Label: MEMANTINE HYDROCHLORIDE tablet, film coated

  • NDC Code(s): 70771-1119-0, 70771-1119-1, 70771-1119-2, 70771-1119-4, view more
    70771-1119-5, 70771-1119-6, 70771-1120-0, 70771-1120-1, 70771-1120-2, 70771-1120-4, 70771-1120-5, 70771-1120-6
  • Packager: Cadila Healthcare Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated September 1, 2020

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

  • SPL UNCLASSIFIED SECTION

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC 70771-1119-1 in bottle of 100 tablets

    Memantine Hydrochloride Tablets USP, 5 mg

    Rx only

    100 tablets

    Memantine Hydrochloride Tablets

    NDC 70771-1120-1 in bottle of 100 tablets

    Memantine Hydrochloride Tablets USP, 10 mg

    Rx only

    100 tablets

    Memantine Hydrochloride Tablets
  • INGREDIENTS AND APPEARANCE
    MEMANTINE HYDROCHLORIDE 
    memantine hydrochloride tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1119
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MEMANTINE HYDROCHLORIDE (UNII: JY0WD0UA60) (MEMANTINE - UNII:W8O17SJF3T) MEMANTINE HYDROCHLORIDE5 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POVIDONE (UNII: FZ989GH94E)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    Product Characteristics
    ColorWHITE (WHITE TO OFF-WHITE) Scoreno score
    ShapeCAPSULE (CAPSULE) Size9mm
    FlavorImprint Code ZF;41
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1119-4100 in 1 CARTON09/28/2017
    1NDC:70771-1119-21 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:70771-1119-660 in 1 BOTTLE; Type 0: Not a Combination Product09/28/2017
    3NDC:70771-1119-1100 in 1 BOTTLE; Type 0: Not a Combination Product09/28/2017
    4NDC:70771-1119-5500 in 1 BOTTLE; Type 0: Not a Combination Product09/28/2017
    5NDC:70771-1119-01000 in 1 BOTTLE; Type 0: Not a Combination Product09/28/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09096109/28/2017
    MEMANTINE HYDROCHLORIDE 
    memantine hydrochloride tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1120
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MEMANTINE HYDROCHLORIDE (UNII: JY0WD0UA60) (MEMANTINE - UNII:W8O17SJF3T) MEMANTINE HYDROCHLORIDE10 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POVIDONE (UNII: FZ989GH94E)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    Product Characteristics
    ColorWHITE (WHITE TO OFF-WHITE) Scoreno score
    ShapeCAPSULE (CAPSULE) Size11mm
    FlavorImprint Code ZF;40
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1120-660 in 1 BOTTLE; Type 0: Not a Combination Product09/28/2017
    2NDC:70771-1120-1100 in 1 BOTTLE; Type 0: Not a Combination Product09/28/2017
    3NDC:70771-1120-5500 in 1 BOTTLE; Type 0: Not a Combination Product09/28/2017
    4NDC:70771-1120-01000 in 1 BOTTLE; Type 0: Not a Combination Product09/28/2017
    5NDC:70771-1120-41000 in 1 CARTON09/28/2017
    5NDC:70771-1120-21 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09096109/28/2017
    Labeler - Cadila Healthcare Limited (918596198)
    Registrant - Cadila Healthcare Limited (918596198)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cadila Healthcare Limited918596198ANALYSIS(70771-1119, 70771-1120) , MANUFACTURE(70771-1119, 70771-1120)