Label: NATEGLINIDE tablet, film coated

  • NDC Code(s): 70771-1015-0, 70771-1015-1, 70771-1015-2, 70771-1015-3, view more
    70771-1015-4, 70771-1015-5, 70771-1015-9, 70771-1016-0, 70771-1016-1, 70771-1016-2, 70771-1016-3, 70771-1016-4, 70771-1016-5, 70771-1016-9
  • Packager: Zydus Lifesciences Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated October 31, 2022

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  • SPL UNCLASSIFIED SECTION

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC 70771-1015-9 in bottle of 90 tablets

    Nateglinide Tablets USP, 60 mg

    Rx only

    90 tablets

    nateglinide tabs 60 mg

    NDC 70771-1016-9 in bottle of 90 tablets

    Nateglinide Tablets USP, 120 mg

    Rx only

    90 tablets

    nateglinide tabs 120 mg
  • INGREDIENTS AND APPEARANCE
    NATEGLINIDE 
    nateglinide tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1015
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    NATEGLINIDE (UNII: 41X3PWK4O2) (NATEGLINIDE - UNII:41X3PWK4O2) NATEGLINIDE60 mg
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    CROSPOVIDONE (UNII: 2S7830E561)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorWHITE (WHITE TO OFF-WHITE) Scoreno score
    ShapeROUND (ROUND) Size10mm
    FlavorImprint Code 721
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1015-330 in 1 BOTTLE; Type 0: Not a Combination Product10/27/2016
    2NDC:70771-1015-990 in 1 BOTTLE; Type 0: Not a Combination Product10/27/2016
    3NDC:70771-1015-1100 in 1 BOTTLE; Type 0: Not a Combination Product10/27/2016
    4NDC:70771-1015-5500 in 1 BOTTLE; Type 0: Not a Combination Product10/27/2016
    5NDC:70771-1015-01000 in 1 BOTTLE; Type 0: Not a Combination Product10/27/2016
    6NDC:70771-1015-410 in 1 CARTON10/27/2016
    6NDC:70771-1015-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20524810/27/2016
    NATEGLINIDE 
    nateglinide tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1016
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    NATEGLINIDE (UNII: 41X3PWK4O2) (NATEGLINIDE - UNII:41X3PWK4O2) NATEGLINIDE120 mg
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    CROSPOVIDONE (UNII: 2S7830E561)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    POVIDONE (UNII: FZ989GH94E)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorORANGE (LIGHT ORANGE TO ORANGE) Scoreno score
    ShapeOVAL (OVAL) Size18mm
    FlavorImprint Code 722
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1016-330 in 1 BOTTLE; Type 0: Not a Combination Product10/27/2016
    2NDC:70771-1016-990 in 1 BOTTLE; Type 0: Not a Combination Product10/27/2016
    3NDC:70771-1016-1100 in 1 BOTTLE; Type 0: Not a Combination Product10/27/2016
    4NDC:70771-1016-5500 in 1 BOTTLE; Type 0: Not a Combination Product10/27/2016
    5NDC:70771-1016-01000 in 1 BOTTLE; Type 0: Not a Combination Product10/27/2016
    6NDC:70771-1016-410 in 1 CARTON10/27/2016
    6NDC:70771-1016-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20524810/27/2016
    Labeler - Zydus Lifesciences Limited (918596198)
    Registrant - Zydus Lifesciences Limited (918596198)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zydus Lifesciences Limited863362789ANALYSIS(70771-1015, 70771-1016) , MANUFACTURE(70771-1015, 70771-1016)
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