Roxicet - 0054-4784-25 - (Oxycodone and Acetaminophen)

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Drug Information of Roxicet

Product NDC: 0054-4784
Proprietary Name: Roxicet
Non Proprietary Name: Oxycodone and Acetaminophen
Active Ingredient(s): 500; 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: 0054-4784
Labeler Name: Roxane Laboratories, Inc.
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: ANDA089775
Marketing Category: ANDA
Start Marketing Date: 19890112

Package Information of Roxicet

Package NDC: 0054-4784-25
Package Description: 100 TABLET in 1 BOTTLE, PLASTIC (0054-4784-25)

NDC Information of Roxicet

NDC Code 0054-4784-25
Proprietary Name Roxicet
Package Description 100 TABLET in 1 BOTTLE, PLASTIC (0054-4784-25)
Product NDC 0054-4784
Product Type Name HUMAN PRESCRIPTION DRUG
Non Proprietary Name Oxycodone and Acetaminophen
Dosage Form Name TABLET
Route Name ORAL
Start Marketing Date 19890112
Marketing Category Name ANDA
Labeler Name Roxane Laboratories, Inc.
Substance Name ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
Strength Number 500; 5
Strength Unit mg/1; mg/1
Pharmaceutical Classes Full Opioid Agonists [MoA],Opioid Agonist [EPC]

Complete Information of Roxicet


General Information