DESVENLAFAXINE- desvenlafaxine tablet, extended release 
Zydus Lifesciences Limited

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DESVENLAFAXINE EXTENDED-RELEASE TABLETS

SPL MEDGUIDE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Desvenlafaxine Extended-release Tablets, 25 mg

NDC 70771-1661-3

30 tablets

Rx only

25 mg

NDC 68382-469-67 in bottle of 14 tablets in unit-of-use package

Desvenlafaxine Extended-release Tablets, 50 mg

14 tablets

Rx  only

Zydus

Desvenlafaxine tablets

NDC 68382-741-67 in bottle of 14 tablets in unit-of-use package

Desvenlafaxine Extended-release Tablets, 100 mg

14 tablets

Rx  only

Zydus

Desvenlafaxine tablets
DESVENLAFAXINE 
desvenlafaxine tablet, extended release
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1311
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DESVENLAFAXINE (UNII: NG99554ANW) (DESVENLAFAXINE - UNII:NG99554ANW) DESVENLAFAXINE50 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
ColorWHITE (WHITE TO OFF-WHITE) Scoreno score
ShapeSQUARE (SQUARE) Size9mm
FlavorImprint Code 469
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1311-330 in 1 BOTTLE; Type 0: Not a Combination Product05/08/201803/25/2025
2NDC:70771-1311-990 in 1 BOTTLE; Type 0: Not a Combination Product05/08/201803/25/2025
3NDC:70771-1311-01000 in 1 BOTTLE; Type 0: Not a Combination Product05/08/201803/25/2025
4NDC:70771-1311-410 in 1 CARTON05/08/201803/25/2025
4NDC:70771-1311-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20402005/08/201804/02/2025
DESVENLAFAXINE 
desvenlafaxine tablet, extended release
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1312
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DESVENLAFAXINE (UNII: NG99554ANW) (DESVENLAFAXINE - UNII:NG99554ANW) DESVENLAFAXINE100 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
ColorORANGE (ORANGE) Scoreno score
ShapeSQUARE (SQUARE) Size9mm
FlavorImprint Code 741
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1312-330 in 1 BOTTLE; Type 0: Not a Combination Product05/08/201803/25/2025
2NDC:70771-1312-990 in 1 BOTTLE; Type 0: Not a Combination Product05/08/201803/25/2025
3NDC:70771-1312-01000 in 1 BOTTLE; Type 0: Not a Combination Product05/08/201803/25/2025
4NDC:70771-1312-410 in 1 CARTON05/08/201803/25/2025
4NDC:70771-1312-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20402005/08/201804/02/2025
DESVENLAFAXINE 
desvenlafaxine tablet, extended release
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1661
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DESVENLAFAXINE (UNII: NG99554ANW) (DESVENLAFAXINE - UNII:NG99554ANW) DESVENLAFAXINE25 mg
Inactive Ingredients
Ingredient NameStrength
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
HYPROMELLOSE 2208 (100 MPA.S) (UNII: B1QE5P712K)  
HYPROMELLOSE 2208 (15000 MPA.S) (UNII: Z78RG6M2N2)  
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE 102 (UNII: PNR0YF693Y)  
POLYETHYLENE GLYCOL 4000 (UNII: 4R4HFI6D95)  
POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
ColorYELLOW (Light Yellow to Yellow) Scoreno score
ShapeSQUARE (Square) Size9mm
FlavorImprint Code 1257
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1661-330 in 1 BOTTLE; Type 0: Not a Combination Product11/30/202203/25/2025
2NDC:70771-1661-990 in 1 BOTTLE; Type 0: Not a Combination Product11/30/202203/25/2025
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20402011/30/202203/25/2025
Labeler - Zydus Lifesciences Limited (918596198)
Registrant - Zydus Lifesciences Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Zydus Lifesciences Limited918596198ANALYSIS(70771-1311, 70771-1312, 70771-1661) , MANUFACTURE(70771-1311, 70771-1312, 70771-1661)

Revised: 4/2025
Document Id: c5702164-60c8-48a6-804b-dcb1bf276974
Set id: 105ef64f-36a7-4eef-8645-ba8dde927689
Version: 9
Effective Time: 20250402
 
Zydus Lifesciences Limited