Label: AMITRIPTYLINE HYDROCHLORIDE tablet, film coated

  • NDC Code(s): 70771-1173-0, 70771-1173-1, 70771-1174-0, 70771-1174-1, view more
    70771-1175-0, 70771-1175-1, 70771-1176-0, 70771-1176-1, 70771-1177-0, 70771-1177-1, 70771-1178-0, 70771-1178-1
  • Packager: Cadila Healthcare Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated August 13, 2020

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

  • SPL UNCLASSIFIED SECTION

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC 70771-1173-1 in bottle of 100 Tablets

    Amitriptyline Hydrochloride Tablets USP, 10 mg

    Rx only

    100 Tablets

    Amitriptyline Hydrochloride Tablets, USP

    NDC 70771-1174-1 in bottle of 100 Tablets

    Amitriptyline Hydrochloride Tablets USP, 25 mg

    Rx only

    100 Tablets

    Amitriptyline Hydrochloride Tablets, USP

    NDC 70771-1175-1 in bottle of 100 Tablets

    Amitriptyline Hydrochloride Tablets USP, 50 mg

    Rx only

    100 Tablets

    Amitriptyline Hydrochloride Tablets, USP

    NDC 70771-1176-1 in bottle of 100 Tablets

    Amitriptyline Hydrochloride Tablets USP, 75 mg

    Rx only

    100 Tablets

    Amitriptyline Hydrochloride Tablets, USP

    NDC 70771-1177-1 in bottle of 100 Tablets

    Amitriptyline Hydrochloride Tablets USP, 100 mg

    Rx only

    100 Tablets

    Amitriptyline Hydrochloride Tablets, USP

    NDC 70771-1178-1 in bottle of 100 Tablets

    Amitriptyline Hydrochloride Tablets USP, 150 mg

    Rx only

    100 Tablets

    Amitriptyline Hydrochloride Tablets, USP
  • INGREDIENTS AND APPEARANCE
    AMITRIPTYLINE HYDROCHLORIDE 
    amitriptyline hydrochloride tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1173
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AMITRIPTYLINE HYDROCHLORIDE (UNII: 26LUD4JO9K) (AMITRIPTYLINE - UNII:1806D8D52K) AMITRIPTYLINE HYDROCHLORIDE10 mg
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)  
    POLYETHYLENE GLYCOL 8000 (UNII: Q662QK8M3B)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TALC (UNII: 7SEV7J4R1U)  
    Product Characteristics
    ColorWHITE (OFF-WHITE) Scoreno score
    ShapeROUND (ROUND) Size5mm
    FlavorImprint Code ZA;1
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1173-1100 in 1 BOTTLE; Type 0: Not a Combination Product12/26/2017
    2NDC:70771-1173-01000 in 1 BOTTLE; Type 0: Not a Combination Product12/26/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21008612/26/2017
    AMITRIPTYLINE HYDROCHLORIDE 
    amitriptyline hydrochloride tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1174
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AMITRIPTYLINE HYDROCHLORIDE (UNII: 26LUD4JO9K) (AMITRIPTYLINE - UNII:1806D8D52K) AMITRIPTYLINE HYDROCHLORIDE25 mg
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)  
    POLYETHYLENE GLYCOL 8000 (UNII: Q662QK8M3B)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    Product Characteristics
    ColorGREEN (LIGHT GREEN) Scoreno score
    ShapeROUND (ROUND) Size6mm
    FlavorImprint Code ZA;2
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1174-1100 in 1 BOTTLE; Type 0: Not a Combination Product12/26/2017
    2NDC:70771-1174-01000 in 1 BOTTLE; Type 0: Not a Combination Product12/26/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21008612/26/2017
    AMITRIPTYLINE HYDROCHLORIDE 
    amitriptyline hydrochloride tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1175
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AMITRIPTYLINE HYDROCHLORIDE (UNII: 26LUD4JO9K) (AMITRIPTYLINE - UNII:1806D8D52K) AMITRIPTYLINE HYDROCHLORIDE50 mg
    Inactive Ingredients
    Ingredient NameStrength
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOL 8000 (UNII: Q662QK8M3B)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorBROWN (BROWN) Scoreno score
    ShapeROUND (ROUND) Size8mm
    FlavorImprint Code ZA;3
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1175-1100 in 1 BOTTLE; Type 0: Not a Combination Product12/26/2017
    2NDC:70771-1175-01000 in 1 BOTTLE; Type 0: Not a Combination Product12/26/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21008612/26/2017
    AMITRIPTYLINE HYDROCHLORIDE 
    amitriptyline hydrochloride tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1176
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AMITRIPTYLINE HYDROCHLORIDE (UNII: 26LUD4JO9K) (AMITRIPTYLINE - UNII:1806D8D52K) AMITRIPTYLINE HYDROCHLORIDE75 mg
    Inactive Ingredients
    Ingredient NameStrength
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOL 8000 (UNII: Q662QK8M3B)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorBLUE (LIGHT BLUE) Scoreno score
    ShapeROUND (ROUND) Size11mm
    FlavorImprint Code 12;28
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1176-1100 in 1 BOTTLE; Type 0: Not a Combination Product12/26/2017
    2NDC:70771-1176-01000 in 1 BOTTLE; Type 0: Not a Combination Product12/26/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21008612/26/2017
    AMITRIPTYLINE HYDROCHLORIDE 
    amitriptyline hydrochloride tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1177
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AMITRIPTYLINE HYDROCHLORIDE (UNII: 26LUD4JO9K) (AMITRIPTYLINE - UNII:1806D8D52K) AMITRIPTYLINE HYDROCHLORIDE100 mg
    Inactive Ingredients
    Ingredient NameStrength
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOL 8000 (UNII: Q662QK8M3B)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorORANGE (ORANGE) Scoreno score
    ShapeROUND (ROUND) Size11mm
    FlavorImprint Code 12;29
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1177-1100 in 1 BOTTLE; Type 0: Not a Combination Product12/26/2017
    2NDC:70771-1177-01000 in 1 BOTTLE; Type 0: Not a Combination Product12/26/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21008612/26/2017
    AMITRIPTYLINE HYDROCHLORIDE 
    amitriptyline hydrochloride tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1178
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AMITRIPTYLINE HYDROCHLORIDE (UNII: 26LUD4JO9K) (AMITRIPTYLINE - UNII:1806D8D52K) AMITRIPTYLINE HYDROCHLORIDE150 mg
    Inactive Ingredients
    Ingredient NameStrength
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOL 8000 (UNII: Q662QK8M3B)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorWHITE (CREAM TO BEIGE) Scoreno score
    ShapeCAPSULE (MODIFIED CAPSULE) Size17mm
    FlavorImprint Code 1230
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1178-1100 in 1 BOTTLE; Type 0: Not a Combination Product12/26/2017
    2NDC:70771-1178-01000 in 1 BOTTLE; Type 0: Not a Combination Product12/26/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21008612/26/2017
    Labeler - Cadila Healthcare Limited (918596198)
    Registrant - Cadila Healthcare Limited (918596198)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cadila Healthcare Limited863362789ANALYSIS(70771-1173, 70771-1174, 70771-1175, 70771-1176, 70771-1177, 70771-1178) , MANUFACTURE(70771-1173, 70771-1174, 70771-1175, 70771-1176, 70771-1177, 70771-1178)