DOXEPIN HYDROCHLORIDE- doxepin hydrochloride capsule 
Zydus Lifesciences Limited

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Doxepin Hydrochloride Capsules, USP

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1390-7

Doxepin Hydrochloride Capsules USP, 150 mg

Rx only

50 Capsules

150 mg label
DOXEPIN HYDROCHLORIDE 
doxepin hydrochloride capsule
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1390
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOXEPIN HYDROCHLORIDE (UNII: 3U9A0FE9N5) (DOXEPIN - UNII:5ASJ6HUZ7D) DOXEPIN150 mg
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
AMMONIA (UNII: 5138Q19F1X)  
BUTYL ALCOHOL (UNII: 8PJ61P6TS3)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
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 BODY) , BLUE (OPAQUE BLUE CAP) Scoreno score
ShapeCAPSULESize21mm
FlavorImprint Code 1301
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1390-750 in 1 BOTTLE; Type 0: Not a Combination Product03/01/2024
2NDC:70771-1390-1100 in 1 BOTTLE; Type 0: Not a Combination Product03/01/2024
3NDC:70771-1390-5500 in 1 BOTTLE; Type 0: Not a Combination Product03/01/2024
4NDC:70771-1390-410 in 1 CARTON03/01/2024
4NDC:70771-1390-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21014003/01/2024
Labeler - Zydus Lifesciences Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Zydus Lifesciences Limited918596198ANALYSIS(70771-1390) , MANUFACTURE(70771-1390)

Revised: 7/2024
Document Id: 428539cc-fde4-467b-baf4-c23bffd25491
Set id: 725afbaf-7713-4824-b662-ea6cf949295c
Version: 1
Effective Time: 20240703
 
Zydus Lifesciences Limited