Label: PRAMIPEXOLE DIHYDROCHLORIDE tablet

  • NDC Code(s): 65841-734-05, 65841-734-10, 65841-734-16, 65841-735-05, view more
    65841-735-10, 65841-735-16, 65841-736-05, 65841-736-10, 65841-736-16, 65841-737-05, 65841-737-10, 65841-737-16, 65841-738-05, 65841-738-10, 65841-738-16
  • Packager: Cadila Healthcare Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL

Drug Label Information

Updated September 8, 2020

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • SPL UNCLASSIFIED SECTION

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC 65841-734-16 in bottle of 90 tablets

    Pramipexole Dihydrochloride Tablets, 0.125 mg

    Rx only

    90 tablets

    Pramipexole Dihydrochloride Tablets, 0.125 mg

    NDC 65841-735-16 in bottle of 90 tablets

    Pramipexole Dihydrochloride Tablets, 0.25 mg

    Rx only

    90 tablets

    Pramipexole Dihydrochloride Tablets, 0.25 mg

    NDC 65841-736-16 in bottle of 90 tablets

    Pramipexole Dihydrochloride Tablets, 0.5 mg

    Rx only

    90 tablets

    Pramipexole Dihydrochloride Tablets , 0.5 mg

    NDC 65841-737-16 in bottle of 90 tablets

    Pramipexole Dihydrochloride Tablets, 1 mg

    Rx only

    90 tablets

    Pramipexole Dihydrochloride Tablets , 1 mg

    NDC 65841-738-16 in bottle of 90 tablets

    Pramipexole Dihydrochloride Tablets, 1.5 mg

    Rx only

    90 tablets

    Pramipexole Dihydrochloride Tablets , 1.5 mmg
  • INGREDIENTS AND APPEARANCE
    PRAMIPEXOLE DIHYDROCHLORIDE 
    pramipexole dihydrochloride tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-734
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PRAMIPEXOLE DIHYDROCHLORIDE (UNII: 3D867NP06J) (PRAMIPEXOLE - UNII:83619PEU5T) PRAMIPEXOLE DIHYDROCHLORIDE0.125 mg
    Inactive Ingredients
    Ingredient NameStrength
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MANNITOL (UNII: 3OWL53L36A)  
    POVIDONE (UNII: FZ989GH94E)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Product Characteristics
    ColorPINK (PINK) Scoreno score
    ShapeCAPSULE (CAPSULE) Size7mm
    FlavorImprint Code P1
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-734-1690 in 1 BOTTLE; Type 0: Not a Combination Product07/10/2010
    2NDC:65841-734-05500 in 1 BOTTLE; Type 0: Not a Combination Product07/10/2010
    3NDC:65841-734-101000 in 1 BOTTLE; Type 0: Not a Combination Product07/10/2010
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07892007/10/2010
    PRAMIPEXOLE DIHYDROCHLORIDE 
    pramipexole dihydrochloride tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-735
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PRAMIPEXOLE DIHYDROCHLORIDE (UNII: 3D867NP06J) (PRAMIPEXOLE - UNII:83619PEU5T) PRAMIPEXOLE DIHYDROCHLORIDE0.25 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MANNITOL (UNII: 3OWL53L36A)  
    POVIDONE (UNII: FZ989GH94E)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Product Characteristics
    ColorBLUE (PALE BLUE) Score2 pieces
    ShapeROUND (ROUND) Size6mm
    FlavorImprint Code P2
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-735-1690 in 1 BOTTLE; Type 0: Not a Combination Product07/10/2010
    2NDC:65841-735-05500 in 1 BOTTLE; Type 0: Not a Combination Product07/10/2010
    3NDC:65841-735-101000 in 1 BOTTLE; Type 0: Not a Combination Product07/10/2010
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07892007/10/2010
    PRAMIPEXOLE DIHYDROCHLORIDE 
    pramipexole dihydrochloride tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-736
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PRAMIPEXOLE DIHYDROCHLORIDE (UNII: 3D867NP06J) (PRAMIPEXOLE - UNII:83619PEU5T) PRAMIPEXOLE DIHYDROCHLORIDE0.5 mg
    Inactive Ingredients
    Ingredient NameStrength
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MANNITOL (UNII: 3OWL53L36A)  
    POVIDONE (UNII: FZ989GH94E)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Product Characteristics
    ColorPURPLE (LAVENDER) Score2 pieces
    ShapeCAPSULE (CAPSULE) Size8mm
    FlavorImprint Code P;3
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-736-1690 in 1 BOTTLE; Type 0: Not a Combination Product07/10/2010
    2NDC:65841-736-05500 in 1 BOTTLE; Type 0: Not a Combination Product07/10/2010
    3NDC:65841-736-101000 in 1 BOTTLE; Type 0: Not a Combination Product07/10/2010
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07892007/10/2010
    PRAMIPEXOLE DIHYDROCHLORIDE 
    pramipexole dihydrochloride tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-737
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PRAMIPEXOLE DIHYDROCHLORIDE (UNII: 3D867NP06J) (PRAMIPEXOLE - UNII:83619PEU5T) PRAMIPEXOLE DIHYDROCHLORIDE1 mg
    Inactive Ingredients
    Ingredient NameStrength
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MANNITOL (UNII: 3OWL53L36A)  
    POVIDONE (UNII: FZ989GH94E)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Product Characteristics
    ColorORANGE (LIGHT PEACH TO PEACH) Score2 pieces
    ShapeROUND (ROUND) Size6mm
    FlavorImprint Code P4
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-737-1690 in 1 BOTTLE; Type 0: Not a Combination Product07/10/2010
    2NDC:65841-737-05500 in 1 BOTTLE; Type 0: Not a Combination Product07/10/2010
    3NDC:65841-737-101000 in 1 BOTTLE; Type 0: Not a Combination Product07/10/2010
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07892007/10/2010
    PRAMIPEXOLE DIHYDROCHLORIDE 
    pramipexole dihydrochloride tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-738
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PRAMIPEXOLE DIHYDROCHLORIDE (UNII: 3D867NP06J) (PRAMIPEXOLE - UNII:83619PEU5T) PRAMIPEXOLE DIHYDROCHLORIDE1.5 mg
    Inactive Ingredients
    Ingredient NameStrength
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MANNITOL (UNII: 3OWL53L36A)  
    POVIDONE (UNII: FZ989GH94E)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Product Characteristics
    ColorYELLOW (YELLOW) Score2 pieces
    ShapeROUND (ROUND) Size7mm
    FlavorImprint Code P5
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-738-1690 in 1 BOTTLE; Type 0: Not a Combination Product07/10/2010
    2NDC:65841-738-05500 in 1 BOTTLE; Type 0: Not a Combination Product07/10/2010
    3NDC:65841-738-101000 in 1 BOTTLE; Type 0: Not a Combination Product07/10/2010
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07892007/10/2010
    Labeler - Cadila Healthcare Limited (918596198)
    Registrant - Cadila Healthcare Limited (918596198)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cadila Healthcare Limited918596198ANALYSIS(65841-734, 65841-735, 65841-736, 65841-737, 65841-738) , MANUFACTURE(65841-734, 65841-735, 65841-736, 65841-737, 65841-738)