Label: ATOMOXETINE capsule

  • NDC Code(s): 65841-606-02, 65841-606-06, 65841-606-10, 65841-606-14, view more
    65841-606-16, 65841-607-02, 65841-607-06, 65841-607-10, 65841-607-14, 65841-607-16, 65841-607-30, 65841-607-77, 65841-608-02, 65841-608-06, 65841-608-10, 65841-608-14, 65841-608-16, 65841-608-30, 65841-608-77, 65841-609-02, 65841-609-06, 65841-609-10, 65841-609-14, 65841-609-16, 65841-609-30, 65841-609-77, 65841-610-02, 65841-610-06, 65841-610-10, 65841-610-14, 65841-610-16, 65841-610-30, 65841-610-77, 65841-611-02, 65841-611-06, 65841-611-10, 65841-611-14, 65841-611-16
  • Packager: Cadila Healthcare Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL

Drug Label Information

Updated August 13, 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 65841-606-16 in bottle of 90 Capsules

    Atomoxetine Capsules, 18 mg

    90 Capsules

    Atomoxetine 18 mg

    NDC 65841-607-16 in bottle of 90 Capsules

    Atomoxetine Capsules, 25 mg

    90 Capsules

    Atomoxetine 25 mg

    NDC 65841-608-16 in bottle of 90 Capsules

    Atomoxetine Capsules, 40 mg

    90 Capsules

    Atomoxetine 40 mg

    NDC 65841-609-16 in bottle of 90 Capsules

    Atomoxetine Capsules, 60 mg

    90 Capsules

    Atomoxetine 60 mg

    NDC 65841-610-16 in bottle of 90 Capsules

    Atomoxetine Capsules, 80 mg

    90 Capsules

    Atomoxetine 80 mg

    NDC 65841-611-16 in bottle of 90 Capsules

    Atomoxetine Capsules, 100 mg

    90 Capsules

    Atomoxetine caps 100 mg
  • INGREDIENTS AND APPEARANCE
    ATOMOXETINE 
    atomoxetine capsule
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-606
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ATOMOXETINE HYDROCHLORIDE (UNII: 57WVB6I2W0) (ATOMOXETINE - UNII:ASW034S0B8) ATOMOXETINE18 mg
    Inactive Ingredients
    Ingredient NameStrength
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    GELATIN (UNII: 2G86QN327L)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHELLAC (UNII: 46N107B71O)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorYELLOW (GOLDEN) , WHITE (WHITE) Scoreno score
    ShapeCAPSULE (CAPSULE) Size14mm
    FlavorImprint Code ZA;68
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-606-0630 in 1 BOTTLE; Type 0: Not a Combination Product12/06/2017
    2NDC:65841-606-1460 in 1 BOTTLE; Type 0: Not a Combination Product12/06/2017
    3NDC:65841-606-1690 in 1 BOTTLE; Type 0: Not a Combination Product12/06/2017
    4NDC:65841-606-101000 in 1 BOTTLE; Type 0: Not a Combination Product12/06/2017
    5NDC:65841-606-022000 in 1 BOTTLE; Type 0: Not a Combination Product12/06/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07901712/06/2017
    ATOMOXETINE 
    atomoxetine capsule
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-607
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ATOMOXETINE HYDROCHLORIDE (UNII: 57WVB6I2W0) (ATOMOXETINE - UNII:ASW034S0B8) ATOMOXETINE25 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    GELATIN (UNII: 2G86QN327L)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHELLAC (UNII: 46N107B71O)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorBLUE (OPAQUE BLUE) , WHITE (OPAQUE WHITE) Scoreno score
    ShapeCAPSULE (CAPSULE) Size18mm
    FlavorImprint Code ZA69;25mg
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-607-0630 in 1 BOTTLE; Type 0: Not a Combination Product12/06/2017
    2NDC:65841-607-1460 in 1 BOTTLE; Type 0: Not a Combination Product12/06/2017
    3NDC:65841-607-1690 in 1 BOTTLE; Type 0: Not a Combination Product12/06/2017
    4NDC:65841-607-101000 in 1 BOTTLE; Type 0: Not a Combination Product12/06/2017
    5NDC:65841-607-022000 in 1 BOTTLE; Type 0: Not a Combination Product12/06/2017
    6NDC:65841-607-7710 in 1 CARTON12/06/2017
    6NDC:65841-607-3010 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07901712/06/2017
    ATOMOXETINE 
    atomoxetine capsule
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-608
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ATOMOXETINE HYDROCHLORIDE (UNII: 57WVB6I2W0) (ATOMOXETINE - UNII:ASW034S0B8) ATOMOXETINE40 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    GELATIN (UNII: 2G86QN327L)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SHELLAC (UNII: 46N107B71O)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    Product Characteristics
    ColorBLUE (OPAQUE BLUE) , BLUE (OPAQUE BLUE) Scoreno score
    ShapeCAPSULE (CAPSULE) Size18mm
    FlavorImprint Code ZA70;40mg
