Oxycodone And Acetaminophen Tablet
NDC Package 87063-034-01

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

Oxycodone And Acetaminophen tablets 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, which can occur at any dosage or duration [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. This formulation utilizes a tablet delivery system. Marketed by Asclemed Usa, Inc., this product is identified by NDC 87063-034 and is authorized under FDA application ANDA207510.

Identification & Billing

NDC Package Code
87063-034-01
Package Description
100 TABLET in 1 BOTTLE
Product Code
87063-034
11-Digit Billing Format
87063003401
RxNorm Crosswalk
  • 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: 1049221 - oxyCODONE 5 MG / acetaminophen 325 MG Oral Tablet
  • RxCUI: 1049221 - acetaminophen 325 MG / oxycodone hydrochloride 5 MG Oral Tablet

Clinical Specifications

Proprietary Name
Oxycodone And Acetaminophen
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, 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, which can occur at any dosage or duration [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. Oxycodone and Acetaminophen Tablets should not be used for an extended period of time unless the pain remains severe enough to require an opioid analgesic and for which alternative treatment options continue to be inadequate.
DEA Schedule
Schedule II (CII) Substances

Regulatory & Marketing

Labeler Name
Asclemed Usa, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA207510
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-01-2019
Listing Expiration
12-31-2026
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 (87063-034). Click a package code to view its specific billing and regulatory data.

87063-034-05
500 TABLET in 1 BOTTLE
87063-034-10
10 TABLET in 1 BOTTLE
87063-034-20
20 TABLET in 1 BOTTLE
87063-034-30
30 TABLET in 1 BOTTLE
87063-034-60
60 TABLET in 1 BOTTLE
87063-034-90
90 TABLET in 1 BOTTLE

* 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 87063-034-01 identifies a specific commercial package of 100 tablet in 1 bottle of Oxycodone And Acetaminophen, a human prescription drug labeled by Asclemed Usa, Inc.. 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 Asclemed Usa, Inc. on June 01, 2019. The current certification is valid through December 31, 2026.

How is this Asclemed Usa, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 87063003401. 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)
87063-034-01
11-Digit CMS (5-4-2)
87063-0034-01

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