Label: RAMELTEON tablet

  • NDC Code(s): 70771-1495-1, 70771-1495-3, 70771-1495-5
  • Packager: Cadila Healthcare Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated September 8, 2020

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  • SPL UNCLASSIFIED SECTION

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC 70771-1495-3

    Ramelteon Tablets, 8 mg

    30 Tablets

    Rx only

    Ramelteon Tablets
  • INGREDIENTS AND APPEARANCE
    RAMELTEON 
    ramelteon tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1495
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    RAMELTEON (UNII: 901AS54I69) (RAMELTEON - UNII:901AS54I69) RAMELTEON8 mg
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    HYPROMELLOSE 2910 (3 MPA.S) (UNII: 0VUT3PMY82)  
    POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)  
    POVIDONE (UNII: FZ989GH94E)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorYELLOW (light yellow to beige coloured) Scoreno score
    ShapeROUNDSize7mm
    FlavorImprint Code 1344
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1495-330 in 1 BOTTLE; Type 0: Not a Combination Product07/23/2019
    2NDC:70771-1495-1100 in 1 BOTTLE; Type 0: Not a Combination Product07/23/2019
    3NDC:70771-1495-5500 in 1 BOTTLE; Type 0: Not a Combination Product07/23/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21156707/23/2019
    Labeler - Cadila Healthcare Limited (918596198)
    Registrant - Cadila Healthcare Limited (918596198)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cadila Healthcare Limited863362789ANALYSIS(70771-1495) , MANUFACTURE(70771-1495)