Label: MELATONIN RAPID RELEASE GELCAPS 10 MG- melatonin rapid release gelcaps tablet

  • NDC Code(s): 62207-797-38
  • Packager: Granules India Limited
  • Category: BULK INGREDIENT
  • DEA Schedule: None
  • Marketing Status: Export only

Drug Label Information

Updated November 29, 2017

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  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    melatonin 10 mg

  • INGREDIENTS AND APPEARANCE
    MELATONIN RAPID RELEASE GELCAPS 10 MG 
    melatonin rapid release gelcaps tablet
    Product Information
    Product TypeBULK INGREDIENTItem Code (Source)NDC:62207-797
    Route of AdministrationNOT APPLICABLE
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MELATONIN (UNII: JL5DK93RCL) (MELATONIN - UNII:JL5DK93RCL) MELATONIN10 mg
    Inactive Ingredients
    Ingredient NameStrength
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    POVIDONE K30 (UNII: U725QWY32X)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    HYPROMELLOSE 2910 (3 MPA.S) (UNII: 0VUT3PMY82)  
    HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
    GELATIN (UNII: 2G86QN327L)  
    POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    SHELLAC (UNII: 46N107B71O)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    BUTYL ALCOHOL (UNII: 8PJ61P6TS3)  
    AMMONIA (UNII: 5138Q19F1X)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    Product Characteristics
    Colorwhite (blue grey opaque and yellow opaque hard gelatin capsules) Scoreno score
    ShapeCAPSULESize16mm
    FlavorImprint Code G20
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62207-797-3837500 in 1 BOX08/01/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Export only08/01/2017
    Labeler - Granules India Limited (915000087)
    Establishment
    NameAddressID/FEIBusiness Operations
    Granules India Ltd918609236manufacture(62207-797)
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