NDC 0054-8650 Roxicet

Table of Contents

    1. Product Information
    2. Product Packages
    3. Product Characteristics
    4. What is NDC 0054-8650?
    5. Roxicet Uses
    6. Active Ingredients UNII Codes
    7. Inactive Ingredients UNII Codes
    8. NDC to RxNorm Crosswalk

Product Information

NDC Product Code0054-8650
Proprietary Name What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.		Roxicet
NDC Directory StatusINACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.		West-ward Pharmaceuticals Corp
Labeler Code0054
SPL SET ID:86817b05-450c-4af0-aeea-acba2ac00601
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.		03-11-1987
Listing Expiration Date What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.		12-31-2019
Exclude Flag What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I". 		I
NDC Code Structure

Product Characteristics

Color(s)WHITE (C48325)
ShapeROUND (C48348)
Size(s)11 MM
Imprint(s)54;543
Score2
This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Product Details

What is NDC 0054-8650?

The NDC code 0054-8650 is assigned by the FDA to the product Roxicet which is product labeled by West-ward Pharmaceuticals Corp. The product's dosage form is . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

What are the uses for Roxicet?

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.

Which are Roxicet UNII Codes?

The UNII codes for the active ingredients in this product are:

Which are Roxicet Inactive Ingredients UNII Codes?

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

What is the NDC to RxNorm Crosswalk for Roxicet?

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
  • 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

* Please review the disclaimer below.

Product Label

We have moved the product label and warning information to a dedicated page, please follow the link below:

View Product Label