Roxicet - 0054-4650-29 - (Oxycodone and Acetaminophen)

Alphabetical Index


Drug Information of Roxicet

Product NDC: 0054-4650
Proprietary Name: Roxicet
Non Proprietary Name: Oxycodone and Acetaminophen
Active Ingredient(s): 325; 5    mg/1; mg/1 & nbsp;   Oxycodone and Acetaminophen
Administration Route(s): ORAL
Dosage Form(s): TABLET
Coding System: National Drug Codes(NDC)

Labeler Information of Roxicet

Product NDC: 0054-4650
Labeler Name: Roxane Laboratories, Inc.
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: ANDA087003
Marketing Category: ANDA
Start Marketing Date: 19910201

Package Information of Roxicet

Package NDC: 0054-4650-29
Package Description: 500 TABLET in 1 BOTTLE, PLASTIC (0054-4650-29)

NDC Information of Roxicet

NDC Code 0054-4650-29
Proprietary Name Roxicet
Package Description 500 TABLET in 1 BOTTLE, PLASTIC (0054-4650-29)
Product NDC 0054-4650
Product Type Name HUMAN PRESCRIPTION DRUG
Non Proprietary Name Oxycodone and Acetaminophen
Dosage Form Name TABLET
Route Name ORAL
Start Marketing Date 19910201
Marketing Category Name ANDA
Labeler Name Roxane Laboratories, Inc.
Substance Name ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
Strength Number 325; 5
Strength Unit mg/1; mg/1
Pharmaceutical Classes Full Opioid Agonists [MoA],Opioid Agonist [EPC]

Complete Information of Roxicet


General Information