DOXEPIN HYDROCHLORIDE- doxepin hydrochloride capsule 
Zydus Lifesciences Limited

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DOXEPIN HYDROCHLORIDE CAPSULES, USP

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
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)

Revised: 7/2024
Document Id: d4ac01e6-a2e5-419b-9fea-6948855dcce2
Set id: e9764518-d9e8-4e43-acf7-a7070a33a6c0
Version: 1
Effective Time: 20240703
 
Zydus Lifesciences Limited