3-272245-683-105-4-272245-0683-10