Label: MEMANTINE HYDROCHLORIDE capsule, extended release

  • NDC Code(s): 70771-1321-2, 70771-1321-3, 70771-1321-4, 70771-1321-9, view more
    70771-1322-2, 70771-1322-3, 70771-1322-4, 70771-1322-9, 70771-1323-2, 70771-1323-3, 70771-1323-4, 70771-1323-9, 70771-1324-2, 70771-1324-3, 70771-1324-4, 70771-1324-9
  • 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

    Memantine Hydrochloride Extended-release Capsules, 7 mg

    NDC 70771-1321-3

    30 Counts

    Memantine Hydrochloride Extended-Release Capsules, 7 mg

    Memantine Hydrochloride Extended-release Capsules, 14 mg

    70771-1322-3

    30 Counts

    Memantine Hydrochloride Extended-Release Capsules, 14 mg

    Memantine Hydrochloride Extended-release Capsules, 21 mg

    NDC 70771-1323-3

    30 Counts

    Memantine Hydrochloride Extended-release Capsules, 21 mg

    Memantine Hydrochloride Extended-release Capsules, 28 mg

    NDC 70771-1324-3

    30 Counts

    Memantine Hydrochloride Extended-release Capsules, 28 mg
  • INGREDIENTS AND APPEARANCE
    MEMANTINE HYDROCHLORIDE 
    memantine hydrochloride capsule, extended release
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1321
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MEMANTINE HYDROCHLORIDE (UNII: JY0WD0UA60) (MEMANTINE - UNII:W8O17SJF3T) MEMANTINE HYDROCHLORIDE7 mg
    Inactive Ingredients
    Ingredient NameStrength
    AMMONIA (UNII: 5138Q19F1X)  
    ALCOHOL (UNII: 3K9958V90M)  
    BUTYL ALCOHOL (UNII: 8PJ61P6TS3)  
    ETHYLCELLULOSE (7 MPA.S) (UNII: H3UP11403C)  
    GELATIN (UNII: 2G86QN327L)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHELLAC (UNII: 46N107B71O)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SUCROSE (UNII: C151H8M554)  
    TALC (UNII: 7SEV7J4R1U)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorWHITE (WHITE) , WHITE (WHITE) Scoreno score
    ShapeCAPSULE (CAPSULE) Size14mm
    FlavorImprint Code 546
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1321-330 in 1 BOTTLE; Type 0: Not a Combination Product04/08/2018
    2NDC:70771-1321-990 in 1 BOTTLE; Type 0: Not a Combination Product04/08/2018
    3NDC:70771-1321-410 in 1 CARTON04/08/2018
    3NDC:70771-1321-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20329304/08/2018
    MEMANTINE HYDROCHLORIDE 
    memantine hydrochloride capsule, extended release
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1322
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MEMANTINE HYDROCHLORIDE (UNII: JY0WD0UA60) (MEMANTINE - UNII:W8O17SJF3T) MEMANTINE HYDROCHLORIDE14 mg
    Inactive Ingredients
    Ingredient NameStrength
    AMMONIA (UNII: 5138Q19F1X)  
    ALCOHOL (UNII: 3K9958V90M)  
    BUTYL ALCOHOL (UNII: 8PJ61P6TS3)  
    ETHYLCELLULOSE (7 MPA.S) (UNII: H3UP11403C)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 3 (UNII: PN2ZH5LOQY)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    GELATIN (UNII: 2G86QN327L)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHELLAC (UNII: 46N107B71O)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SUCROSE (UNII: C151H8M554)  
    TALC (UNII: 7SEV7J4R1U)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorBLUE (LIGHT-BLUE) , GREEN (GREEN) Scoreno score
    ShapeCAPSULE (CAPSULE) Size14mm
    FlavorImprint Code 547
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1322-330 in 1 BOTTLE; Type 0: Not a Combination Product04/08/2018
    2NDC:70771-1322-990 in 1 BOTTLE; Type 0: Not a Combination Product04/08/2018
    3NDC:70771-1322-410 in 1 CARTON04/08/2018
    3NDC:70771-1322-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20329304/08/2018
    MEMANTINE HYDROCHLORIDE 
    memantine hydrochloride capsule, extended release
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1323
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MEMANTINE HYDROCHLORIDE (UNII: JY0WD0UA60) (MEMANTINE - UNII:W8O17SJF3T) MEMANTINE HYDROCHLORIDE21 mg
    Inactive Ingredients
    Ingredient NameStrength
    AMMONIA (UNII: 5138Q19F1X)  
    ALCOHOL (UNII: 3K9958V90M)  
    BUTYL ALCOHOL (UNII: 8PJ61P6TS3)  
    ETHYLCELLULOSE (7 MPA.S) (UNII: H3UP11403C)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    GELATIN (UNII: 2G86QN327L)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHELLAC (UNII: 46N107B71O)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SUCROSE (UNII: C151H8M554)  
    TALC (UNII: 7SEV7J4R1U)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorWHITE (WHITE) , GREEN (GREEN) Scoreno score
    ShapeCAPSULE (CAPSULE) Size14mm
    FlavorImprint Code 548
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1323-330 in 1 BOTTLE; Type 0: Not a Combination Product04/08/2018
    2NDC:70771-1323-990 in 1 BOTTLE; Type 0: Not a Combination Product04/08/2018
    3NDC:70771-1323-410 in 1 CARTON04/08/2018
    3NDC:70771-1323-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20329304/08/2018
    MEMANTINE HYDROCHLORIDE 
    memantine hydrochloride capsule, extended release
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1324
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MEMANTINE HYDROCHLORIDE (UNII: JY0WD0UA60) (MEMANTINE - UNII:W8O17SJF3T) MEMANTINE HYDROCHLORIDE28 mg
    Inactive Ingredients
    Ingredient NameStrength
    AMMONIA (UNII: 5138Q19F1X)  
    ALCOHOL (UNII: 3K9958V90M)  
    BUTYL ALCOHOL (UNII: 8PJ61P6TS3)  
    ETHYLCELLULOSE (7 MPA.S) (UNII: H3UP11403C)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    GELATIN (UNII: 2G86QN327L)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHELLAC (UNII: 46N107B71O)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SUCROSE (UNII: C151H8M554)  
    TALC (UNII: 7SEV7J4R1U)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorGREEN (LIGHT-GREEN) , GREEN (LIGHT-GREEN) Scoreno score
    ShapeCAPSULE (CAPSULE) Size16mm
    FlavorImprint Code 549
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1324-330 in 1 BOTTLE; Type 0: Not a Combination Product04/08/2018
    2NDC:70771-1324-990 in 1 BOTTLE; Type 0: Not a Combination Product04/08/2018
    3NDC:70771-1324-410 in 1 CARTON04/08/2018
    3NDC:70771-1324-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20329304/08/2018
    Labeler - Cadila Healthcare Limited (918596198)
    Registrant - Cadila Healthcare Limited (918596198)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cadila Healthcare Limited918596198ANALYSIS(70771-1321, 70771-1322, 70771-1323, 70771-1324) , MANUFACTURE(70771-1321, 70771-1322, 70771-1323, 70771-1324)