Label: VENLAFAXINE HYDROCHLORIDE capsule, extended release

  • NDC Code(s): 70771-1836-0, 70771-1836-2, 70771-1836-3, 70771-1836-4, view more
    70771-1836-5, 70771-1836-9, 70771-1837-0, 70771-1837-2, 70771-1837-3, 70771-1837-4, 70771-1837-5, 70771-1837-9, 70771-1838-0, 70771-1838-2, 70771-1838-3, 70771-1838-4, 70771-1838-5, 70771-1838-9
  • Packager: Zydus Lifesciences Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated May 19, 2023

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  • SPL UNCLASSIFIED SECTION

  • MEDICATION GUIDE

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC 70771-1836-9

    Venlafaxine Hydrochloride Extended-release Capsules USP, 37.5 mg

    90 Capsules

    Rx only

    37.5 mg label

    NDC 70771-1837-9

    Venlafaxine Hydrochloride Extended-release Capsules USP, 75 mg

    90 Capsules

    Rx only

    75 mg label

    NDC 70771-1838-9

    Venlafaxine Hydrochloride Extended-release Capsules USP, 150 mg

    90 Capsules

    Rx only

    150 mg label
  • INGREDIENTS AND APPEARANCE
    VENLAFAXINE HYDROCHLORIDE 
    venlafaxine hydrochloride capsule, extended release
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1836
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    VENLAFAXINE HYDROCHLORIDE (UNII: 7D7RX5A8MO) (VENLAFAXINE - UNII:GRZ5RCB1QG) VENLAFAXINE37.5 mg
    Inactive Ingredients
    Ingredient NameStrength
    ETHYLCELLULOSE (7 MPA.S) (UNII: H3UP11403C)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    GELATIN (UNII: 2G86QN327L)  
    HYPROMELLOSE 2910 (15 MPA.S) (UNII: 36SFW2JZ0W)  
    HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL 8000 (UNII: Q662QK8M3B)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHELLAC (UNII: 46N107B71O)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorGRAY (grey opaque colored cap) , WHITE (white opaque colored body) Scoreno score
    ShapeCAPSULESize16mm
    FlavorImprint Code ZA;35;37;5;mg
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1836-990 in 1 BOTTLE; Type 0: Not a Combination Product05/18/2023
    2NDC:70771-1836-01000 in 1 BOTTLE; Type 0: Not a Combination Product05/18/2023
    3NDC:70771-1836-410 in 1 CARTON05/18/2023
    3NDC:70771-1836-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
    4NDC:70771-1836-330 in 1 BOTTLE; Type 0: Not a Combination Product05/18/2023
    5NDC:70771-1836-5500 in 1 BOTTLE; Type 0: Not a Combination Product05/18/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09017405/18/2023
    VENLAFAXINE HYDROCHLORIDE 
    venlafaxine hydrochloride capsule, extended release
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1837
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    VENLAFAXINE HYDROCHLORIDE (UNII: 7D7RX5A8MO) (VENLAFAXINE - UNII:GRZ5RCB1QG) VENLAFAXINE75 mg
    Inactive Ingredients
    Ingredient NameStrength
    ETHYLCELLULOSE (7 MPA.S) (UNII: H3UP11403C)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    GELATIN (UNII: 2G86QN327L)  
    HYPROMELLOSE 2910 (15 MPA.S) (UNII: 36SFW2JZ0W)  
    HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL 8000 (UNII: Q662QK8M3B)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHELLAC (UNII: 46N107B71O)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorPINK (peach opaque colored cap) , WHITE (white opaque colored body) Scoreno score
    ShapeCAPSULESize19mm
    FlavorImprint Code ZA;36;75;mg
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1837-5500 in 1 BOTTLE; Type 0: Not a Combination Product05/18/2023
    2NDC:70771-1837-01000 in 1 BOTTLE; Type 0: Not a Combination Product05/18/2023
    3NDC:70771-1837-410 in 1 CARTON05/18/2023
    3NDC:70771-1837-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
    4NDC:70771-1837-330 in 1 BOTTLE; Type 0: Not a Combination Product05/18/2023
    5NDC:70771-1837-990 in 1 BOTTLE; Type 0: Not a Combination Product05/18/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09017405/18/2023
    VENLAFAXINE HYDROCHLORIDE 
    venlafaxine hydrochloride capsule, extended release
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1838
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    VENLAFAXINE HYDROCHLORIDE (UNII: 7D7RX5A8MO) (VENLAFAXINE - UNII:GRZ5RCB1QG) VENLAFAXINE150 mg
    Inactive Ingredients
    Ingredient NameStrength
    ETHYLCELLULOSE (7 MPA.S) (UNII: H3UP11403C)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    GELATIN (UNII: 2G86QN327L)  
    HYPROMELLOSE 2910 (15 MPA.S) (UNII: 36SFW2JZ0W)  
    HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL 8000 (UNII: Q662QK8M3B)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHELLAC (UNII: 46N107B71O)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorORANGE (dark orange opaque colored cap) , WHITE (white opaque colored body) Scoreno score
    ShapeCAPSULESize23mm
    FlavorImprint Code ZA;37;150;mg
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1838-330 in 1 BOTTLE; Type 0: Not a Combination Product05/18/2023
    2NDC:70771-1838-990 in 1 BOTTLE; Type 0: Not a Combination Product05/18/2023
    3NDC:70771-1838-5500 in 1 BOTTLE; Type 0: Not a Combination Product05/18/2023
    4NDC:70771-1838-01000 in 1 BOTTLE; Type 0: Not a Combination Product05/18/2023
    5NDC:70771-1838-410 in 1 CARTON05/18/2023
    5NDC:70771-1838-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09017405/18/2023
    Labeler - Zydus Lifesciences Limited (918596198)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zydus Lifesciences Limited918596198ANALYSIS(70771-1836, 70771-1837, 70771-1838) , MANUFACTURE(70771-1836, 70771-1837, 70771-1838)
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