Prolate Tablet
NDC Package 72245-682-03

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 and acetaminophen) tablets is 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. This formulation utilizes a tablet delivery system. Marketed by Forte Bio-pharma Llc, this product is identified by NDC 72245-682 and is authorized under FDA application ANDA040608.

Identification & Billing

NDC Package Code
72245-682-03
Package Description
30 TABLET in 1 BOTTLE, PLASTIC
Product Code
72245-682
11-Digit Billing Format
72245068203
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
30 EA
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

Clinical Specifications

Proprietary Name
Prolate
Non-Proprietary Name
Oxycodone And Acetaminophen
Substance Name
Acetaminophen; Oxycodone Hydrochloride
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
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
DEA Schedule
Schedule II (CII) Substances

Regulatory & Marketing

Labeler Name
Forte Bio-pharma Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA040608
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
02-17-2020
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 (72245-682). Click a package code to view its specific billing and regulatory data.

72245-682-10
100 TABLET 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 72245-682-03 identifies a specific commercial package of 30 tablet in 1 bottle, plastic of Prolate, a human prescription drug labeled by Forte Bio-pharma Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 30 billable units per package. This tablet 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 February 17, 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: 72245068203. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 30 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)
72245-682-03
11-Digit CMS (5-4-2)
72245-0682-03

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