Label: GABAPENTIN tablet, film coated

  • NDC Code(s): 65841-705-01, 65841-705-05, 65841-705-10, 65841-706-01, view more
    65841-706-05, 65841-706-10, 65841-706-77
  • Packager: Zydus Lifesciences Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated September 26, 2023

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  • MEDICATION GUIDE

    Manufactured by:

    Cadila Heathcare Ltd.

    India

  • SPL MEDGUIDE

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC 65841-705-01 in bottle of 100 tablets

    Gabapentin Tablets USP, 600 mg

    Rx only

    100 tablets

    Gabapentin tablets

    NDC 65841-706-01 in bottle of 100 tablets

    Gabapentin Tablets USP, 800 mg

    Rx only

    100 tablets

    Gabapentin tablets
  • INGREDIENTS AND APPEARANCE
    GABAPENTIN 
    gabapentin tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-705
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GABAPENTIN (UNII: 6CW7F3G59X) (GABAPENTIN - UNII:6CW7F3G59X) GABAPENTIN600 mg
    Inactive Ingredients
    Ingredient NameStrength
    COPOVIDONE K25-31 (UNII: D9C330MD8B)  
    HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED (UNII: 2165RE0K14)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MANNITOL (UNII: 3OWL53L36A)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    POVIDONE (UNII: FZ989GH94E)  
    TALC (UNII: 7SEV7J4R1U)  
    Product Characteristics
    ColorWHITE (WHITE TO OFF-WHITE) Score2 pieces
    ShapeOVAL (OVAL) Size17mm
    FlavorImprint Code ZE72
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-705-01100 in 1 BOTTLE; Type 0: Not a Combination Product10/16/2012
    2NDC:65841-705-05500 in 1 BOTTLE; Type 0: Not a Combination Product10/16/2012
    3NDC:65841-705-101000 in 1 BOTTLE; Type 0: Not a Combination Product10/16/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07892610/16/2012
    GABAPENTIN 
    gabapentin tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-706
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GABAPENTIN (UNII: 6CW7F3G59X) (GABAPENTIN - UNII:6CW7F3G59X) GABAPENTIN800 mg
    Inactive Ingredients
    Ingredient NameStrength
    COPOVIDONE K25-31 (UNII: D9C330MD8B)  
    HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED (UNII: 2165RE0K14)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MANNITOL (UNII: 3OWL53L36A)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    POVIDONE (UNII: FZ989GH94E)  
    TALC (UNII: 7SEV7J4R1U)  
    Product Characteristics
    ColorWHITE (WHITE TO OFF-WHITE) Score2 pieces
    ShapeOVAL (OVAL) Size20mm
    FlavorImprint Code ZE71
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-706-01100 in 1 BOTTLE; Type 0: Not a Combination Product10/16/2012
    2NDC:65841-706-05500 in 1 BOTTLE; Type 0: Not a Combination Product10/16/2012
    3NDC:65841-706-101000 in 1 BOTTLE; Type 0: Not a Combination Product10/16/2012
    4NDC:65841-706-7710 in 1 CARTON10/16/2012
    410 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07892610/16/2012
    Labeler - Zydus Lifesciences Limited (918596198)
    Registrant - Zydus Lifesciences Limited (918596198)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zydus Lifesciences Limited918596198ANALYSIS(65841-705, 65841-706) , MANUFACTURE(65841-705, 65841-706)
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