Paroxetine (Page 9 of 9)

PRINCIPAL DISPLAY PANEL — Container Label — 10 mg container label image

NDC 52817-140 -90

Paroxetine
Tablets, USP

10 mg

PHARMACIST: Dispense the accompanying Medication Guide to each patient.

TruPharma

Rx only

90 Scored Tablets

Container Label-10 mg
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — Container Label — 20 mg container label image

NDC 52817-141 -90

Paroxetine
Tablets, USP

20 mg

PHARMACIST: Dispense the accompanying Medication Guide to each patient.

TruPharma

Rx only

90 Scored Tablets

Container Label-20 mg
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — Container Label — 30 mg container label image

NDC 52817-142 -90

Paroxetine
Tablets, USP

30 mg

PHARMACIST: Dispense the accompanyingMedication Guide to each patient.

TruPharma

Rx only

90 Tablets

Container Label-30 mg
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — Container Label — 40 mg container label image

NDC 52817-143 -90

Paroxetine
Tablets, USP

40 mg

PHARMACIST: Dispense the accompanying Medication Guide to each patient.

TruPharma

Rx only

90 Tablets

Container Label-40 mg
(click image for full-size original)

PAROXETINE paroxetine hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52817-140
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PAROXETINE HYDROCHLORIDE ANHYDROUS (PAROXETINE) PAROXETINE 10 mg
Inactive Ingredients
Ingredient Name Strength
HYPROMELLOSES
GLYCERYL DIBEHENATE
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
TITANIUM DIOXIDE
POLYETHYLENE GLYCOLS
FERRIC OXIDE YELLOW
FERRIC OXIDE RED
Product Characteristics
Color BROWN (beige to light brown) Score 2 pieces
Shape CAPSULE Size 9mm
Flavor Imprint Code T1
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:52817-140-90 90 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:52817-140-50 500 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203854 09/30/2016
PAROXETINE paroxetine hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52817-141
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PAROXETINE HYDROCHLORIDE ANHYDROUS (PAROXETINE) PAROXETINE 20 mg
Inactive Ingredients
Ingredient Name Strength
HYPROMELLOSES
GLYCERYL DIBEHENATE
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
TITANIUM DIOXIDE
POLYETHYLENE GLYCOLS
FERRIC OXIDE YELLOW
FERRIC OXIDE RED
Product Characteristics
Color BROWN (beige to light brown) Score 2 pieces
Shape CAPSULE Size 12mm
Flavor Imprint Code T2
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:52817-141-90 90 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:52817-141-00 1000 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203854 09/30/2016
PAROXETINE paroxetine hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52817-142
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PAROXETINE HYDROCHLORIDE ANHYDROUS (PAROXETINE) PAROXETINE 30 mg
Inactive Ingredients
Ingredient Name Strength
HYPROMELLOSES
GLYCERYL DIBEHENATE
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
TITANIUM DIOXIDE
POLYETHYLENE GLYCOLS
FERRIC OXIDE YELLOW
FERRIC OXIDE RED
Product Characteristics
Color BROWN (beige to light brown) Score no score
Shape CAPSULE Size 13mm
Flavor Imprint Code T3
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:52817-142-90 90 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:52817-142-50 500 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203854 09/30/2016
PAROXETINE paroxetine hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52817-143
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PAROXETINE HYDROCHLORIDE ANHYDROUS (PAROXETINE) PAROXETINE 40 mg
Inactive Ingredients
Ingredient Name Strength
HYPROMELLOSES
GLYCERYL DIBEHENATE
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
TITANIUM DIOXIDE
POLYETHYLENE GLYCOLS
FERRIC OXIDE YELLOW
FERRIC OXIDE RED
Product Characteristics
Color BROWN (beige to light brown) Score no score
Shape CAPSULE Size 14mm
Flavor Imprint Code T4
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:52817-143-90 90 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:52817-143-50 500 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203854 09/30/2016
Labeler — Trupharma, LLC (078533947)
Registrant — Prinston Pharmaceutical Inc. (967289799)
Establishment
Name Address ID/FEI Operations
Zhejiang Huahai Pharmaceutical Co. Ltd 530732460 MANUFACTURE (52817-140), MANUFACTURE (52817-141), MANUFACTURE (52817-142), MANUFACTURE (52817-143)

Revised: 09/2016 Trupharma, LLC

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