0054-8650 NDC - ROXICET (OXYCODONE AND ACETAMINOPHEN)

Drug Information

Product NDC: 0054-8650

Proprietary Name: Roxicet

Non Proprietary Name: Oxycodone and Acetaminophen

Active Ingredient(s):
  • 5 mg/1 OXYCODONE HYDROCHLORIDE;
  • 325 mg/1 ACETAMINOPHEN


Administration Route(s): ORAL

Dosage Form(s): TABLET

Pharmacy Class(es):
  • Full Opioid Agonists [MoA];
  • Opioid Agonist [EPC]

Labeler Information

Labeler Name: West-Ward Pharmaceuticals Corp
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: ANDA087003
Marketing Category: ANDA
Start Marketing Date:3/11/1987
DEA Schedule:CII

Package Information

No. Package Code Package Description Billing Unit

NDC Record

Field Name Field Value Definition
PRODUCT NDC0054-8650The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PRODUCT TYPE NAMEHUMAN PRESCRIPTION DRUGIndicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
PROPRIETARY NAMERoxicetThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEOxycodone and AcetaminophenThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMETABLETThe translation of the dosage form Code submitted by the firm.
ROUTE NAMEORALThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE3/11/1987This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEANDAProduct types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
APPLICATION NUMBERANDA087003This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
LABELER NAMEWest-Ward Pharmaceuticals CorpName of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEOXYCODONE HYDROCHLORIDE; ACETAMINOPHENThis is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
ACTIVE NUMERATOR STRENGTH5; 325 
ACTIVE INGRED UNITmg/1; mg/1 
PHARM CLASSESFull Opioid Agonists [MoA],Opioid Agonist [EPC] 
DEA SCHEDULECIIThis is the assigned DEA Schedule number as reported by the labeler. Values are CI, CII, CIII, CIV, and CV.

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This page was last updated on: 5/17/2019