Roxicet - 0054-3686-63 - (Oxycodone and Acetaminophen)

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Drug Information of Roxicet

Product NDC: 0054-3686
Proprietary Name: Roxicet
Non Proprietary Name: Oxycodone and Acetaminophen
Active Ingredient(s): 325; 5    mg/5mL; mg/5mL & nbsp;   Oxycodone and Acetaminophen
Administration Route(s): ORAL
Dosage Form(s): SOLUTION
Coding System: National Drug Codes(NDC)

Labeler Information of Roxicet

Product NDC: 0054-3686
Labeler Name: Roxane Laboratories, Inc.
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: ANDA089351
Marketing Category: ANDA
Start Marketing Date: 19861203

Package Information of Roxicet

Package NDC: 0054-3686-63
Package Description: 500 mL in 1 BOTTLE, PLASTIC (0054-3686-63)

NDC Information of Roxicet

NDC Code 0054-3686-63
Proprietary Name Roxicet
Package Description 500 mL in 1 BOTTLE, PLASTIC (0054-3686-63)
Product NDC 0054-3686
Product Type Name HUMAN PRESCRIPTION DRUG
Non Proprietary Name Oxycodone and Acetaminophen
Dosage Form Name SOLUTION
Route Name ORAL
Start Marketing Date 19861203
Marketing Category Name ANDA
Labeler Name Roxane Laboratories, Inc.
Substance Name ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
Strength Number 325; 5
Strength Unit mg/5mL; mg/5mL
Pharmaceutical Classes Full Opioid Agonists [MoA],Opioid Agonist [EPC]

Complete Information of Roxicet


General Information