Paroxetine

PAROXETINE — paroxetine hydrochloride anhydrous tablet, film coated
Zydus Lifesciences Limited

SPL MEDGUIDE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 65841-097-05 in pack count of 500 tablets

Paroxetine Tablets USP, 10 mg

R_x only

500 tablets

NDC 65841-098-16 in pack count of 90 tablets

Paroxetine Tablets USP, 20 mg

R_x only

90 tablets

NDC 65841-099-10 in pack count of 1000 tablets

Paroxetine Tablets USP, 30 mg

R_x only

1000 tablets

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

Paroxetine Tablets USP, 40 mg

R_x only

30 tablets

PAROXETINE paroxetine hydrochloride tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-097 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PAROXETINE HYDROCHLORIDE ANHYDROUS (PAROXETINE and PAROXETINE) PAROXETINE 10 mg

Inactive Ingredients Ingredient Name Strength ANHYDROUS DIBASIC CALCIUM PHOSPHATE ANHYDROUS LACTOSE HYPROMELLOSES MAGNESIUM STEARATE POLYETHYLENE GLYCOL 6000 SODIUM STARCH GLYCOLATE TYPE A POTATO POVIDONE TALC TITANIUM DIOXIDE

Product Characteristics Color WHITE (WHITE TO OFF-WHITE) Score 2 pieces Shape ROUND (ROUND) Size 6mm Flavor Imprint Code ZC;15 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:65841-097-06 30 TABLET, FILM COATED in 1 BOTTLE None 2 NDC:65841-097-16 90 TABLET, FILM COATED in 1 BOTTLE None 3 NDC:65841-097-01 100 TABLET, FILM COATED in 1 BOTTLE None 4 NDC:65841-097-05 500 TABLET, FILM COATED in 1 BOTTLE None 5 NDC:65841-097-10 1000 TABLET, FILM COATED in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA077584 04/13/2007

PAROXETINE paroxetine hydrochloride tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-098 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PAROXETINE HYDROCHLORIDE ANHYDROUS (PAROXETINE and PAROXETINE) PAROXETINE 20 mg

Inactive Ingredients Ingredient Name Strength ANHYDROUS DIBASIC CALCIUM PHOSPHATE ANHYDROUS LACTOSE HYPROMELLOSES MAGNESIUM STEARATE POLYETHYLENE GLYCOL 6000 SODIUM STARCH GLYCOLATE TYPE A POTATO POVIDONE TALC TITANIUM DIOXIDE

Product Characteristics Color WHITE (WHITE TO OFF-WHITE) Score 2 pieces Shape ROUND (ROUND) Size 8mm Flavor Imprint Code ZC;16 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:65841-098-06 30 TABLET, FILM COATED in 1 BOTTLE None 2 NDC:65841-098-16 90 TABLET, FILM COATED in 1 BOTTLE None 3 NDC:65841-098-01 100 TABLET, FILM COATED in 1 BOTTLE None 4 NDC:65841-098-05 500 TABLET, FILM COATED in 1 BOTTLE None 5 NDC:65841-098-10 1000 TABLET, FILM COATED in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA077584 04/13/2007

PAROXETINE paroxetine hydrochloride tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-099 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PAROXETINE HYDROCHLORIDE ANHYDROUS (PAROXETINE and PAROXETINE) PAROXETINE 30 mg

Inactive Ingredients Ingredient Name Strength ANHYDROUS DIBASIC CALCIUM PHOSPHATE ANHYDROUS LACTOSE HYPROMELLOSES MAGNESIUM STEARATE POLYETHYLENE GLYCOL 6000 SODIUM STARCH GLYCOLATE TYPE A POTATO POVIDONE TALC TITANIUM DIOXIDE

Product Characteristics Color WHITE (WHITE TO OFF-WHITE) Score no score Shape ROUND (ROUND) Size 10mm Flavor Imprint Code ZC17 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:65841-099-06 30 TABLET, FILM COATED in 1 BOTTLE None 2 NDC:65841-099-16 90 TABLET, FILM COATED in 1 BOTTLE None 3 NDC:65841-099-01 100 TABLET, FILM COATED in 1 BOTTLE None 4 NDC:65841-099-05 500 TABLET, FILM COATED in 1 BOTTLE None 5 NDC:65841-099-10 1000 TABLET, FILM COATED in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA077584 04/13/2007

PAROXETINE paroxetine hydrochloride tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-601 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PAROXETINE HYDROCHLORIDE ANHYDROUS (PAROXETINE and PAROXETINE) PAROXETINE 40 mg

Inactive Ingredients Ingredient Name Strength ANHYDROUS DIBASIC CALCIUM PHOSPHATE ANHYDROUS LACTOSE HYPROMELLOSES MAGNESIUM STEARATE POLYETHYLENE GLYCOL 6000 SODIUM STARCH GLYCOLATE TYPE A POTATO POVIDONE TALC TITANIUM DIOXIDE

Product Characteristics Color WHITE (WHITE TO OFF-WHITE) Score no score Shape ROUND (ROUND) Size 11mm Flavor Imprint Code ZC18 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:65841-601-06 30 TABLET, FILM COATED in 1 BOTTLE None 2 NDC:65841-601-16 90 TABLET, FILM COATED in 1 BOTTLE None 3 NDC:65841-601-01 100 TABLET, FILM COATED in 1 BOTTLE None 4 NDC:65841-601-05 500 TABLET, FILM COATED in 1 BOTTLE None 5 NDC:65841-601-10 1000 TABLET, FILM COATED in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA077584 04/13/2007

Labeler — Zydus Lifesciences Limited (918596198)

Registrant — Zydus Lifesciences Limited (918596198)

Establishment
Name	Address	ID/FEI	Operations
Zydus Lifesciences Limited		918596198	ANALYSIS (65841-097), ANALYSIS (65841-098), ANALYSIS (65841-099), ANALYSIS (65841-601), MANUFACTURE (65841-097), MANUFACTURE (65841-098), MANUFACTURE (65841-099), MANUFACTURE (65841-601)

Establishment
Name	Address	ID/FEI	Operations
Zydus Lifesciences Limited		677605858	MANUFACTURE (65841-097), MANUFACTURE (65841-098), MANUFACTURE (65841-099), MANUFACTURE (65841-601)

Revised: 10/2022 Zydus Lifesciences Limited