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  5. NDC Package Code: 0054-8648-16 Roxicet

NDC Package 0054-8648-16 Roxicet

View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

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:
0054-8648-16
Package Description:
10 CUP, UNIT-DOSE in 1 CARTON / 5 mL in 1 CUP, UNIT-DOSE
Product Code:
0054-8648
Proprietary Name:
Roxicet
Usage Information:
This combination medication is used to help relieve moderate to severe pain. It contains a opioid pain reliever (oxycodone) and a non-opioid pain reliever (acetaminophen). Oxycodone works in the brain to change how your body feels and responds to pain. Acetaminophen can also reduce a fever.
11-Digit NDC Billing Format:
00054864816
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
  • RxCUI: 1049221 - oxyCODONE 5 MG / acetaminophen 325 MG Oral Tablet
  • RxCUI: 1049221 - acetaminophen 325 MG / oxycodone hydrochloride 5 MG Oral Tablet
  • RxCUI: 1049221 - APAP 325 MG / oxycodone hydrochloride 5 MG Oral Tablet
  • RxCUI: 1049580 - oxyCODONE HCl 5 MG / acetaminophen 325 MG in 5 mL Oral Solution
  • RxCUI: 1049580 - acetaminophen 65 MG/ML / oxycodone hydrochloride 1 MG/ML Oral Solution
    • Labeler Name:
    West-ward Pharmaceuticals Corp
    Sample Package:
    No
    FDA Application Number:
    ANDA089351
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    01-17-1991
    Listing Expiration Date:
    12-31-2019
    Exclude Flag:
    I
    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.

    Frequently Asked Questions

    What is NDC 0054-8648-16?

    The NDC Packaged Code 0054-8648-16 is assigned to a package of 10 cup, unit-dose in 1 carton / 5 ml in 1 cup, unit-dose of Roxicet, labeled by West-ward Pharmaceuticals Corp. The product's dosage form is and is administered via form.

    Is NDC 0054-8648 included in the NDC Directory?

    No, Roxicet with product code 0054-8648 is excluded from the NDC Directory because it's listing has been INACTIVATED by FDA. The product was first marketed by West-ward Pharmaceuticals Corp on January 17, 1991 and its listing in the NDC Directory is set to expire on December 31, 2019 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 0054-8648-16?

    The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.

    What is the 11-digit format for NDC 0054-8648-16?

    The 11-digit format is 00054864816. 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 4-4-2 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
    4-4-20054-8648-165-4-200054-8648-16