Label: DOXEPIN HYDROCHLORIDE capsule

  • NDC Code(s): 70771-1385-0, 70771-1385-1, 70771-1385-2, 70771-1385-4, view more
    70771-1386-0, 70771-1386-1, 70771-1386-2, 70771-1386-4, 70771-1387-0, 70771-1387-1, 70771-1387-2, 70771-1387-4, 70771-1388-0, 70771-1388-1, 70771-1388-2, 70771-1388-4, 70771-1389-0, 70771-1389-1, 70771-1389-2, 70771-1389-4
  • Packager: Zydus Lifesciences Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated July 3, 2024

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

  • SPL UNCLASSIFIED SECTION

  • MEDICATION GUIDE

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC 70771-1385-1

    Doxepin Hydrochloride Capsules USP, 10 mg

    Rx only

    100 Capsules

    10 mg

    NDC 70771-1386-1

    Doxepin Hydrochloride Capsules USP, 25 mg

    Rx only

    100 Capsules

    25 mg

    NDC 70771-1387-1

    Doxepin Hydrochloride Capsules USP, 50 mg

    Rx only

    100 Capsules

    50 mg

    NDC 70771-1388-1

    Doxepin Hydrochloride Capsules USP, 75 mg

    Rx only

    100 Capsules

    75 mg

    NDC 70771-1389-1

    Doxepin Hydrochloride Capsules USP, 100 mg

    Rx only

    100 Capsules

    100 mg
  • INGREDIENTS AND APPEARANCE
    DOXEPIN HYDROCHLORIDE 
    doxepin hydrochloride capsule
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1385
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DOXEPIN HYDROCHLORIDE (UNII: 3U9A0FE9N5) (DOXEPIN - UNII:5ASJ6HUZ7D) DOXEPIN10 mg
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    AMMONIA (UNII: 5138Q19F1X)  
    BUTYL ALCOHOL (UNII: 8PJ61P6TS3)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    GELATIN (UNII: 2G86QN327L)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHELLAC (UNII: 46N107B71O)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorWHITE (opaque white cap) , WHITE (opaque white body) Scoreno score
    ShapeCAPSULESize14mm
    FlavorImprint Code 1296
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1385-1100 in 1 BOTTLE; Type 0: Not a Combination Product03/01/2024
    2NDC:70771-1385-01000 in 1 BOTTLE; Type 0: Not a Combination Product03/01/2024
    3NDC:70771-1385-410 in 1 CARTON03/01/2024
    3NDC:70771-1385-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21070003/01/2024
    DOXEPIN HYDROCHLORIDE 
    doxepin hydrochloride capsule
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1386
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DOXEPIN HYDROCHLORIDE (UNII: 3U9A0FE9N5) (DOXEPIN - UNII:5ASJ6HUZ7D) DOXEPIN25 mg
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    AMMONIA (UNII: 5138Q19F1X)  
    BUTYL ALCOHOL (UNII: 8PJ61P6TS3)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    GELATIN (UNII: 2G86QN327L)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHELLAC (UNII: 46N107B71O)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorYELLOW (opaque yellow cap) , WHITE (opaque white body) Scoreno score
    ShapeCAPSULESize16mm
    FlavorImprint Code 1297
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1386-1100 in 1 BOTTLE; Type 0: Not a Combination Product03/01/2024
    2NDC:70771-1386-410 in 1 CARTON03/01/2024
    2NDC:70771-1386-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3NDC:70771-1386-01000 in 1 BOTTLE; Type 0: Not a Combination Product03/01/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21070003/01/2024
    DOXEPIN HYDROCHLORIDE 
    doxepin hydrochloride capsule
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1387
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DOXEPIN HYDROCHLORIDE (UNII: 3U9A0FE9N5) (DOXEPIN - UNII:5ASJ6HUZ7D) DOXEPIN50 mg
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    AMMONIA (UNII: 5138Q19F1X)  
    BUTYL ALCOHOL (UNII: 8PJ61P6TS3)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    GELATIN (UNII: 2G86QN327L)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHELLAC (UNII: 46N107B71O)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorYELLOW (opaque yellow cap) , YELLOW (opaque yellow body) Scoreno score
    ShapeCAPSULESize18mm
    FlavorImprint Code 1298
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1387-1100 in 1 BOTTLE; Type 0: Not a Combination Product03/01/2024
    2NDC:70771-1387-01000 in 1 BOTTLE; Type 0: Not a Combination Product03/01/2024
    3NDC:70771-1387-410 in 1 CARTON03/01/2024
    3NDC:70771-1387-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21070003/01/2024
    DOXEPIN HYDROCHLORIDE 
    doxepin hydrochloride capsule
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1388
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DOXEPIN HYDROCHLORIDE (UNII: 3U9A0FE9N5) (DOXEPIN - UNII:5ASJ6HUZ7D) DOXEPIN75 mg
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    AMMONIA (UNII: 5138Q19F1X)  
    BUTYL ALCOHOL (UNII: 8PJ61P6TS3)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    GELATIN (UNII: 2G86QN327L)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHELLAC (UNII: 46N107B71O)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorGREEN (opaque green cap) , GREEN (opaque green body) Scoreno score
    ShapeCAPSULESize18mm
    FlavorImprint Code 1299
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1388-1100 in 1 BOTTLE; Type 0: Not a Combination Product03/01/2024
    2NDC:70771-1388-01000 in 1 BOTTLE; Type 0: Not a Combination Product03/01/2024
    3NDC:70771-1388-410 in 1 CARTON03/01/2024
    3NDC:70771-1388-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21070003/01/2024
    DOXEPIN HYDROCHLORIDE 
    doxepin hydrochloride capsule
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1389
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DOXEPIN HYDROCHLORIDE (UNII: 3U9A0FE9N5) (DOXEPIN - UNII:5ASJ6HUZ7D) DOXEPIN100 mg
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    AMMONIA (UNII: 5138Q19F1X)  
    BUTYL ALCOHOL (UNII: 8PJ61P6TS3)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    GELATIN (UNII: 2G86QN327L)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHELLAC (UNII: 46N107B71O)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorGREEN (opaque green cap) , WHITE (opaque white body) Scoreno score
    ShapeCAPSULESize19mm
    FlavorImprint Code 1300
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1389-1100 in 1 BOTTLE; Type 0: Not a Combination Product03/01/2024
    2NDC:70771-1389-01000 in 1 BOTTLE; Type 0: Not a Combination Product03/01/2024
    3NDC:70771-1389-410 in 1 CARTON03/01/2024
    3NDC:70771-1389-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21070003/01/2024
    Labeler - Zydus Lifesciences Limited (918596198)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zydus Lifesciences Limited918596198ANALYSIS(70771-1385, 70771-1386, 70771-1387, 70771-1388, 70771-1389) , MANUFACTURE(70771-1385, 70771-1386, 70771-1387, 70771-1388, 70771-1389)