Label: SIMVASTATIN tablet, film coated

  • NDC Code(s): 65841-065-05, 65841-065-06, 65841-065-10, 65841-065-14, view more
    65841-065-16, 65841-066-05, 65841-066-06, 65841-066-10, 65841-066-14, 65841-066-16, 65841-066-24, 65841-067-05, 65841-067-06, 65841-067-10, 65841-067-14, 65841-067-16, 65841-067-24, 65841-068-05, 65841-068-06, 65841-068-10, 65841-068-14, 65841-068-16, 65841-068-40, 65841-069-05, 65841-069-06, 65841-069-10, 65841-069-14, 65841-069-16
  • Packager: Cadila Healthcare Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated September 14, 2020

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

  • SPL UNCLASSIFIED SECTION

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC 65841-065-16 in bottle of 90 tablets

    Simvastatin Tablets USP, 5 mg

    Rx only

    Simvastatin tablets 5 mg

    NDC 65841-066-16 in bottle of 90 tablets

    Simvastatin Tablets USP, 10 mg

    Rx only

    Simvastatin tablets 10 mg

    NDC 65841-067-16 in bottle of 90 tablets

    Simvastatin Tablets USP, 20 mg

    Rx only

    Simvastatin tablets 20 mg

    NDC 65841-068-16 in bottle of 90 tablets

    Simvastatin Tablets USP, 40 mg

    Rx only

    Simvastatin tablets 40 mg

    NDC 65841-069-16 in bottle of 90 tablets

    Simvastatin Tablets USP, 80 mg

    Rx only

    Simvastatin tablets 80 mg
  • INGREDIENTS AND APPEARANCE
    SIMVASTATIN 
    simvastatin tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-065
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SIMVASTATIN (UNII: AGG2FN16EV) (SIMVASTATIN - UNII:AGG2FN16EV) SIMVASTATIN5 mg
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorWHITE (WHITE) Scoreno score
    ShapeOVAL (OVAL) Size9mm
    FlavorImprint Code ZA19
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-065-0630 in 1 BOTTLE; Type 0: Not a Combination Product12/20/2006
    2NDC:65841-065-1460 in 1 BOTTLE; Type 0: Not a Combination Product12/20/2006
    3NDC:65841-065-1690 in 1 BOTTLE; Type 0: Not a Combination Product12/20/2006
    4NDC:65841-065-05500 in 1 BOTTLE; Type 0: Not a Combination Product12/20/2006
    5NDC:65841-065-101000 in 1 BOTTLE; Type 0: Not a Combination Product12/20/2006
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07783712/20/2006
    SIMVASTATIN 
    simvastatin tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-066
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SIMVASTATIN (UNII: AGG2FN16EV) (SIMVASTATIN - UNII:AGG2FN16EV) SIMVASTATIN10 mg
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorPINK (PINK) Scoreno score
    ShapeOVAL (OVAL) Size9mm
    FlavorImprint Code ZA20
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-066-0630 in 1 BOTTLE; Type 0: Not a Combination Product12/20/2006
    2NDC:65841-066-1460 in 1 BOTTLE; Type 0: Not a Combination Product12/20/2006
    3NDC:65841-066-1690 in 1 BOTTLE; Type 0: Not a Combination Product12/20/2006
    4NDC:65841-066-05500 in 1 BOTTLE; Type 0: Not a Combination Product12/20/2006
    5NDC:65841-066-101000 in 1 BOTTLE; Type 0: Not a Combination Product12/20/2006
    6NDC:65841-066-2410000 in 1 BOTTLE; Type 0: Not a Combination Product12/20/2006
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07783712/20/2006
    SIMVASTATIN 
    simvastatin tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-067
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SIMVASTATIN (UNII: AGG2FN16EV) (SIMVASTATIN - UNII:AGG2FN16EV) SIMVASTATIN20 mg
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorBROWN (BROWN) Scoreno score
    ShapeOVAL (OVAL) Size11mm
    FlavorImprint Code ZA21
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-067-0630 in 1 BOTTLE; Type 0: Not a Combination Product12/20/2006
    2NDC:65841-067-1460 in 1 BOTTLE; Type 0: Not a Combination Product12/20/2006
    3NDC:65841-067-1690 in 1 BOTTLE; Type 0: Not a Combination Product12/20/2006
    4NDC:65841-067-05500 in 1 BOTTLE; Type 0: Not a Combination Product12/20/2006
    5NDC:65841-067-101000 in 1 BOTTLE; Type 0: Not a Combination Product12/20/2006
    6NDC:65841-067-2410000 in 1 BOTTLE; Type 0: Not a Combination Product12/20/2006
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07783712/20/2006
    SIMVASTATIN 
    simvastatin tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-068
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SIMVASTATIN (UNII: AGG2FN16EV) (SIMVASTATIN - UNII:AGG2FN16EV) SIMVASTATIN40 mg
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorPINK (PINK) Scoreno score
    ShapeOVAL (OVAL) Size14mm
    FlavorImprint Code ZA22
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-068-0630 in 1 BOTTLE; Type 0: Not a Combination Product12/20/2006
    2NDC:65841-068-1460 in 1 BOTTLE; Type 0: Not a Combination Product12/20/2006
    3NDC:65841-068-1690 in 1 BOTTLE; Type 0: Not a Combination Product12/20/2006
    4NDC:65841-068-05500 in 1 BOTTLE; Type 0: Not a Combination Product12/20/2006
    5NDC:65841-068-101000 in 1 BOTTLE; Type 0: Not a Combination Product12/20/2006
    6NDC:65841-068-405000 in 1 BOTTLE; Type 0: Not a Combination Product12/20/2006
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07783712/20/2006
    SIMVASTATIN 
    simvastatin tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-069
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SIMVASTATIN (UNII: AGG2FN16EV) (SIMVASTATIN - UNII:AGG2FN16EV) SIMVASTATIN80 mg
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorWHITE (WHITE TO OFF-WHITE) Scoreno score
    ShapeCAPSULE (CAPSULE) Size18mm
    FlavorImprint Code ZA23
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-069-0630 in 1 BOTTLE; Type 0: Not a Combination Product12/20/2006
    2NDC:65841-069-1460 in 1 BOTTLE; Type 0: Not a Combination Product12/20/2006
    3NDC:65841-069-1690 in 1 BOTTLE; Type 0: Not a Combination Product12/20/2006
    4NDC:65841-069-05500 in 1 BOTTLE; Type 0: Not a Combination Product12/20/2006
    5NDC:65841-069-101000 in 1 BOTTLE; Type 0: Not a Combination Product12/20/2006
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07783712/20/2006
    Labeler - Cadila Healthcare Limited (918596198)
    Registrant - Cadila Healthcare Limited (918596198)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cadila Healthcare Limited918596198ANALYSIS(65841-065, 65841-066, 65841-067, 65841-068, 65841-069) , MANUFACTURE(65841-065, 65841-066, 65841-067, 65841-068, 65841-069)