Oxycodone And Acetaminophen Tablet
NDC Package 72189-256-72
Package Information
Oxycodone And Acetaminophen tablets is oxycodone hydrochloride 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 and Precautions ( 5.1)] , reserve oxycodone hydrochloride tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or opioid combination products):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 Direct Rx, this product is identified by NDC 72189-256 and is authorized under FDA application ANDA207510.
Identification & Billing
- RxCUI: 1049214 - oxyCODONE 10 MG / acetaminophen 325 MG Oral Tablet
- RxCUI: 1049214 - acetaminophen 325 MG / oxycodone hydrochloride 10 MG Oral Tablet
- RxCUI: 1049214 - APAP 325 MG / oxycodone hydrochloride 10 MG Oral Tablet
- RxCUI: 1049225 - oxyCODONE 7.5 MG / acetaminophen 325 MG Oral Tablet
- RxCUI: 1049225 - acetaminophen 325 MG / oxycodone hydrochloride 7.5 MG Oral Tablet
Clinical Specifications
Regulatory & Marketing
Hierarchy Structure
- 72189 - Direct Rx
- 72189-256 - Oxycodone And Acetaminophen
- 72189-256-72 - 120 TABLET in 1 BOTTLE
- 72189-256 - Oxycodone And Acetaminophen
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 (72189-256). Click a package code to view its specific billing and regulatory data.
* 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 72189-256-72 identifies a specific commercial package of 120 tablet in 1 bottle of Oxycodone And Acetaminophen, a human prescription drug labeled by Direct Rx. This product is billed for "EA" each discreet unit and contains an estimated amount of 120 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 Direct Rx on August 10, 2021. The current certification is valid through December 31, 2026.
How is this Direct Rx product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 72189025672. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 120 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:
Note: The zero is added to the Product segment to maintain the 5-4-2 structure.
