DULOXETINE - duloxetine capsule, delayed release 
Zydus Lifesciences Limited

----------

DULOXETINE DELAYED-RELEASE CAPSULES

Manufactured by:

Cadila Healthcare Ltd.

India

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 65841-799-16

Duloxetine Delayed-release Capsules, 20mg

90 Capsules

Rx only

Duloxetine delayed-release capsules

NDC 65841-800-16

Duloxetine Delayed-release Capsules, 30mg

90 Capsules

Rx only

Duloxetine delayed-release capsules

NDC 65841-801-16

Duloxetine Delayed-release Capsules, 60mg

90 Capsules

Rx only

Duloxetine delayed-release capsules
DULOXETINE 
duloxetine capsule, delayed release
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-799
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 241;20;mg
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65841-799-0630 in 1 BOTTLE; Type 0: Not a Combination Product05/27/2014
2NDC:65841-799-1460 in 1 BOTTLE; Type 0: Not a Combination Product05/27/2014
3NDC:65841-799-1690 in 1 BOTTLE; Type 0: Not a Combination Product05/27/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09073905/27/2014
DULOXETINE 
duloxetine capsule, delayed release
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-800
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 242;30;mg
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65841-800-0630 in 1 BOTTLE; Type 0: Not a Combination Product05/27/2014
2NDC:65841-800-1690 in 1 BOTTLE; Type 0: Not a Combination Product05/27/2014
3NDC:65841-800-101000 in 1 BOTTLE; Type 0: Not a Combination Product05/27/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09073905/27/2014
DULOXETINE 
duloxetine capsule, delayed release
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-801
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 243;60;mg
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65841-801-0630 in 1 BOTTLE; Type 0: Not a Combination Product05/27/2014
2NDC:65841-801-1690 in 1 BOTTLE; Type 0: Not a Combination Product05/27/2014
3NDC:65841-801-101000 in 1 BOTTLE; Type 0: Not a Combination Product05/27/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09073905/27/2014
Labeler - Zydus Lifesciences Limited (918596198)
Registrant - Zydus Lifesciences Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Zydus Lifesciences Limited918596198ANALYSIS(65841-799, 65841-800, 65841-801) , MANUFACTURE(65841-799, 65841-800, 65841-801)

Revised: 10/2022
Document Id: 55d15483-b1dd-4901-ae80-e8892bd25e3a
Set id: f36b414e-ace4-4f04-a80f-75bb25db430d
Version: 6
Effective Time: 20221013
 
Zydus Lifesciences Limited