Label: TRAZODONE HYDROCHLORIDE tablet

  • NDC Code(s): 70771-1128-0, 70771-1128-1, 70771-1128-2, 70771-1128-3, view more
    70771-1128-4, 70771-1128-5, 70771-1128-9, 70771-1129-0, 70771-1129-1, 70771-1129-2, 70771-1129-3, 70771-1129-4, 70771-1129-5, 70771-1129-9, 70771-1130-0, 70771-1130-1, 70771-1130-2, 70771-1130-3, 70771-1130-4, 70771-1130-5, 70771-1130-9, 70771-1131-0, 70771-1131-1, 70771-1131-2, 70771-1131-3, 70771-1131-4, 70771-1131-5, 70771-1131-9
  • Packager: Cadila Healthcare Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated September 14, 2020

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

  • SPL MEDGUIDE

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC 70771-1128-1

    Trazodone Hydrochloride Tablets USP, 50 mg

    100 Tablets

    Rx only

    Trazodone Hyadrochloride Tablets, USP

    NDC 70771-1129-1

    Trazodone Hydrochloride Tablets USP, 100 mg

    100 Tablets

    Rx only

    Trazodone Hyadrochloride Tablets, USP

    NDC 70771-1130-1

    Trazodone Hydrochloride Tablets USP, 150 mg

    100 Tablets

    Rx only

    Trazodone Hyadrochloride Tablets, USP

    NDC 70771-1131-1

    Trazodone Hydrochloride Tablets USP, 300 mg

    100 Tablets

    Rx only

    Trazodone Hyadrochloride Tablets, USP
  • INGREDIENTS AND APPEARANCE
    TRAZODONE HYDROCHLORIDE 
    trazodone hydrochloride tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1128
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRAZODONE HYDROCHLORIDE (UNII: 6E8ZO8LRNM) (TRAZODONE - UNII:YBK48BXK30) TRAZODONE HYDROCHLORIDE50 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    Product Characteristics
    ColorWHITE (WHITE TO OFF-WHITE) Score2 pieces
    ShapeROUND (ROUND) Size8mm
    FlavorImprint Code 8;05
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1128-990 in 1 BOTTLE; Type 0: Not a Combination Product12/11/2017
    2NDC:70771-1128-1100 in 1 BOTTLE; Type 0: Not a Combination Product12/11/2017
    3NDC:70771-1128-5500 in 1 BOTTLE; Type 0: Not a Combination Product12/11/2017
    4NDC:70771-1128-01000 in 1 BOTTLE; Type 0: Not a Combination Product12/11/2017
    5NDC:70771-1128-410 in 1 CARTON12/11/2017
    5NDC:70771-1128-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
    6NDC:70771-1128-330 in 1 BOTTLE; Type 0: Not a Combination Product12/11/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20525312/11/2017
    TRAZODONE HYDROCHLORIDE 
    trazodone hydrochloride tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1129
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRAZODONE HYDROCHLORIDE (UNII: 6E8ZO8LRNM) (TRAZODONE - UNII:YBK48BXK30) TRAZODONE HYDROCHLORIDE100 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    Product Characteristics
    ColorWHITE (WHITE TO OFF-WHITE) Score2 pieces
    ShapeROUND (ROUND) Size10mm
    FlavorImprint Code 8;06
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1129-330 in 1 BOTTLE; Type 0: Not a Combination Product12/11/2017
    2NDC:70771-1129-990 in 1 BOTTLE; Type 0: Not a Combination Product12/11/2017
    3NDC:70771-1129-1100 in 1 BOTTLE; Type 0: Not a Combination Product12/11/2017
    4NDC:70771-1129-5500 in 1 BOTTLE; Type 0: Not a Combination Product12/11/2017
    5NDC:70771-1129-01000 in 1 BOTTLE; Type 0: Not a Combination Product12/11/2017
    6NDC:70771-1129-410 in 1 CARTON12/11/2017
    6NDC:70771-1129-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20525312/11/2017
    TRAZODONE HYDROCHLORIDE 
    trazodone hydrochloride tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1130
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRAZODONE HYDROCHLORIDE (UNII: 6E8ZO8LRNM) (TRAZODONE - UNII:YBK48BXK30) TRAZODONE HYDROCHLORIDE150 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    Product Characteristics
    ColorWHITE (WHITE TO OFF-WHITE) Score3 pieces
    ShapeOVAL (OVAL) Size17mm
    FlavorImprint Code 8;07
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1130-330 in 1 BOTTLE; Type 0: Not a Combination Product12/11/2017
    2NDC:70771-1130-990 in 1 BOTTLE; Type 0: Not a Combination Product12/11/2017
    3NDC:70771-1130-1100 in 1 BOTTLE; Type 0: Not a Combination Product12/11/2017
    4NDC:70771-1130-5500 in 1 BOTTLE; Type 0: Not a Combination Product12/11/2017
    5NDC:70771-1130-01000 in 1 BOTTLE; Type 0: Not a Combination Product12/11/2017
    6NDC:70771-1130-410 in 1 CARTON12/11/2017
    6NDC:70771-1130-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20525312/11/2017
    TRAZODONE HYDROCHLORIDE 
    trazodone hydrochloride tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1131
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRAZODONE HYDROCHLORIDE (UNII: 6E8ZO8LRNM) (TRAZODONE - UNII:YBK48BXK30) TRAZODONE HYDROCHLORIDE300 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    Product Characteristics
    ColorWHITE (WHITE TO OFF-WHITE) Score3 pieces
    ShapeOVAL (OVAL) Size21mm
    FlavorImprint Code 8;08
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1131-330 in 1 BOTTLE; Type 1: Convenience Kit of Co-Package12/11/2017
    2NDC:70771-1131-990 in 1 BOTTLE; Type 0: Not a Combination Product12/11/2017
    3NDC:70771-1131-1100 in 1 BOTTLE; Type 0: Not a Combination Product12/11/2017
    4NDC:70771-1131-5500 in 1 BOTTLE; Type 0: Not a Combination Product12/11/2017
    5NDC:70771-1131-01000 in 1 BOTTLE; Type 0: Not a Combination Product12/11/2017
    6NDC:70771-1131-410 in 1 CARTON12/11/2017
    6NDC:70771-1131-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20525312/11/2017
    Labeler - Cadila Healthcare Limited (918596198)
    Registrant - Cadila Healthcare Limited (918596198)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cadila Healthcare Limited863362789ANALYSIS(70771-1128, 70771-1129, 70771-1130, 70771-1131) , MANUFACTURE(70771-1128, 70771-1129, 70771-1130, 70771-1131)