DOXEPIN- doxepin tablet 
Zydus Lifesciences Limited

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DOXEPIN tablets, for oral use

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1528-5 in bottle of 500 tablets

Doxepin Tablets, 3 mg

Rx only

500 tablets

3 mg label

NDC 70771-1529-5 in bottle of 500 tablets

Doxepin Tablets, 6 mg

Rx only

500 tablets

6 mg label
DOXEPIN 
doxepin tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1528
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOXEPIN HYDROCHLORIDE (UNII: 3U9A0FE9N5) (DOXEPIN - UNII:5ASJ6HUZ7D) DOXEPIN3 mg
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
STARCH, CORN (UNII: O8232NY3SJ)  
TALC (UNII: 7SEV7J4R1U)  
Product Characteristics
ColorBLUE (LIGHT BLUE) Scoreno score
ShapeROUND (ROUND) Size6mm
FlavorImprint Code 393
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1528-330 in 1 BOTTLE; Type 0: Not a Combination Product08/25/2023
2NDC:70771-1528-990 in 1 BOTTLE; Type 0: Not a Combination Product08/25/2023
3NDC:70771-1528-1100 in 1 BOTTLE; Type 0: Not a Combination Product08/25/2023
4NDC:70771-1528-5500 in 1 BOTTLE; Type 0: Not a Combination Product08/25/2023
5NDC:70771-1528-01000 in 1 BOTTLE; Type 0: Not a Combination Product08/25/2023
6NDC:70771-1528-410 in 1 CARTON08/25/2023
610 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20276108/25/2023
DOXEPIN 
doxepin tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1529
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOXEPIN HYDROCHLORIDE (UNII: 3U9A0FE9N5) (DOXEPIN - UNII:5ASJ6HUZ7D) DOXEPIN6 mg
Inactive Ingredients
Ingredient NameStrength
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
TALC (UNII: 7SEV7J4R1U)  
STARCH, CORN (UNII: O8232NY3SJ)  
Product Characteristics
ColorGREEN (LIGHT GREEN) Scoreno score
ShapeROUND (ROUND) Size6mm
FlavorImprint Code 394
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1529-330 in 1 BOTTLE; Type 0: Not a Combination Product08/25/2023
2NDC:70771-1529-990 in 1 BOTTLE; Type 0: Not a Combination Product08/25/2023
3NDC:70771-1529-1100 in 1 BOTTLE; Type 0: Not a Combination Product08/25/2023
4NDC:70771-1529-5500 in 1 BOTTLE; Type 0: Not a Combination Product08/25/2023
5NDC:70771-1529-01000 in 1 BOTTLE; Type 0: Not a Combination Product08/25/2023
6NDC:70771-1529-410 in 1 CARTON08/25/2023
610 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20276108/25/2023
Labeler - Zydus Lifesciences Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Zydus Lifesciences Limited863362789ANALYSIS(70771-1528, 70771-1529) , MANUFACTURE(70771-1528, 70771-1529)

Revised: 9/2023
Document Id: 7527369f-667a-4706-b7ac-6ea6bc643e88
Set id: 1461ede6-24f0-42a1-b801-0cf4ef404985
Version: 1
Effective Time: 20230918
 
Zydus Lifesciences Limited