VENLAFAXINE- venlafaxine tablet, extended release 
Zydus Lifesciences Limited

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VENLAFAXINE extended-release tablets, for oral use

SPL MEDGUIDE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Venlafaxine extended-release tablets, 37.5 mg

NDC 70771-1649-3

30 Tablets

Rx only

37.5 mg label

Venlafaxine extended-release tablets, 75 mg

NDC 70771-1650-3

30 Tablets

Rx only

75 mg label

Venlafaxine extended-release tablets, 150 mg

NDC 70771-1651-3

30 Tablets

Rx only

150 mg label

Venlafaxine extended-release tablets, 225 mg

NDC 70771-1652-3

30 Tablets

Rx only

225 mg label
VENLAFAXINE 
venlafaxine tablet, extended release
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1649
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
CELLULOSE ACETATE (UNII: 3J2P07GVB6)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
HYPROMELLOSE 2208 (100 MPA.S) (UNII: B1QE5P712K)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MANNITOL (UNII: 3OWL53L36A)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
POVIDONE K90 (UNII: RDH86HJV5Z)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SHELLAC (UNII: 46N107B71O)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
Product Characteristics
ColorWHITE (off-white) Scoreno score
ShapeROUNDSize6mm
FlavorImprint Code 1348
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1649-330 in 1 BOTTLE; Type 0: Not a Combination Product09/01/2022
2NDC:70771-1649-990 in 1 BOTTLE; Type 0: Not a Combination Product09/01/2022
3NDC:70771-1649-1100 in 1 BOTTLE; Type 0: Not a Combination Product09/01/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21562209/01/2022
VENLAFAXINE 
venlafaxine tablet, extended release
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1650
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
VENLAFAXINE HYDROCHLORIDE (UNII: 7D7RX5A8MO) (VENLAFAXINE - UNII:GRZ5RCB1QG) VENLAFAXINE75 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE ACETATE (UNII: 3J2P07GVB6)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
HYPROMELLOSE 2208 (100 MPA.S) (UNII: B1QE5P712K)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MANNITOL (UNII: 3OWL53L36A)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
POVIDONE K90 (UNII: RDH86HJV5Z)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SHELLAC (UNII: 46N107B71O)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
Product Characteristics
ColorWHITE (off-white) Scoreno score
ShapeROUNDSize8mm
FlavorImprint Code 1349
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1650-330 in 1 BOTTLE; Type 0: Not a Combination Product09/01/2022
2NDC:70771-1650-990 in 1 BOTTLE; Type 0: Not a Combination Product09/01/2022
3NDC:70771-1650-1100 in 1 BOTTLE; Type 0: Not a Combination Product09/01/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21562209/01/2022
VENLAFAXINE 
venlafaxine tablet, extended release
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1651
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
VENLAFAXINE HYDROCHLORIDE (UNII: 7D7RX5A8MO) (VENLAFAXINE - UNII:GRZ5RCB1QG) VENLAFAXINE150 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE ACETATE (UNII: 3J2P07GVB6)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
HYPROMELLOSE 2208 (100 MPA.S) (UNII: B1QE5P712K)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MANNITOL (UNII: 3OWL53L36A)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
POVIDONE K90 (UNII: RDH86HJV5Z)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SHELLAC (UNII: 46N107B71O)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
Product Characteristics
ColorWHITE (off-white) Scoreno score
ShapeROUNDSize10mm
FlavorImprint Code 1350
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1651-330 in 1 BOTTLE; Type 0: Not a Combination Product09/01/2022
2NDC:70771-1651-990 in 1 BOTTLE; Type 0: Not a Combination Product09/01/2022
3NDC:70771-1651-1100 in 1 BOTTLE; Type 0: Not a Combination Product09/01/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21562209/01/2022
VENLAFAXINE 
venlafaxine tablet, extended release
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1652
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
VENLAFAXINE HYDROCHLORIDE (UNII: 7D7RX5A8MO) (VENLAFAXINE - UNII:GRZ5RCB1QG) VENLAFAXINE225 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE ACETATE (UNII: 3J2P07GVB6)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
HYPROMELLOSE 2208 (100 MPA.S) (UNII: B1QE5P712K)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MANNITOL (UNII: 3OWL53L36A)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
POVIDONE K90 (UNII: RDH86HJV5Z)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SHELLAC (UNII: 46N107B71O)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
Product Characteristics
ColorWHITE (off-white) Scoreno score
ShapeROUNDSize12mm
FlavorImprint Code 1352
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1652-330 in 1 BOTTLE; Type 0: Not a Combination Product09/01/2022
2NDC:70771-1652-990 in 1 BOTTLE; Type 0: Not a Combination Product09/01/2022
3NDC:70771-1652-1100 in 1 BOTTLE; Type 0: Not a Combination Product09/01/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21562209/01/2022
Labeler - Zydus Lifesciences Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Zydus Lifesciences Limited863362789ANALYSIS(70771-1649, 70771-1650, 70771-1651, 70771-1652) , MANUFACTURE(70771-1649, 70771-1650, 70771-1651, 70771-1652)

Revised: 9/2023
Document Id: 0bf02fa2-e5cd-42d6-ab41-1ecd150b7c57
Set id: 750333ce-a512-42e1-b9e3-179714b488df
Version: 2
Effective Time: 20230928
 
Zydus Lifesciences Limited