Label: DOXEPIN tablet

  • NDC Code(s): 70771-1528-0, 70771-1528-1, 70771-1528-3, 70771-1528-4, view more
    70771-1528-5, 70771-1528-9, 70771-1529-0, 70771-1529-1, 70771-1529-3, 70771-1529-4, 70771-1529-5, 70771-1529-9
  • Packager: Zydus Lifesciences Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated June 12, 2024

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

  • SPL UNCLASSIFIED SECTION

  • MEDICATION GUIDE

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC 70771-1528-3 in bottle of 30 tablets

    Doxepin Tablets, 3 mg

    Rx only

    30 tablets

    3 mg label

    NDC 70771-1529-3 in bottle of 30 tablets

    Doxepin Tablets, 6 mg

    Rx only

    30 tablets

    6 mg label
  • INGREDIENTS AND APPEARANCE
    DOXEPIN 
    doxepin tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1528
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DOXEPIN HYDROCHLORIDE (UNII: 3U9A0FE9N5) (DOXEPIN - UNII:5ASJ6HUZ7D) DOXEPIN3 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    TALC (UNII: 7SEV7J4R1U)  
    Product Characteristics
    ColorBLUE (LIGHT BLUE) Scoreno score
    ShapeROUND (ROUND) Size6mm
    FlavorImprint Code 393
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1528-330 in 1 BOTTLE; Type 0: Not a Combination Product06/30/2024
    2NDC:70771-1528-990 in 1 BOTTLE; Type 0: Not a Combination Product06/30/2024
    3NDC:70771-1528-1100 in 1 BOTTLE; Type 0: Not a Combination Product06/30/2024
    4NDC:70771-1528-5500 in 1 BOTTLE; Type 0: Not a Combination Product06/30/2024
    5NDC:70771-1528-01000 in 1 BOTTLE; Type 0: Not a Combination Product06/30/2024
    6NDC:70771-1528-410 in 1 CARTON06/30/2024
    610 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20276106/30/2024
    DOXEPIN 
    doxepin tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1529
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DOXEPIN HYDROCHLORIDE (UNII: 3U9A0FE9N5) (DOXEPIN - UNII:5ASJ6HUZ7D) DOXEPIN6 mg
    Inactive Ingredients
    Ingredient NameStrength
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    TALC (UNII: 7SEV7J4R1U)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    ColorGREEN (LIGHT GREEN) Scoreno score
    ShapeROUND (ROUND) Size6mm
    FlavorImprint Code 394
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1529-330 in 1 BOTTLE; Type 0: Not a Combination Product06/30/2024
    2NDC:70771-1529-990 in 1 BOTTLE; Type 0: Not a Combination Product06/30/2024
    3NDC:70771-1529-1100 in 1 BOTTLE; Type 0: Not a Combination Product06/30/2024
    4NDC:70771-1529-5500 in 1 BOTTLE; Type 0: Not a Combination Product06/30/2024
    5NDC:70771-1529-01000 in 1 BOTTLE; Type 0: Not a Combination Product06/30/2024
    6NDC:70771-1529-410 in 1 CARTON06/30/2024
    610 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20276106/30/2024
    Labeler - Zydus Lifesciences Limited (918596198)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zydus Lifesciences Limited863362789ANALYSIS(70771-1528, 70771-1529) , MANUFACTURE(70771-1528, 70771-1529)