Prolate Solution
NDC Package 72245-648-50

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Prolate (oxycodone hydrochloride and acetaminophen) solution is 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. This formulation utilizes a solution delivery system. Marketed by Forte Bio-pharma Llc, this product is identified by NDC 72245-648 and is authorized under FDA application ANDA202142.

Identification & Billing

NDC Package Code
72245-648-50
Package Description
500 mL in 1 BOTTLE, PLASTIC
Product Code
72245-648
11-Digit Billing Format
72245064850
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
500 ML
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

Clinical Specifications

Proprietary Name
Prolate
Non-Proprietary Name
Oxycodone Hydrochloride And Acetaminophen
Substance Name
Acetaminophen; Oxycodone Hydrochloride
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
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
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
DEA Schedule
Schedule II (CII) Substances

Regulatory & Marketing

Labeler Name
Forte Bio-pharma Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA202142
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
03-01-2020
Listing Expiration
12-31-2027
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

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 full disclaimer at the bottom of this page.

Other Available Packages

The following commercial packages are registered under the same Product NDC (72245-648). Click a package code to view its specific billing and regulatory data.

72245-648-12
120 mL in 1 BOTTLE, PLASTIC

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 72245-648-50 identifies a specific commercial package of 500 ml in 1 bottle, plastic of Prolate, a human prescription drug labeled by Forte Bio-pharma Llc. This product is billed per "ML" milliliter and contains an estimated amount of 500 billable units per package. This solution is formulated for oral use and contains acetaminophen; oxycodone hydrochloride as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Forte Bio-pharma Llc on March 01, 2020. The current certification is valid through December 31, 2027.

How is this Forte Bio-pharma Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 72245064850. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 500 total billable units per package. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
72245-648-50
11-Digit CMS (5-4-2)
72245-0648-50

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.