Label: OXYCODONE APAP- oxycodone apap tablet

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: CII
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated March 14, 2018

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  • DESCRIPTION
  • CLINICAL PHARMACOLOGY
  • INDICATIONS AND USAGE
  • CONTRAINDICATIONS
  • WARNINGS
  • PRECAUTIONS
  • ADVERSE REACTIONS
  • DRUG ABUSE AND DEPENDENCE
  • OVERDOSAGE
  • DOSAGE AND ADMINISTRATION
  • INGREDIENTS AND APPEARANCE
    OXYCODONE APAP 
    oxycodone apap tablet
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:61919-412(NDC:13107-045)
    Route of Administration ORAL DEA Schedule CII    
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    OXYCODONE HYDROCHLORIDE (UNII: C1ENJ2TE6C) (OXYCODONE - UNII:CD35PMG570) OXYCODONE HYDROCHLORIDE 7.5 mg
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg
    Inactive Ingredients
    Ingredient Name Strength
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POVIDONES (UNII: FZ989GH94E)  
    CROSPOVIDONE (UNII: 68401960MK)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    Color white (OFF WHITE) Score no score
    Shape OVAL Size 16mm
    Flavor Imprint Code U16
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:61919-412-30 30 in 1 BOTTLE; Type 0: Not a Combination Product 03/14/2018
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA201972 03/14/2018
    Labeler - DIRECT RX (079254320)
    Establishment
    Name Address ID/FEI Business Operations
    DIRECT RX 079254320 repack(61919-412)
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