VENLAFAXINE HYDROCHLORIDE- venlafaxine hydrochloride capsule, extended release 
Zydus Lifesciences Limited

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VENLAFAXINE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES

SPL MEDGUIDE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 65841-751-10

Venlafaxine Hydrochloride Extended-release Capsules USP, 37.5 mg

1000 Capsules

Rx only

Venlafaxine hydrochloride extended-release capsules, USP

NDC 65841-752-10

Venlafaxine Hydrochloride Extended-release Capsules USP, 75 mg

1000 Capsules

Rx only

Venlafaxine hydrochloride extended-release capsules, USP

NDC 65841-753-10

Venlafaxine Hydrochloride Extended-release Capsules USP, 150 mg

1000 Capsules

Rx only

Venlafaxine hydrochloride extended-release capsules, USP
VENLAFAXINE HYDROCHLORIDE 
venlafaxine hydrochloride capsule, extended release
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-751
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
VENLAFAXINE HYDROCHLORIDE (UNII: 7D7RX5A8MO) (VENLAFAXINE - UNII:GRZ5RCB1QG) VENLAFAXINE37.5 mg
Inactive Ingredients
Ingredient NameStrength
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
GELATIN (UNII: 2G86QN327L)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
ETHYL ACRYLATE AND METHYL METHACRYLATE COPOLYMER (2:1; 750000 MW) (UNII: P2OM2Q86BI)  
Product Characteristics
ColorGRAY (GRAY) , WHITE (WHITE) Scoreno score
ShapeCAPSULE (CAPSULE) Size16mm
FlavorImprint Code ZA;35;37;5;mg
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65841-751-0630 in 1 BOTTLE; Type 0: Not a Combination Product06/01/2011
2NDC:65841-751-1690 in 1 BOTTLE; Type 0: Not a Combination Product06/01/2011
3NDC:65841-751-101000 in 1 BOTTLE; Type 0: Not a Combination Product06/01/2011
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09017406/01/2011
VENLAFAXINE HYDROCHLORIDE 
venlafaxine hydrochloride capsule, extended release
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-752
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
VENLAFAXINE HYDROCHLORIDE (UNII: 7D7RX5A8MO) (VENLAFAXINE - UNII:GRZ5RCB1QG) VENLAFAXINE75 mg
Inactive Ingredients
Ingredient NameStrength
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
GELATIN (UNII: 2G86QN327L)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
ETHYL ACRYLATE AND METHYL METHACRYLATE COPOLYMER (2:1; 750000 MW) (UNII: P2OM2Q86BI)  
Product Characteristics
ColorORANGE (PEACH) , WHITE (WHITE) Scoreno score
ShapeCAPSULE (CAPSULE) Size20mm
FlavorImprint Code ZA;36;75;mg
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65841-752-0630 in 1 BOTTLE; Type 0: Not a Combination Product06/01/2011
2NDC:65841-752-1690 in 1 BOTTLE; Type 0: Not a Combination Product06/01/2011
3NDC:65841-752-101000 in 1 BOTTLE; Type 0: Not a Combination Product06/01/2011
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09017406/01/2011
VENLAFAXINE HYDROCHLORIDE 
venlafaxine hydrochloride capsule, extended release
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-753
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
VENLAFAXINE HYDROCHLORIDE (UNII: 7D7RX5A8MO) (VENLAFAXINE - UNII:GRZ5RCB1QG) VENLAFAXINE150 mg
Inactive Ingredients
Ingredient NameStrength
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
GELATIN (UNII: 2G86QN327L)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
ETHYL ACRYLATE AND METHYL METHACRYLATE COPOLYMER (2:1; 750000 MW) (UNII: P2OM2Q86BI)  
Product Characteristics
ColorORANGE (DARK ORANGE) , WHITE (WHITE) Scoreno score
ShapeCAPSULE (CAPSULE) Size21mm
FlavorImprint Code ZA;37;150;mg
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65841-753-0630 in 1 BOTTLE; Type 0: Not a Combination Product06/01/2011
2NDC:65841-753-1690 in 1 BOTTLE; Type 0: Not a Combination Product06/01/2011
3NDC:65841-753-101000 in 1 BOTTLE; Type 0: Not a Combination Product06/01/2011
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09017406/01/2011
Labeler - Zydus Lifesciences Limited (918596198)
Registrant - Zydus Lifesciences Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Zydus Lifesciences Limited918596198ANALYSIS(65841-751, 65841-752, 65841-753) , MANUFACTURE(65841-751, 65841-752, 65841-753)

Revised: 9/2023
Document Id: f20749dc-d1f6-4860-b583-82b82d3a2242
Set id: 1be1be3a-304b-4e31-8732-335247029191
Version: 10
Effective Time: 20230928
 
Zydus Lifesciences Limited