Label: PRAMIPEXOLE DIHYDROCHLORIDE tablet, extended release

  • NDC Code(s): 70771-1328-2, 70771-1328-3, 70771-1328-4, 70771-1329-2, view more
    70771-1329-3, 70771-1329-4, 70771-1330-2, 70771-1330-3, 70771-1330-4, 70771-1331-3, 70771-1332-2, 70771-1332-3, 70771-1332-4, 70771-1333-2, 70771-1333-3, 70771-1333-4, 70771-1334-2, 70771-1334-3, 70771-1334-4
  • Packager: Cadila Healthcare Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated September 8, 2020

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

  • SPL UNCLASSIFIED SECTION

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC 70771-1328-3

    Pramipexole Dihydrochloride Extended-release Tablets, 0.375 mg

    Rx only

    30 tablets

    Pramipexole Dihydrochloride ER Tablets

    NDC 70771-1329-3

    Pramipexole Dihydrochloride Extended-release Tablets, 0.75 mg

    Rx only

    30 tablets

    Pramipexole Dihydrochloride ER Tablets image  02

    NDC 70771-1330-3

    Pramipexole Dihydrochloride Extended-release Tablets, 1.5 mg

    Rx only

    30 tablets

    Pramipexole Dihydrochloride ER Tablets image  03

    NDC 70771-1331-3

    Pramipexole Dihydrochloride Extended-release Tablets, 2.25 mg

    Rx only

    30 tablets

    Pramipexole dihydrochloride extended-release tablets

    NDC 70771-1332-3

    Pramipexole Dihydrochloride Extended-release Tablets, 3 mg

    Rx only

    30 tablets

    Pramipexole Dihydrochloride ER Tablets image  04

    NDC 70771-1333-3

    Pramipexole Dihydrochloride Extended-release Tablets, 3.75 mg

    Rx only

    30 tablets

    Pramipexole dihydrochloride extended-release tablets

    NDC 70771-1334-3

    Pramipexole Dihydrochloride Extended-release Tablets, 4.5 mg

    Rx only

    30 tablets

    Pramipexole Dihydrochloride ER Tablets image  05
  • INGREDIENTS AND APPEARANCE
    PRAMIPEXOLE DIHYDROCHLORIDE 
    pramipexole dihydrochloride tablet, extended release
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1328
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PRAMIPEXOLE DIHYDROCHLORIDE (UNII: 3D867NP06J) (PRAMIPEXOLE - UNII:83619PEU5T) PRAMIPEXOLE DIHYDROCHLORIDE0.375 mg
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, CORN (UNII: O8232NY3SJ)  
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MANNITOL (UNII: 3OWL53L36A)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    Product Characteristics
    ColorWHITE (WHITE TO OFF-WHITE) , BROWN (Buff to light brown speckles) Scoreno score
    ShapeOVAL (oval) Size11mm
    FlavorImprint Code 474
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1328-330 in 1 BOTTLE; Type 0: Not a Combination Product04/24/2018
    2NDC:70771-1328-410 in 1 CARTON04/24/2018
    2NDC:70771-1328-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20289104/24/2018
    PRAMIPEXOLE DIHYDROCHLORIDE 
    pramipexole dihydrochloride tablet, extended release
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1329
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PRAMIPEXOLE DIHYDROCHLORIDE (UNII: 3D867NP06J) (PRAMIPEXOLE - UNII:83619PEU5T) PRAMIPEXOLE DIHYDROCHLORIDE0.75 mg
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, CORN (UNII: O8232NY3SJ)  
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MANNITOL (UNII: 3OWL53L36A)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    Product Characteristics
    ColorWHITE (WHITE TO OFF-WHITE) , BROWN (Buff to light brown speckles) Scoreno score
    ShapeOVAL (oval) Size11mm
    FlavorImprint Code 475
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1329-330 in 1 BOTTLE; Type 0: Not a Combination Product04/24/2018
    2NDC:70771-1329-410 in 1 CARTON04/24/2018
    2NDC:70771-1329-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20289104/24/2018
    PRAMIPEXOLE DIHYDROCHLORIDE 
    pramipexole dihydrochloride tablet, extended release
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1330
    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
    STARCH, CORN (UNII: O8232NY3SJ)  
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MANNITOL (UNII: 3OWL53L36A)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    Product Characteristics
    ColorWHITE (WHITE TO OFF-WHITE) , BROWN (Buff to light brown speckles) Scoreno score
