Label: ASENAPINE MALEATE tablet

  • NDC Code(s): 64330-625-01
  • Packager: Centaur Pharmaceuticals Private Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated November 27, 2020

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

  • SPL UNCLASSIFIED SECTION

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    image
  • INGREDIENTS AND APPEARANCE
    ASENAPINE MALEATE 
    asenapine maleate tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:64330-625
    Route of AdministrationSUBLINGUAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASENAPINE MALEATE (UNII: CU9463U2E2) (ASENAPINE - UNII:JKZ19V908O) ASENAPINE2.5 
    Inactive Ingredients
    Ingredient NameStrength
    ASPARTAME (UNII: Z0H242BBR1)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSPOVIDONE (120 .MU.M) (UNII: 68401960MK)  
    LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 2165RE0K14)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POVIDONE K30 (UNII: U725QWY32X)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeROUNDSize3mm
    FlavorCHERRY (black cherry) Imprint Code B;5
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64330-625-0160 in 1 BOX; Type 0: Not a Combination Product12/10/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20596012/10/2020
    Labeler - Centaur Pharmaceuticals Private Limited (918629361)
    Registrant - Centaur Pharmaceuticals Private Limited (918629361)
    Establishment
    NameAddressID/FEIBusiness Operations
    Centaur Pharmaceuticals Private Limited675596622MANUFACTURE(64330-625) , ANALYSIS(64330-625) , PACK(64330-625)