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-608-0630 in 1 BOTTLE; Type 0: Not a Combination Product12/06/2017
    2NDC:65841-608-1460 in 1 BOTTLE; Type 0: Not a Combination Product12/06/2017
    3NDC:65841-608-1690 in 1 BOTTLE; Type 0: Not a Combination Product12/06/2017
    4NDC:65841-608-101000 in 1 BOTTLE; Type 0: Not a Combination Product12/06/2017
    5NDC:65841-608-022000 in 1 BOTTLE; Type 0: Not a Combination Product12/06/2017
    6NDC:65841-608-7710 in 1 CARTON12/06/2017
    6NDC:65841-608-3010 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07901712/06/2017
    ATOMOXETINE 
    atomoxetine capsule
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-609
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ATOMOXETINE HYDROCHLORIDE (UNII: 57WVB6I2W0) (ATOMOXETINE - UNII:ASW034S0B8) ATOMOXETINE60 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    GELATIN (UNII: 2G86QN327L)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHELLAC (UNII: 46N107B71O)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorBLUE (OPAQUE BLUE) , YELLOW (GOLDEN) Scoreno score
    ShapeCAPSULE (CAPSULE) Size19mm
    FlavorImprint Code ZA71;60mg
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-609-0630 in 1 BOTTLE; Type 0: Not a Combination Product12/06/2017
    2NDC:65841-609-1460 in 1 BOTTLE; Type 0: Not a Combination Product12/06/2017
    3NDC:65841-609-1690 in 1 BOTTLE; Type 0: Not a Combination Product12/06/2017
    4NDC:65841-609-101000 in 1 BOTTLE; Type 0: Not a Combination Product12/06/2017
    5NDC:65841-609-022000 in 1 BOTTLE; Type 0: Not a Combination Product12/06/2017
    6NDC:65841-609-7710 in 1 CARTON12/06/2017
    6NDC:65841-609-3010 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07901712/06/2017
    ATOMOXETINE 
    atomoxetine capsule
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-610
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ATOMOXETINE HYDROCHLORIDE (UNII: 57WVB6I2W0) (ATOMOXETINE - UNII:ASW034S0B8) ATOMOXETINE80 mg
    Inactive Ingredients
    Ingredient NameStrength
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    GELATIN (UNII: 2G86QN327L)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHELLAC (UNII: 46N107B71O)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorBROWN (OPAQUE BROWN) , WHITE (WHITE) Scoreno score
    ShapeCAPSULE (CAPSULE) Size19mm
    FlavorImprint Code ZA72;80mg
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-610-0630 in 1 BOTTLE; Type 0: Not a Combination Product12/06/2017
    2NDC:65841-610-1460 in 1 BOTTLE; Type 0: Not a Combination Product12/06/2017
    3NDC:65841-610-1690 in 1 BOTTLE; Type 0: Not a Combination Product12/06/2017
    4NDC:65841-610-101000 in 1 BOTTLE; Type 0: Not a Combination Product12/06/2017
    5NDC:65841-610-022000 in 1 BOTTLE; Type 0: Not a Combination Product12/06/2017
    6NDC:65841-610-7710 in 1 CARTON12/06/2017
    6NDC:65841-610-3010 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07901712/06/2017
    ATOMOXETINE 
    atomoxetine capsule
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-611
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ATOMOXETINE HYDROCHLORIDE (UNII: 57WVB6I2W0) (ATOMOXETINE - UNII:ASW034S0B8) ATOMOXETINE100 mg
    Inactive Ingredients
    Ingredient NameStrength
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    GELATIN (UNII: 2G86QN327L)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHELLAC (UNII: 46N107B71O)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    ColorBROWN (OPAQUE BROWN) , BROWN (OPAQUE BROWN) Scoreno score
    ShapeCAPSULE (CAPSULE) Size21mm
    FlavorImprint Code ZA73;100mg
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-611-1460 in 1 BOTTLE; Type 0: Not a Combination Product12/06/2017
    2NDC:65841-611-101000 in 1 BOTTLE; Type 0: Not a Combination Product12/06/2017
    3NDC:65841-611-022000 in 1 BOTTLE; Type 0: Not a Combination Product12/06/2017
    4NDC:65841-611-0630 in 1 BOTTLE; Type 0: Not a Combination Product12/06/2017
    5NDC:65841-611-1690 in 1 BOTTLE; Type 0: Not a Combination Product12/06/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07901712/06/2017
    Labeler - Cadila Healthcare Limited (918596198)
    Registrant - Cadila Healthcare Limited (918596198)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cadila Healthcare Limited918596198ANALYSIS(65841-606, 65841-607, 65841-608, 65841-609, 65841-610, 65841-611) , MANUFACTURE(65841-606, 65841-607, 65841-608, 65841-609, 65841-610, 65841-611)