NDC 0054-4650

Roxicet

Oxycodone And Acetaminophen

Roxicet is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by West-ward Pharmaceuticals Corp. The primary component is Oxycodone Hydrochloride; Acetaminophen.

Product ID0054-4650_287496b8-2d45-4949-8194-d540281c2532
NDC0054-4650
Product TypeHuman Prescription Drug
Proprietary NameRoxicet
Generic NameOxycodone And Acetaminophen
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date1991-02-01
Marketing CategoryANDA / ANDA
Application NumberANDA087003
Labeler NameWest-Ward Pharmaceuticals Corp
Substance NameOXYCODONE HYDROCHLORIDE; ACETAMINOPHEN
Active Ingredient Strength5 mg/1; mg/1
Pharm ClassesFull Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA ScheduleCII
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC SPL Data Element Entries

NDC 0054-4650-25 [00054465025]

Roxicet TABLET
Marketing CategoryANDA
Application NumberANDA087003
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1991-02-01
Marketing End Date2014-04-04
Inactivation Date2020-01-31

NDC 0054-4650-29 [00054465029]

Roxicet TABLET
Marketing CategoryANDA
Application NumberANDA087003
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1991-02-01
Marketing End Date2014-04-04
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
OXYCODONE HYDROCHLORIDE5 mg/1

OpenFDA Data

SPL SET ID:86817b05-450c-4af0-aeea-acba2ac00601
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1049221
  • 1049580
  • 1049582
  • 1050490
    • UPC Code
  • 0300543686632
  • 0300544650250

    • Pharmacological Class

    • Full Opioid Agonists [MoA]
    • Opioid Agonist [EPC]

    NDC Crossover Matching brand name "Roxicet" or generic name "Oxycodone And Acetaminophen"

    NDCBrand NameGeneric Name
    0054-3686RoxicetOxycodone and Acetaminophen
    0054-4650RoxicetOxycodone and Acetaminophen
    0054-8648RoxicetOxycodone and Acetaminophen
    0054-8650RoxicetOxycodone and Acetaminophen
    0054-0551Oxycodone and AcetaminophenOxycodone and Acetaminophen
    0228-2981Oxycodone and AcetaminophenOxycodone and Acetaminophen
    0228-2982Oxycodone and AcetaminophenOxycodone and Acetaminophen
    0228-2983Oxycodone and AcetaminophenOxycodone and Acetaminophen
    0527-1669Oxycodone and AcetaminophenOxycodone and Acetaminophen
    0527-1671Oxycodone and AcetaminophenOxycodone and Acetaminophen
    0904-7093OXYCODONE AND ACETAMINOPHENoxycodone and acetaminophen
    0904-7094OXYCODONE AND ACETAMINOPHENoxycodone and acetaminophen
    0904-7095OXYCODONE AND ACETAMINOPHENoxycodone and acetaminophen
    10544-621Oxycodone and AcetaminophenOxycodone and Acetaminophen
    10702-184Oxycodone and AcetaminophenOxycodone and Acetaminophen
    10702-185Oxycodone and AcetaminophenOxycodone and Acetaminophen
    10702-186Oxycodone and AcetaminophenOxycodone and Acetaminophen
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