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

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VENLAFAXINE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1836-9

Venlafaxine Hydrochloride Extended-release Capsules USP, 37.5 mg

90 Capsules

Rx only

37.5 mg label

NDC 70771-1837-9

Venlafaxine Hydrochloride Extended-release Capsules USP, 75 mg

90 Capsules

Rx only

75 mg label

NDC 70771-1838-9

Venlafaxine Hydrochloride Extended-release Capsules USP, 150 mg

90 Capsules

Rx only

150 mg label
VENLAFAXINE HYDROCHLORIDE 
venlafaxine hydrochloride capsule, extended release
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1836
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
ETHYLCELLULOSE (7 MPA.S) (UNII: H3UP11403C)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
GELATIN (UNII: 2G86QN327L)  
HYPROMELLOSE 2910 (15 MPA.S) (UNII: 36SFW2JZ0W)  
HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL 8000 (UNII: Q662QK8M3B)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SHELLAC (UNII: 46N107B71O)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorGRAY (grey opaque colored cap) , WHITE (white opaque colored body) Scoreno score
ShapeCAPSULESize16mm
FlavorImprint Code ZA;35;37;5;mg
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1836-990 in 1 BOTTLE; Type 0: Not a Combination Product05/18/2023
2NDC:70771-1836-01000 in 1 BOTTLE; Type 0: Not a Combination Product05/18/2023
3NDC:70771-1836-410 in 1 CARTON05/18/2023
3NDC:70771-1836-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
4NDC:70771-1836-330 in 1 BOTTLE; Type 0: Not a Combination Product05/18/2023
5NDC:70771-1836-5500 in 1 BOTTLE; Type 0: Not a Combination Product05/18/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09017405/18/2023
VENLAFAXINE HYDROCHLORIDE 
venlafaxine hydrochloride capsule, extended release
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1837
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
VENLAFAXINE HYDROCHLORIDE (UNII: 7D7RX5A8MO) (VENLAFAXINE - UNII:GRZ5RCB1QG) VENLAFAXINE75 mg
Inactive Ingredients
Ingredient NameStrength
ETHYLCELLULOSE (7 MPA.S) (UNII: H3UP11403C)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
GELATIN (UNII: 2G86QN327L)  
HYPROMELLOSE 2910 (15 MPA.S) (UNII: 36SFW2JZ0W)  
HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL 8000 (UNII: Q662QK8M3B)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SHELLAC (UNII: 46N107B71O)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorPINK (peach opaque colored cap) , WHITE (white opaque colored body) Scoreno score
ShapeCAPSULESize19mm
FlavorImprint Code ZA;36;75;mg
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1837-5500 in 1 BOTTLE; Type 0: Not a Combination Product05/18/2023
2NDC:70771-1837-01000 in 1 BOTTLE; Type 0: Not a Combination Product05/18/2023
3NDC:70771-1837-410 in 1 CARTON05/18/2023
3NDC:70771-1837-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
4NDC:70771-1837-330 in 1 BOTTLE; Type 0: Not a Combination Product05/18/2023
5NDC:70771-1837-990 in 1 BOTTLE; Type 0: Not a Combination Product05/18/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09017405/18/2023
VENLAFAXINE HYDROCHLORIDE 
venlafaxine hydrochloride capsule, extended release
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1838
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
VENLAFAXINE HYDROCHLORIDE (UNII: 7D7RX5A8MO) (VENLAFAXINE - UNII:GRZ5RCB1QG) VENLAFAXINE150 mg
Inactive Ingredients
Ingredient NameStrength
ETHYLCELLULOSE (7 MPA.S) (UNII: H3UP11403C)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
GELATIN (UNII: 2G86QN327L)  
HYPROMELLOSE 2910 (15 MPA.S) (UNII: 36SFW2JZ0W)  
HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL 8000 (UNII: Q662QK8M3B)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SHELLAC (UNII: 46N107B71O)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorORANGE (dark orange opaque colored cap) , WHITE (white opaque colored body) Scoreno score
ShapeCAPSULESize23mm
FlavorImprint Code ZA;37;150;mg
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1838-330 in 1 BOTTLE; Type 0: Not a Combination Product05/18/2023
2NDC:70771-1838-990 in 1 BOTTLE; Type 0: Not a Combination Product05/18/2023
3NDC:70771-1838-5500 in 1 BOTTLE; Type 0: Not a Combination Product05/18/2023
4NDC:70771-1838-01000 in 1 BOTTLE; Type 0: Not a Combination Product05/18/2023
5NDC:70771-1838-410 in 1 CARTON05/18/2023
5NDC:70771-1838-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09017405/18/2023
Labeler - Zydus Lifesciences Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Zydus Lifesciences Limited918596198ANALYSIS(70771-1836, 70771-1837, 70771-1838) , MANUFACTURE(70771-1836, 70771-1837, 70771-1838)

Revised: 5/2023
Document Id: 665f7293-1792-4b57-b8af-3e1fc33e8200
Set id: 1349bace-d2cb-4c8f-8cbd-c09e67a2ca1b
Version: 1
Effective Time: 20230519
 
Zydus Lifesciences Limited