Label: DULOXETINE capsule, delayed release

  • NDC Code(s): 65841-799-06, 65841-799-14, 65841-799-16, 65841-800-06, view more
    65841-800-10, 65841-800-16, 65841-801-06, 65841-801-10, 65841-801-16
  • Packager: Cadila Healthcare Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated August 21, 2020

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

  • MEDICATION GUIDE

    Manufactured by:

    Cadila Healthcare Ltd.

    India

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC 65841-799-16

    Duloxetine Delayed-release Capsules, 20mg

    90 Capsules

    Rx only

    Duloxetine delayed-release capsules

    NDC 65841-800-16

    Duloxetine Delayed-release Capsules, 30mg

    90 Capsules

    Rx only

    Duloxetine delayed-release capsules

    NDC 65841-801-16

    Duloxetine Delayed-release Capsules, 60mg

    90 Capsules

    Rx only

    Duloxetine delayed-release capsules
  • INGREDIENTS AND APPEARANCE
    DULOXETINE 
    duloxetine capsule, delayed release
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-799
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DULOXETINE HYDROCHLORIDE (UNII: 9044SC542W) (DULOXETINE - UNII:O5TNM5N07U) DULOXETINE20 mg
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    AMMONIA (UNII: 5138Q19F1X)  
    BUTYL ALCOHOL (UNII: 8PJ61P6TS3)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    GELATIN (UNII: 2G86QN327L)  
    HYPROMELLOSE PHTHALATE (31% PHTHALATE, 40 CST) (UNII: G4U024CQK6)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHELLAC (UNII: 46N107B71O)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SUCROSE (UNII: C151H8M554)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    Product Characteristics
    ColorGREEN (GREEN) , WHITE (WHITE) Scoreno score
    ShapeCAPSULE (CAPSULE) Size14mm
    FlavorImprint Code 241;20;mg
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-799-0630 in 1 BOTTLE; Type 0: Not a Combination Product05/27/2014
    2NDC:65841-799-1460 in 1 BOTTLE; Type 0: Not a Combination Product05/27/2014
    3NDC:65841-799-1690 in 1 BOTTLE; Type 0: Not a Combination Product05/27/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09073905/27/2014
    DULOXETINE 
    duloxetine capsule, delayed release
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-800
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DULOXETINE HYDROCHLORIDE (UNII: 9044SC542W) (DULOXETINE - UNII:O5TNM5N07U) DULOXETINE30 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    GELATIN (UNII: 2G86QN327L)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    HYPROMELLOSE PHTHALATE (31% PHTHALATE, 40 CST) (UNII: G4U024CQK6)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SUCROSE (UNII: C151H8M554)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    BUTYL ALCOHOL (UNII: 8PJ61P6TS3)  
    ALCOHOL (UNII: 3K9958V90M)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHELLAC (UNII: 46N107B71O)  
    AMMONIA (UNII: 5138Q19F1X)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    ColorBLUE (BLUE) , GREEN (GREEN) Scoreno score
    ShapeCAPSULE (CAPSULE) Size16mm
    FlavorImprint Code 242;30;mg
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-800-0630 in 1 BOTTLE; Type 0: Not a Combination Product05/27/2014
    2NDC:65841-800-1690 in 1 BOTTLE; Type 0: Not a Combination Product05/27/2014
    3NDC:65841-800-101000 in 1 BOTTLE; Type 0: Not a Combination Product05/27/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09073905/27/2014
    DULOXETINE 
    duloxetine capsule, delayed release
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-801
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DULOXETINE HYDROCHLORIDE (UNII: 9044SC542W) (DULOXETINE - UNII:O5TNM5N07U) DULOXETINE60 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    GELATIN (UNII: 2G86QN327L)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    HYPROMELLOSE PHTHALATE (31% PHTHALATE, 40 CST) (UNII: G4U024CQK6)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SUCROSE (UNII: C151H8M554)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    BUTYL ALCOHOL (UNII: 8PJ61P6TS3)  
    ALCOHOL (UNII: 3K9958V90M)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHELLAC (UNII: 46N107B71O)  
    AMMONIA (UNII: 5138Q19F1X)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    ColorBLUE (BLUE) , WHITE (WHITE) Scoreno score
    ShapeCAPSULE (CAPSULE) Size19mm
    FlavorImprint Code 243;60;mg
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-801-0630 in 1 BOTTLE; Type 0: Not a Combination Product05/27/2014
    2NDC:65841-801-1690 in 1 BOTTLE; Type 0: Not a Combination Product05/27/2014
    3NDC:65841-801-101000 in 1 BOTTLE; Type 0: Not a Combination Product05/27/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09073905/27/2014
    Labeler - Cadila Healthcare Limited (918596198)
    Registrant - Cadila Healthcare Limited (918596198)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cadila Healthcare Limited918596198ANALYSIS(65841-799, 65841-800, 65841-801) , MANUFACTURE(65841-799, 65841-800, 65841-801)