Label: GABAPENTIN capsule

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

Drug Label Information

Updated November 13, 2018

If you are a consumer or patient please visit this version.

  • HOW SUPPLIED

    100 mg Capsules (White/White colored, size '3' hard gelatin capsules with "103" printed on body of capsules containing white to off white granular powder)

    NDC: 60760-0605-60 BOTTLE OF 60

    60760-0605-90 BOTTLE OF 90

    60760-0605-30 BOTTLE OF 30

  • MEDICATION GUIDE

  • 100 mg Gabapentin Capsule Package Labels

    gab

  • INGREDIENTS AND APPEARANCE
    GABAPENTIN 
    gabapentin capsule
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:60760-605(NDC:49483-605)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GABAPENTIN (UNII: 6CW7F3G59X) (GABAPENTIN - UNII:6CW7F3G59X) GABAPENTIN100 mg
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    TALC (UNII: 7SEV7J4R1U)  
    GELATIN (UNII: 2G86QN327L)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHELLAC (UNII: 46N107B71O)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeCAPSULESize16mm
    FlavorImprint Code 103
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60760-605-9090 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/26/2017
    2NDC:60760-605-6060 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/29/2017
    3NDC:60760-605-3030 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/13/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09000712/26/2017
    Labeler - St. Mary’s Medical Park Pharmacy (063050751)
    Establishment
    NameAddressID/FEIBusiness Operations
    St. Mary’s Medical Park Pharmacy063050751repack(60760-605) , relabel(60760-605)
    Establishment
    NameAddressID/FEIBusiness Operations
    MARKSANS PHARMA LIMITED925822975manufacture(60760-605)