Label: GABAPENTIN capsule

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated February 10, 2021

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  • HOW SUPPLIED

    300 mg Capsules (Yellow/Yellow colored, size '1' hard gelatin capsules with "104" printed on body of capsules containing white to off white granular powder Bottles of 7 NDC 68071-3230-7

    Bottles of 14 NDC 68071-3230-5

    Bottles of 30 NDC 68071-3230-3

    Bottles of 60 NDC 68071-3230-6

    Bottles of 84 NDC 68071-3230-4

    Bottles of 90 NDC 68071-3230-9

    Bottles of 120 NDC 68071-3230-1

    Bottles of 180 NDC 68071-3230-8

    Bottles of 270 NDC 68071-3230-2

  • 300mg Gabapentin Capsule Package Label

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  • INGREDIENTS AND APPEARANCE
    GABAPENTIN 
    gabapentin capsule
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:68071-3230(NDC:49483-606)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GABAPENTIN (UNII: 6CW7F3G59X) (GABAPENTIN - UNII:6CW7F3G59X) GABAPENTIN300 mg
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    TALC (UNII: 7SEV7J4R1U)  
    GELATIN (UNII: 2G86QN327L)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHELLAC (UNII: 46N107B71O)  
    Product Characteristics
    ColoryellowScoreno score
    ShapeCAPSULESize19mm
    FlavorImprint Code 104
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68071-3230-77 in 1 BOTTLE; Type 0: Not a Combination Product05/19/2017
    2NDC:68071-3230-514 in 1 BOTTLE; Type 0: Not a Combination Product05/19/2017
    3NDC:68071-3230-330 in 1 BOTTLE; Type 0: Not a Combination Product05/19/2017
    4NDC:68071-3230-660 in 1 BOTTLE; Type 0: Not a Combination Product05/19/2017
    5NDC:68071-3230-484 in 1 BOTTLE; Type 0: Not a Combination Product05/19/2017
    6NDC:68071-3230-990 in 1 BOTTLE; Type 0: Not a Combination Product05/19/2017
    7NDC:68071-3230-1120 in 1 BOTTLE; Type 0: Not a Combination Product05/19/2017
    8NDC:68071-3230-8180 in 1 BOTTLE; Type 0: Not a Combination Product05/19/2017
    9NDC:68071-3230-2270 in 1 BOTTLE; Type 0: Not a Combination Product05/19/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09000712/30/2015
    Labeler - NuCare Pharmaceuticals, Inc. (010632300)
    Establishment
    NameAddressID/FEIBusiness Operations
    NuCare Pharmaceuticals, Inc.010632300repack(68071-3230)
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