    ShapeOVAL (oval) Size13mm
    FlavorImprint Code 476
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1330-330 in 1 BOTTLE; Type 0: Not a Combination Product04/24/2018
    2NDC:70771-1330-410 in 1 CARTON04/24/2018
    2NDC:70771-1330-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20289104/24/2018
    PRAMIPEXOLE DIHYDROCHLORIDE 
    pramipexole dihydrochloride tablet, extended release
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1332
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PRAMIPEXOLE DIHYDROCHLORIDE (UNII: 3D867NP06J) (PRAMIPEXOLE - UNII:83619PEU5T) PRAMIPEXOLE DIHYDROCHLORIDE3 mg
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, CORN (UNII: O8232NY3SJ)  
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MANNITOL (UNII: 3OWL53L36A)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    Product Characteristics
    ColorWHITE (WHITE TO OFF-WHITE) , BROWN (Buff to light brown speckles) Scoreno score
    ShapeOVAL (oval) Size13mm
    FlavorImprint Code 477
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1332-330 in 1 BOTTLE; Type 0: Not a Combination Product04/24/2018
    2NDC:70771-1332-410 in 1 CARTON04/24/2018
    2NDC:70771-1332-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20289104/24/2018
    PRAMIPEXOLE DIHYDROCHLORIDE 
    pramipexole dihydrochloride tablet, extended release
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1334
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PRAMIPEXOLE DIHYDROCHLORIDE (UNII: 3D867NP06J) (PRAMIPEXOLE - UNII:83619PEU5T) PRAMIPEXOLE DIHYDROCHLORIDE4.5 mg
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, CORN (UNII: O8232NY3SJ)  
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MANNITOL (UNII: 3OWL53L36A)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    Product Characteristics
    ColorWHITE (WHITE TO OFF-WHITE) , BROWN (Buff to light brown speckles) Scoreno score
    ShapeOVAL (oval) Size16mm
    FlavorImprint Code 478
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1334-330 in 1 BOTTLE; Type 0: Not a Combination Product04/24/2018
    2NDC:70771-1334-410 in 1 CARTON04/24/2018
    2NDC:70771-1334-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20289104/24/2018
    PRAMIPEXOLE DIHYDROCHLORIDE 
    pramipexole dihydrochloride tablet, extended release
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1331
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PRAMIPEXOLE DIHYDROCHLORIDE (UNII: 3D867NP06J) (PRAMIPEXOLE - UNII:83619PEU5T) PRAMIPEXOLE DIHYDROCHLORIDE2.25 mg
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MANNITOL (UNII: 3OWL53L36A)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    Product Characteristics
    ColorWHITE (OFF-WHITE) Scoreno score
    ShapeOVAL (OVAL) Size13mm
    FlavorImprint Code 874
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1331-330 in 1 BOTTLE; Type 0: Not a Combination Product04/24/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20289104/24/2018
    PRAMIPEXOLE DIHYDROCHLORIDE 
    pramipexole dihydrochloride tablet, extended release
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1333
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PRAMIPEXOLE DIHYDROCHLORIDE (UNII: 3D867NP06J) (PRAMIPEXOLE - UNII:83619PEU5T) PRAMIPEXOLE DIHYDROCHLORIDE3.75 mg
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MANNITOL (UNII: 3OWL53L36A)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    Product Characteristics
    ColorWHITE (OFF-WHITE) Scoreno score
    ShapeOVAL (OVAL) Size13mm
    FlavorImprint Code 875
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1333-330 in 1 BOTTLE; Type 0: Not a Combination Product04/24/2018
    2NDC:70771-1333-410 in 1 CARTON04/24/2018
    2NDC:70771-1333-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20289104/24/2018
    Labeler - Cadila Healthcare Limited (918596198)
    Registrant - Cadila Healthcare Limited (918596198)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cadila Healthcare Limited918596198ANALYSIS(70771-1328, 70771-1329, 70771-1330, 70771-1331, 70771-1332, 70771-1333, 70771-1334) , MANUFACTURE(70771-1328, 70771-1329, 70771-1330, 70771-1331, 70771-1332, 70771-1333, 70771-1334)