VENLAFAXINE HYDROCHLORIDE- venlafaxine hydrochloride tablet 
Zydus Lifesciences Limited

----------

Venlafaxine Hydrochloride Tablets

SPL MEDGUIDE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 65841-671-01 in bottle of 100 Tablets

Venlafaxine Hydrochloride Tablets, 25 mg

Rx only

100 TABLETS

 

Venlafaxine Tablets USP, 25 mg

NDC 65841-672-01 in bottle of 100 Tablets

Venlafaxine Hydrochloride Tablets, 37.5 mg

Rx only

100 TABLETS

 

Venlafaxine Tablets USP, 37.5 mg

NDC 65841-673-01 in bottle of 100 Tablets

Venlafaxine Hydrochloride Tablets, 50 mg

Rx only

100 TABLETS

Venlafaxine Tablets USP, 50 mg

NDC 65841-674-01 in bottle of 100 Tablets

Venlafaxine Hydrochloride Tablets, 75 mg

Rx only

100 TABLETS

Venlafaxine Tablets USP, 75 mg

NDC 65841-675-01 in bottle of 100 Tablets

Venlafaxine Hydrochloride Tablets, 100 mg

Rx only

100 TABLETS

Venlafaxine Tablets USP, 100 mg
VENLAFAXINE HYDROCHLORIDE 
venlafaxine hydrochloride tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-671
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
VENLAFAXINE HYDROCHLORIDE (UNII: 7D7RX5A8MO) (VENLAFAXINE - UNII:GRZ5RCB1QG) VENLAFAXINE25 mg
Inactive Ingredients
Ingredient NameStrength
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
Product Characteristics
ColorORANGE (PEACH) Score2 pieces
ShapeROUND (ROUND) Size6mm
FlavorImprint Code ZC;64
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65841-671-0630 in 1 BOTTLE; Type 0: Not a Combination Product06/13/2008
2NDC:65841-671-1460 in 1 BOTTLE; Type 0: Not a Combination Product06/13/2008
3NDC:65841-671-1690 in 1 BOTTLE; Type 0: Not a Combination Product06/13/2008
4NDC:65841-671-01100 in 1 BOTTLE; Type 0: Not a Combination Product06/13/2008
5NDC:65841-671-05500 in 1 BOTTLE; Type 0: Not a Combination Product06/13/2008
6NDC:65841-671-101000 in 1 BOTTLE; Type 0: Not a Combination Product06/13/2008
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07765306/13/2008
VENLAFAXINE HYDROCHLORIDE 
venlafaxine hydrochloride tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-672
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
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
Product Characteristics
ColorORANGE (PEACH) Score2 pieces
ShapeROUND (ROUND) Size7mm
FlavorImprint Code ZC;65
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65841-672-0630 in 1 BOTTLE; Type 0: Not a Combination Product06/13/2008
2NDC:65841-672-1460 in 1 BOTTLE; Type 0: Not a Combination Product06/13/2008
3NDC:65841-672-1690 in 1 BOTTLE; Type 0: Not a Combination Product06/13/2008
4NDC:65841-672-01100 in 1 BOTTLE; Type 0: Not a Combination Product06/13/2008
5NDC:65841-672-05500 in 1 BOTTLE; Type 0: Not a Combination Product06/13/2008
6NDC:65841-672-101000 in 1 BOTTLE; Type 0: Not a Combination Product06/13/2008
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07765306/13/2008
VENLAFAXINE HYDROCHLORIDE 
venlafaxine hydrochloride tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-673
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
VENLAFAXINE HYDROCHLORIDE (UNII: 7D7RX5A8MO) (VENLAFAXINE - UNII:GRZ5RCB1QG) VENLAFAXINE50 mg
Inactive Ingredients
Ingredient NameStrength
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
Product Characteristics
ColorORANGE (PEACH) Score2 pieces
ShapeROUND (ROUND) Size8mm
FlavorImprint Code ZC;66
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65841-673-0630 in 1 BOTTLE; Type 0: Not a Combination Product06/13/2008
2NDC:65841-673-1460 in 1 BOTTLE; Type 0: Not a Combination Product06/13/2008
3NDC:65841-673-1690 in 1 BOTTLE; Type 0: Not a Combination Product06/13/2008
4NDC:65841-673-01100 in 1 BOTTLE; Type 0: Not a Combination Product06/13/2008
5NDC:65841-673-05500 in 1 BOTTLE; Type 0: Not a Combination Product06/13/2008
6NDC:65841-673-101000 in 1 BOTTLE; Type 0: Not a Combination Product06/13/2008
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07765306/13/2008
VENLAFAXINE HYDROCHLORIDE 
venlafaxine hydrochloride tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-674
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
VENLAFAXINE HYDROCHLORIDE (UNII: 7D7RX5A8MO) (VENLAFAXINE - UNII:GRZ5RCB1QG) VENLAFAXINE75 mg
Inactive Ingredients
Ingredient NameStrength
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
Product Characteristics
ColorORANGE (PEACH) Score2 pieces
ShapeROUND (ROUND) Size10mm
FlavorImprint Code ZC;67
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65841-674-0630 in 1 BOTTLE; Type 0: Not a Combination Product06/13/2008
2NDC:65841-674-1460 in 1 BOTTLE; Type 0: Not a Combination Product06/13/2008
3NDC:65841-674-1690 in 1 BOTTLE; Type 0: Not a Combination Product06/13/2008
4NDC:65841-674-01100 in 1 BOTTLE; Type 0: Not a Combination Product06/13/2008
5NDC:65841-674-05500 in 1 BOTTLE; Type 0: Not a Combination Product06/13/2008
6NDC:65841-674-101000 in 1 BOTTLE; Type 0: Not a Combination Product06/13/2008
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07765306/13/2008
VENLAFAXINE HYDROCHLORIDE 
venlafaxine hydrochloride tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-675
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
VENLAFAXINE HYDROCHLORIDE (UNII: 7D7RX5A8MO) (VENLAFAXINE - UNII:GRZ5RCB1QG) VENLAFAXINE100 mg
Inactive Ingredients
Ingredient NameStrength
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
Product Characteristics
ColorORANGE (PEACH) Score2 pieces
ShapeROUND (ROUND) Size10mm
FlavorImprint Code ZC;68
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65841-675-0630 in 1 BOTTLE; Type 0: Not a Combination Product06/13/2008
2NDC:65841-675-1460 in 1 BOTTLE; Type 0: Not a Combination Product06/13/2008
3NDC:65841-675-1690 in 1 BOTTLE; Type 0: Not a Combination Product06/13/2008
4NDC:65841-675-01100 in 1 BOTTLE; Type 0: Not a Combination Product06/13/2008
5NDC:65841-675-05500 in 1 BOTTLE; Type 0: Not a Combination Product06/13/2008
6NDC:65841-675-101000 in 1 BOTTLE; Type 0: Not a Combination Product06/13/2008
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07765306/13/2008
Labeler - Zydus Lifesciences Limited (918596198)

Revised: 9/2023
Document Id: 637bdb70-ec58-4ef7-9bf3-b9977f4f0ccc
Set id: 51334651-7a7f-4653-bf9d-d5be04fd902d
Version: 9
Effective Time: 20230928
 
Zydus Lifesciences Limited