PAROXETINE- paroxetine hydrochloride tablet, film coated 
Zydus Lifesciences Limited

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Paroxetine Tablets, USP

SPL MEDGUIDE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 65841-097-06 in pack count of 30 tablets

Paroxetine Tablets USP, 10 mg

Rx only

30 tablets

Paroxetine tablets, 10 mg

NDC 65841-098-06 in pack count of 30 tablets

Paroxetine Tablets USP, 20 mg

Rx only

30 tablets

Paroxetine tablets, 20 mg

NDC 65841-099-06 in pack count of 30 tablets

Paroxetine Tablets USP, 30 mg

Rx only

30 tablets

Paroxetine tablets, 30 mg

NDC 65841-601-06 in pack count of 30 tablets

Paroxetine Tablets USP, 40 mg

Rx only

30 tablets

Paroxetine tablets, 40 mg
PAROXETINE 
paroxetine hydrochloride tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-097
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PAROXETINE HYDROCHLORIDE ANHYDROUS (UNII: 3I3T11UD2S) (PAROXETINE - UNII:41VRH5220H, PAROXETINE - UNII:41VRH5220H) PAROXETINE10 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
POVIDONE (UNII: FZ989GH94E)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorWHITE (WHITE TO OFF-WHITE) Score2 pieces
ShapeROUND (ROUND) Size6mm
FlavorImprint Code ZC;15
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65841-097-0630 in 1 BOTTLE; Type 0: Not a Combination Product04/13/2007
2NDC:65841-097-1690 in 1 BOTTLE; Type 0: Not a Combination Product04/13/2007
3NDC:65841-097-01100 in 1 BOTTLE; Type 0: Not a Combination Product04/13/2007
4NDC:65841-097-05500 in 1 BOTTLE; Type 0: Not a Combination Product04/13/2007
5NDC:65841-097-101000 in 1 BOTTLE; Type 0: Not a Combination Product04/13/2007
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07758404/13/2007
PAROXETINE 
paroxetine hydrochloride tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-098
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PAROXETINE HYDROCHLORIDE ANHYDROUS (UNII: 3I3T11UD2S) (PAROXETINE - UNII:41VRH5220H, PAROXETINE - UNII:41VRH5220H) PAROXETINE20 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
POVIDONE (UNII: FZ989GH94E)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorWHITE (WHITE TO OFF-WHITE) Score2 pieces
ShapeROUND (ROUND) Size8mm
FlavorImprint Code ZC;16
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65841-098-0630 in 1 BOTTLE; Type 0: Not a Combination Product04/13/2007
2NDC:65841-098-1690 in 1 BOTTLE; Type 0: Not a Combination Product04/13/2007
3NDC:65841-098-01100 in 1 BOTTLE; Type 0: Not a Combination Product04/13/2007
4NDC:65841-098-05500 in 1 BOTTLE; Type 0: Not a Combination Product04/13/2007
5NDC:65841-098-101000 in 1 BOTTLE; Type 0: Not a Combination Product04/13/2007
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07758404/13/2007
PAROXETINE 
paroxetine hydrochloride tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-099
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PAROXETINE HYDROCHLORIDE ANHYDROUS (UNII: 3I3T11UD2S) (PAROXETINE - UNII:41VRH5220H, PAROXETINE - UNII:41VRH5220H) PAROXETINE30 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
POVIDONE (UNII: FZ989GH94E)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorWHITE (WHITE TO OFF-WHITE) Scoreno score
ShapeROUND (ROUND) Size10mm
FlavorImprint Code ZC17
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65841-099-0630 in 1 BOTTLE; Type 0: Not a Combination Product04/13/2007
2NDC:65841-099-1690 in 1 BOTTLE; Type 0: Not a Combination Product04/13/2007
3NDC:65841-099-01100 in 1 BOTTLE; Type 0: Not a Combination Product04/13/2007
4NDC:65841-099-05500 in 1 BOTTLE; Type 0: Not a Combination Product04/13/2007
5NDC:65841-099-101000 in 1 BOTTLE; Type 0: Not a Combination Product04/13/2007
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07758404/13/2007
PAROXETINE 
paroxetine hydrochloride tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-601
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PAROXETINE HYDROCHLORIDE ANHYDROUS (UNII: 3I3T11UD2S) (PAROXETINE - UNII:41VRH5220H, PAROXETINE - UNII:41VRH5220H) PAROXETINE40 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
POVIDONE (UNII: FZ989GH94E)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorWHITE (WHITE TO OFF-WHITE) Scoreno score
ShapeROUND (ROUND) Size11mm
FlavorImprint Code ZC18
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65841-601-0630 in 1 BOTTLE; Type 0: Not a Combination Product04/13/2007
2NDC:65841-601-1690 in 1 BOTTLE; Type 0: Not a Combination Product04/13/2007
3NDC:65841-601-01100 in 1 BOTTLE; Type 0: Not a Combination Product04/13/2007
4NDC:65841-601-05500 in 1 BOTTLE; Type 0: Not a Combination Product04/13/2007
5NDC:65841-601-101000 in 1 BOTTLE; Type 0: Not a Combination Product04/13/2007
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07758404/13/2007
Labeler - Zydus Lifesciences Limited (918596198)
Registrant - Zydus Lifesciences Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Zydus Lifesciences Limited918596198ANALYSIS(65841-097, 65841-098, 65841-099, 65841-601) , MANUFACTURE(65841-097, 65841-098, 65841-099, 65841-601)
Establishment
NameAddressID/FEIBusiness Operations
Zydus Lifesciences Limited677605858MANUFACTURE(65841-097, 65841-098, 65841-099, 65841-601)

Revised: 12/2024
Document Id: ef5c1ef5-2884-4395-a65a-92591c986150
Set id: 6d5fcdb2-4d84-4b20-87e3-58a43e567500
Version: 13
Effective Time: 20241203
 
Zydus Lifesciences Limited