Label: PAROXETINE- paroxetine hydrochloride tablet, film coated

  • NDC Code(s): 65841-097-01, 65841-097-05, 65841-097-06, 65841-097-10, view more
    65841-097-16, 65841-098-01, 65841-098-05, 65841-098-06, 65841-098-10, 65841-098-16, 65841-099-01, 65841-099-05, 65841-099-06, 65841-099-10, 65841-099-16, 65841-601-01, 65841-601-05, 65841-601-06, 65841-601-10, 65841-601-16
  • Packager: Cadila Healthcare Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated December 8, 2020

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

  • SPL MEDGUIDE

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC 65841-097-05 in pack count of 500 tablets

    Paroxetine Tablets USP, 10 mg

    Rx only

    500 tablets

    Paroxetine tablets, 10 mg

    NDC 65841-098-16 in pack count of 90 tablets

    Paroxetine Tablets USP, 20 mg

    Rx only

    90 tablets

    Paroxetine tablets, 20 mg

    NDC 65841-099-10 in pack count of 1000 tablets

    Paroxetine Tablets USP, 30 mg

    Rx only

    1000 tablets

    Paroxetine tablets, 30 mg

    NDC 65841-601-06 in pack count of 30 tablets

    Paroxetine Tablets USP, 40 mg

    Rx only

    30 tablets

    Paroxetine tablets, 40 mg
  • INGREDIENTS AND APPEARANCE
    PAROXETINE 
    paroxetine hydrochloride tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-097
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PAROXETINE HYDROCHLORIDE ANHYDROUS (UNII: 3I3T11UD2S) (PAROXETINE - UNII:41VRH5220H, PAROXETINE - UNII:41VRH5220H) PAROXETINE10 mg
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    POVIDONE (UNII: FZ989GH94E)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorWHITE (WHITE TO OFF-WHITE) Score2 pieces
    ShapeROUND (ROUND) Size6mm
    FlavorImprint Code ZC;15
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-097-0630 in 1 BOTTLE; Type 0: Not a Combination Product04/13/2007
    2NDC:65841-097-1690 in 1 BOTTLE; Type 0: Not a Combination Product04/13/2007
    3NDC:65841-097-01100 in 1 BOTTLE; Type 0: Not a Combination Product04/13/2007
    4NDC:65841-097-05500 in 1 BOTTLE; Type 0: Not a Combination Product04/13/2007
    5NDC:65841-097-101000 in 1 BOTTLE; Type 0: Not a Combination Product04/13/2007
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07758404/13/2007
    PAROXETINE 
    paroxetine hydrochloride tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-098
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PAROXETINE HYDROCHLORIDE ANHYDROUS (UNII: 3I3T11UD2S) (PAROXETINE - UNII:41VRH5220H, PAROXETINE - UNII:41VRH5220H) PAROXETINE20 mg
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    POVIDONE (UNII: FZ989GH94E)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorWHITE (WHITE TO OFF-WHITE) Score2 pieces
    ShapeROUND (ROUND) Size8mm
    FlavorImprint Code ZC;16
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-098-0630 in 1 BOTTLE; Type 0: Not a Combination Product04/13/2007
    2NDC:65841-098-1690 in 1 BOTTLE; Type 0: Not a Combination Product04/13/2007
    3NDC:65841-098-01100 in 1 BOTTLE; Type 0: Not a Combination Product04/13/2007
    4NDC:65841-098-05500 in 1 BOTTLE; Type 0: Not a Combination Product04/13/2007
    5NDC:65841-098-101000 in 1 BOTTLE; Type 0: Not a Combination Product04/13/2007
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07758404/13/2007
    PAROXETINE 
    paroxetine hydrochloride tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-099
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PAROXETINE HYDROCHLORIDE ANHYDROUS (UNII: 3I3T11UD2S) (PAROXETINE - UNII:41VRH5220H, PAROXETINE - UNII:41VRH5220H) PAROXETINE30 mg
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    POVIDONE (UNII: FZ989GH94E)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorWHITE (WHITE TO OFF-WHITE) Scoreno score
    ShapeROUND (ROUND) Size10mm
    FlavorImprint Code ZC17
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-099-0630 in 1 BOTTLE; Type 0: Not a Combination Product04/13/2007
    2NDC:65841-099-1690 in 1 BOTTLE; Type 0: Not a Combination Product04/13/2007
    3NDC:65841-099-01100 in 1 BOTTLE; Type 0: Not a Combination Product04/13/2007
    4NDC:65841-099-05500 in 1 BOTTLE; Type 0: Not a Combination Product04/13/2007
    5NDC:65841-099-101000 in 1 BOTTLE; Type 0: Not a Combination Product04/13/2007
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07758404/13/2007
    PAROXETINE 
    paroxetine hydrochloride tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-601
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PAROXETINE HYDROCHLORIDE ANHYDROUS (UNII: 3I3T11UD2S) (PAROXETINE - UNII:41VRH5220H, PAROXETINE - UNII:41VRH5220H) PAROXETINE40 mg
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    POVIDONE (UNII: FZ989GH94E)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorWHITE (WHITE TO OFF-WHITE) Scoreno score
    ShapeROUND (ROUND) Size11mm
    FlavorImprint Code ZC18
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-601-0630 in 1 BOTTLE; Type 0: Not a Combination Product04/13/2007
    2NDC:65841-601-1690 in 1 BOTTLE; Type 0: Not a Combination Product04/13/2007
    3NDC:65841-601-01100 in 1 BOTTLE; Type 0: Not a Combination Product04/13/2007
    4NDC:65841-601-05500 in 1 BOTTLE; Type 0: Not a Combination Product04/13/2007
    5NDC:65841-601-101000 in 1 BOTTLE; Type 0: Not a Combination Product04/13/2007
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07758404/13/2007
    Labeler - Cadila Healthcare Limited (918596198)
    Registrant - Cadila Healthcare Limited (918596198)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cadila Healthcare Limited918596198ANALYSIS(65841-097, 65841-098, 65841-099, 65841-601) , MANUFACTURE(65841-097, 65841-098, 65841-099, 65841-601)
    Establishment
    NameAddressID/FEIBusiness Operations
    CADILA HEALTHCARE LIMITED677605858MANUFACTURE(65841-097, 65841-098, 65841-099, 65841-601)