Label: ROPINIROLE HYDROCHLORIDE tablet, film coated

  • NDC Code(s): 65841-712-01, 65841-712-10, 65841-713-01, 65841-713-10, view more
    65841-714-01, 65841-714-10, 65841-715-01, 65841-715-10, 65841-716-01, 65841-716-10, 65841-717-01, 65841-717-10, 65841-718-01, 65841-718-10
  • 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 65841-712-01 in bottle of 100 tablets

    Ropinirole Hydrochloride Tablets, 0.25 mg

    100 tablets

    ropinirole hcl tablets, 0.25 mg

    NDC 65841-713-01  in bottle of 100 tablets

    Ropinirole Hydrochloride Tablets, 0.5 mg

    100 tablets

    ropinirole hcl tablets, 0.5 mg

    NDC 65841-714-01 in bottle of 100 tablets

    Ropinirole Hydrochloride Tablets, 1 mg

    100 tablets

    ropinirole hcl tablets, 1 mg

    NDC 65841-715-01in bottle of 100 tablets

    Ropinirole Hydrochloride Tablets, 2 mg

    100 tablets

    ropinirole hcl tablets, 2 mg

    NDC 65841-716-01 in bottle of 100 tablets

    Ropinirole Hydrochloride Tablets, 3 mg

    100 tablets

    ropinirole hcl tablets, 3 mg

    NDC 65841-717-01 in bottle of 100 tablets

    Ropinirole Hydrochloride Tablets, 4 mg

    100 tablets

    ropinirole hcl tablets, 4 mg

    NDC 65841-718-01 in bottle of 100 tablets

    Ropinirole Hydrochloride Tablets, 5 mg

    100 tablets

    ropinirole hcl tablets, 5 mg
  • INGREDIENTS AND APPEARANCE
    ROPINIROLE HYDROCHLORIDE 
    ropinirole hydrochloride tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-712
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ROPINIROLE HYDROCHLORIDE (UNII: D7ZD41RZI9) (ROPINIROLE - UNII:030PYR8953) ROPINIROLE0.25 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    Product Characteristics
    ColorWHITE (WHITE) Scoreno score
    ShapeROUND (ROUND) Size7mm
    FlavorImprint Code ZF22
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-712-01100 in 1 BOTTLE; Type 0: Not a Combination Product09/23/2009
    2NDC:65841-712-101000 in 1 BOTTLE; Type 0: Not a Combination Product09/23/2009
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09041109/23/2009
    ROPINIROLE HYDROCHLORIDE 
    ropinirole hydrochloride tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-713
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ROPINIROLE HYDROCHLORIDE (UNII: D7ZD41RZI9) (ROPINIROLE - UNII:030PYR8953) ROPINIROLE0.5 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    Product Characteristics
    ColorYELLOW (YELLOW) Scoreno score
    ShapeROUND (ROUND) Size7mm
    FlavorImprint Code ZF23
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-713-01100 in 1 BOTTLE; Type 0: Not a Combination Product09/23/2009
    2NDC:65841-713-101000 in 1 BOTTLE; Type 0: Not a Combination Product09/23/2009
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09041109/23/2009
    ROPINIROLE HYDROCHLORIDE 
    ropinirole hydrochloride tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-714
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ROPINIROLE HYDROCHLORIDE (UNII: D7ZD41RZI9) (ROPINIROLE - UNII:030PYR8953) ROPINIROLE1 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    Product Characteristics
    ColorGREEN (GREEN) Scoreno score
    ShapeROUND (ROUND) Size7mm
    FlavorImprint Code ZF24
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-714-01100 in 1 BOTTLE; Type 0: Not a Combination Product09/23/2009
    2NDC:65841-714-101000 in 1 BOTTLE; Type 0: Not a Combination Product09/23/2009
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09041109/23/2009
    ROPINIROLE HYDROCHLORIDE 
    ropinirole hydrochloride tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-715
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ROPINIROLE HYDROCHLORIDE (UNII: D7ZD41RZI9) (ROPINIROLE - UNII:030PYR8953) ROPINIROLE2 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    Product Characteristics
    ColorPINK (PINK) Scoreno score
    ShapeROUND (ROUND) Size7mm
    FlavorImprint Code ZF25
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-715-01100 in 1 BOTTLE; Type 0: Not a Combination Product09/23/2009
    2NDC:65841-715-101000 in 1 BOTTLE; Type 0: Not a Combination Product09/23/2009
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09041109/23/2009
    ROPINIROLE HYDROCHLORIDE 
    ropinirole hydrochloride tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-716
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ROPINIROLE HYDROCHLORIDE (UNII: D7ZD41RZI9) (ROPINIROLE - UNII:030PYR8953) ROPINIROLE3 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    CARMINIC ACID (UNII: CID8Z8N95N)  
    Product Characteristics
    ColorPURPLE (PURPLE) Scoreno score
    ShapeROUND (ROUND) Size7mm
    FlavorImprint Code ZF42
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-716-01100 in 1 BOTTLE; Type 0: Not a Combination Product09/23/2009
    2NDC:65841-716-101000 in 1 BOTTLE; Type 0: Not a Combination Product09/23/2009
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09041109/23/2009
    ROPINIROLE HYDROCHLORIDE 
    ropinirole hydrochloride tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-717
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ROPINIROLE HYDROCHLORIDE (UNII: D7ZD41RZI9) (ROPINIROLE - UNII:030PYR8953) ROPINIROLE4 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    Product Characteristics
    ColorBROWN (BROWN) Scoreno score
    ShapeROUND (ROUND) Size7mm
    FlavorImprint Code ZF43
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-717-01100 in 1 BOTTLE; Type 0: Not a Combination Product09/23/2009
    2NDC:65841-717-101000 in 1 BOTTLE; Type 0: Not a Combination Product09/23/2009
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09041109/23/2009
    ROPINIROLE HYDROCHLORIDE 
    ropinirole hydrochloride tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-718
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ROPINIROLE HYDROCHLORIDE (UNII: D7ZD41RZI9) (ROPINIROLE - UNII:030PYR8953) ROPINIROLE5 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    Product Characteristics
    ColorBLUE (BLUE) Scoreno score
    ShapeROUND (ROUND) Size7mm
    FlavorImprint Code ZF26
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-718-01100 in 1 BOTTLE; Type 0: Not a Combination Product09/23/2009
    2NDC:65841-718-101000 in 1 BOTTLE; Type 0: Not a Combination Product09/23/2009
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09041109/23/2009
    Labeler - Cadila Healthcare Limited (918596198)
    Registrant - Cadila Healthcare Limited (918596198)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cadila Healthcare Limited918596198ANALYSIS(65841-712, 65841-713, 65841-714, 65841-715, 65841-716, 65841-717, 65841-718) , MANUFACTURE(65841-712, 65841-713, 65841-714, 65841-715, 65841-716, 65841-717, 65841-718)