DULOXETINE- duloxetine capsule, delayed release 
Zydus Lifesciences Limited

----------

DULOXETINE DELAYED-RELEASE CAPSULES

Manufactured by:

Cadila Healthcare Ltd.

India.

SPL MEDGUIDE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1344-3

Duloxetine Delayed-release Capsules, 20mg

30 Capsules

Rx only

Duloxetine delayed-release capsules

NDC 70771-1345-3

Duloxetine Delayed-release Capsules, 30mg

30 Capsules

Rx only

Duloxetine delayed-release capsules

NDC 70771-1346-3

Duloxetine Delayed-release Capsules, 60mg

30 Capsules

Rx only

Duloxetine delayed-release capsules
DULOXETINE 
duloxetine capsule, delayed release
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1344
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DULOXETINE HYDROCHLORIDE (UNII: 9044SC542W) (DULOXETINE - UNII:O5TNM5N07U) DULOXETINE20 mg
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
AMMONIA (UNII: 5138Q19F1X)  
BUTYL ALCOHOL (UNII: 8PJ61P6TS3)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
GELATIN (UNII: 2G86QN327L)  
HYPROMELLOSE PHTHALATE (31% PHTHALATE, 40 CST) (UNII: G4U024CQK6)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SHELLAC (UNII: 46N107B71O)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
STARCH, CORN (UNII: O8232NY3SJ)  
SUCROSE (UNII: C151H8M554)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
Product Characteristics
ColorGREEN (GREEN) , WHITE (WHITE) Scoreno score
ShapeCAPSULE (CAPSULE) Size14mm
FlavorImprint Code 385;20;mg
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1344-330 in 1 BOTTLE; Type 0: Not a Combination Product05/27/2014
2NDC:70771-1344-660 in 1 BOTTLE; Type 0: Not a Combination Product05/27/2014
3NDC:70771-1344-990 in 1 BOTTLE; Type 0: Not a Combination Product05/27/2014
4NDC:70771-1344-01000 in 1 BOTTLE; Type 0: Not a Combination Product04/06/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09072805/27/2014
DULOXETINE 
duloxetine capsule, delayed release
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1345
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DULOXETINE HYDROCHLORIDE (UNII: 9044SC542W) (DULOXETINE - UNII:O5TNM5N07U) DULOXETINE30 mg
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
GELATIN (UNII: 2G86QN327L)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
HYPROMELLOSE PHTHALATE (31% PHTHALATE, 40 CST) (UNII: G4U024CQK6)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
SUCROSE (UNII: C151H8M554)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
BUTYL ALCOHOL (UNII: 8PJ61P6TS3)  
ALCOHOL (UNII: 3K9958V90M)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SHELLAC (UNII: 46N107B71O)  
AMMONIA (UNII: 5138Q19F1X)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
STARCH, CORN (UNII: O8232NY3SJ)  
Product Characteristics
ColorBLUE (BLUE) , GREEN (GREEN) Scoreno score
ShapeCAPSULE (CAPSULE) Size16mm
FlavorImprint Code 386;30;mg
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1345-330 in 1 BOTTLE; Type 0: Not a Combination Product05/27/2014
2NDC:70771-1345-990 in 1 BOTTLE; Type 0: Not a Combination Product05/27/2014
3NDC:70771-1345-01000 in 1 BOTTLE; Type 0: Not a Combination Product04/06/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09072805/27/2014
DULOXETINE 
duloxetine capsule, delayed release
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1346
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DULOXETINE HYDROCHLORIDE (UNII: 9044SC542W) (DULOXETINE - UNII:O5TNM5N07U) DULOXETINE60 mg
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
GELATIN (UNII: 2G86QN327L)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
HYPROMELLOSE PHTHALATE (31% PHTHALATE, 40 CST) (UNII: G4U024CQK6)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
SUCROSE (UNII: C151H8M554)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
BUTYL ALCOHOL (UNII: 8PJ61P6TS3)  
ALCOHOL (UNII: 3K9958V90M)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SHELLAC (UNII: 46N107B71O)  
AMMONIA (UNII: 5138Q19F1X)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
STARCH, CORN (UNII: O8232NY3SJ)  
Product Characteristics
ColorBLUE (BLUE) , WHITE (WHITE) Scoreno score
ShapeCAPSULE (CAPSULE) Size19mm
FlavorImprint Code 387;60;mg
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1346-330 in 1 BOTTLE; Type 0: Not a Combination Product05/27/2014
2NDC:70771-1346-990 in 1 BOTTLE; Type 0: Not a Combination Product05/27/2014
3NDC:70771-1346-01000 in 1 BOTTLE; Type 0: Not a Combination Product04/06/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09072805/27/2014
Labeler - Zydus Lifesciences Limited (918596198)
Registrant - Zydus Lifesciences Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Zydus Lifesciences Limited918596198ANALYSIS(70771-1344, 70771-1345, 70771-1346) , MANUFACTURE(70771-1344, 70771-1345, 70771-1346)

Revised: 9/2023
Document Id: 49e233c8-958a-4352-b1df-fbddbbb48a18
Set id: 41f83de2-1aef-47a1-a65c-99cebee9b1b5
Version: 5
Effective Time: 20230921
 
Zydus Lifesciences Limited