NABUMETONE TABLET, FILM COATED [DIRECT RX]

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NABUMETONE TABLET, FILM COATED [DIRECT RX]
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NDC 61919-159-90, 61919-626-60
Set ID 2d8f206e-0853-43ca-e054-00144ff8d46c
Category HUMAN PRESCRIPTION DRUG LABEL
Packager DIRECT RX
Generic Name
Product Class
Product Number
Application Number ANDA075189
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  • BOXED WARNING (What is this?)

    BOXED WARNING

  • DESCRIPTION

  • CLINICAL PHARMACOLOGY

  • CLINICAL TRIALS

  • INDICATIONS AND USAGE

  • CONTRAINDICATIONS

  • WARNINGS Cardiovascular

  • PRECAUTIONS

  • ADVERSE REACTIONS

  • OVERDOSAGE

  • DOSAGE AND ADMINISTRATION

  • MEDICATION GUIDE

  • Package/Label Display Panel

    NABUMETONE 500mg

  • PRINCIPAL DISPLAY PANEL

    626-60

  • INGREDIENTS AND APPEARANCE
    NABUMETONE 
    nabumetone tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:61919-159(NDC:0093-1015)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    NABUMETONE (UNII: LW0TIW155Z) (NABUMETONE - UNII:LW0TIW155Z) NABUMETONE500 mg
    Inactive Ingredients
    Ingredient NameStrength
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)  
    HYPROMELLOSE 2910 (3 MPA.S) (UNII: 0VUT3PMY82)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4)  
    TALC (UNII: 7SEV7J4R1U)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeOVALSize18mm
    FlavorImprint Code 93;15
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61919-159-9090 in 1 BOTTLE; Type 0: Not a Combination Product03/03/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07518903/03/2016
    NABUMETONE 
    nabumetone tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:61919-626(NDC:0591-3670)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    NABUMETONE (UNII: LW0TIW155Z) (NABUMETONE - UNII:LW0TIW155Z) NABUMETONE500 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIACETIN (UNII: XHX3C3X673)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POVIDONE (UNII: FZ989GH94E)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    TALC (UNII: 7SEV7J4R1U)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeOVALSize17mm
    FlavorImprint Code 3670
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61919-626-6060 in 1 BOTTLE; Type 0: Not a Combination Product03/07/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09108303/07/2019
    Labeler - DIRECT RX (079254320)
    Establishment
    NameAddressID/FEIBusiness Operations
    DIRECT RX079254320repack(61919-159, 61919-626)
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