Paroxetine: Package Insert and Label Information (Page 6 of 6)

Package/Label Display Panel – Carton – 10 mg

10 mg Paroxetine Tablets Carton
(click image for full-size original)

NDC 68084- 044 -01

Paroxetine
Tablets, USP

10 mg*

100 Tablets (10 x 10)                Rx Only

PHARMACIST: Dispense with the accompanying Medication
Guide to each patient.

*Each Tablet Contains:
Paroxetine hydrochloride, USP equivalent to paroxetine……..10 mg

Usual Dosage: See package insert for full prescribing information.

Store at 20° to 25°C (68° to 77°F); excursions permitted between
15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Keep this and all drugs out of reach of children.

FOR YOUR PROTECTION: Do not use if blister is torn or broken.

The drug product contained in this package is from
NDC # 68382-097, Zydus Pharmaceuticals (USA) Inc.

Distributed by:
American Health Packaging
Columbus, Ohio 43217

093147 0204401/1018OS

Package/Label Display Panel – Blister – 10 mg

10 mg Paroxetine Tablet Blister
(click image for full-size original)

Paroxetine Tablet, USP

10 mg

Package/Label Display Panel – Carton – 20 mg

20 mg Paroxetine Tablets Carton
(click image for full-size original)

NDC 68084- 045 -01

Paroxetine
Tablets, USP

20 mg*

100 Tablets (10 x 10)                Rx Only

PHARMACIST: Dispense with the accompanying Medication
Guide to each patient.

*Each Tablet Contains:
Paroxetine hydrochloride, USP equivalent to paroxetine…….. 20 mg

Usual Dosage: See package insert for full prescribing information.

Store at 20° to 25°C (68° to 77°F); excursions permitted between
15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Keep this and all drugs out of reach of children.

FOR YOUR PROTECTION: Do not use if blister is torn or broken.

The drug product contained in this package is from
NDC # 68382-098, Zydus Pharmaceuticals (USA) Inc.

Packaged and Distributed by:
American Health Packaging
Columbus, Ohio 43217

094014 0204501/1018A

Package/Label Display Panel – Blister – 20 mg

20 mg Paroxetine Tablet Blister
(click image for full-size original)

Paroxetine Tablet, USP

20 mg

Package/Label Display Panel – Carton – 30 mg

30 mg Paroxetine Tablets Carton
(click image for full-size original)

NDC 68084- 046 -01

Paroxetine
Tablets, USP

30 mg*

100 Tablets (10 x 10)                Rx Only

PHARMACIST: Dispense with the accompanying Medication
Guide to each patient.

*Each Tablet Contains:
Paroxetine hydrochloride, USP equivalent to paroxetine……..30 mg

Usual Dosage: See package insert for full prescribing information.

Store at 20° to 25°C (68° to 77°F); excursions permitted between
15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Keep this and all drugs out of reach of children.

FOR YOUR PROTECTION: Do not use if blister is torn or broken.

The drug product contained in this package is from
NDC # 68382-099, Zydus Pharmaceuticals (USA) Inc.

Distributed by:
American Health Packaging
Columbus, Ohio 43217

094108 0204601/1018OS

Package/Label Display Panel – Blister – 30 mg

30 mg Paroxetine Tablet Blister
(click image for full-size original)

Paroxetine Tablet, USP

30 mg

Package/Label Display Panel – Carton – 40 mg

40 mg Paroxetine Tablets Carton
(click image for full-size original)

NDC 68084- 047 -01

Paroxetine
Tablets, USP

40 mg*

100 Tablets (10 x 10)                Rx Only

PHARMACIST: Dispense with the accompanying Medication
Guide to each patient.

*Each Tablet Contains:
Paroxetine hydrochloride, USP equivalent to paroxetine 40 mg

Usual Dosage: See package insert for full prescribing
information.

Store at 20° to 25°C (68° to 77°F); excursions permitted
between 15° to 30°C (59° to 86°F) [see USP Controlled Room
Temperature].

Keep this and all drugs out of reach of children.

FOR YOUR PROTECTION: Do not use if blister is torn or
broken.

The drug product contained in this package is from
NDC # 68382-001, Zydus Pharmaceuticals (USA) Inc.

Distributed by:
American Health Packaging
Columbus, Ohio 43217

094417 0204701/0918OS

Package/Label Display Panel – Blister – 40 mg

40 mg Paroxetine Tablets Blister
(click image for full-size original)

Paroxetine Tablet, USP

40 mg

PAROXETINE paroxetine hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68084-044(NDC:68382-097)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PAROXETINE HYDROCHLORIDE HEMIHYDRATE (PAROXETINE) PAROXETINE 10 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS DIBASIC CALCIUM PHOSPHATE
HYPROMELLOSE, UNSPECIFIED
ANHYDROUS LACTOSE
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL 6000
POVIDONE, UNSPECIFIED
SODIUM STARCH GLYCOLATE TYPE A POTATO
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:68084-044-01 100 BLISTER PACK in 1 BOX, UNIT-DOSE contains a BLISTER PACK (68084-044-11)
1 NDC:68084-044-11 1 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the BOX, UNIT-DOSE (68084-044-01)
Image of Product
(click image for full-size original)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077584 01/16/2008
PAROXETINE paroxetine hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68084-045(NDC:68382-098)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PAROXETINE HYDROCHLORIDE HEMIHYDRATE (PAROXETINE) PAROXETINE 20 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS DIBASIC CALCIUM PHOSPHATE
HYPROMELLOSE, UNSPECIFIED
ANHYDROUS LACTOSE
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL 6000
POVIDONE, UNSPECIFIED
SODIUM STARCH GLYCOLATE TYPE A POTATO
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:68084-045-01 100 BLISTER PACK in 1 BOX, UNIT-DOSE contains a BLISTER PACK (68084-045-11)
1 NDC:68084-045-11 1 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the BOX, UNIT-DOSE (68084-045-01)
Image of Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077584 03/18/2008
PAROXETINE paroxetine hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68084-046(NDC:68382-099)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PAROXETINE HYDROCHLORIDE HEMIHYDRATE (PAROXETINE) PAROXETINE 30 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS DIBASIC CALCIUM PHOSPHATE
HYPROMELLOSE, UNSPECIFIED
ANHYDROUS LACTOSE
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL 6000
POVIDONE, UNSPECIFIED
SODIUM STARCH GLYCOLATE TYPE A POTATO
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:68084-046-01 100 BLISTER PACK in 1 BOX, UNIT-DOSE contains a BLISTER PACK (68084-046-11)
1 NDC:68084-046-11 1 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the BOX, UNIT-DOSE (68084-046-01)
Image of Product
(click image for full-size original)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077584 01/10/2008
PAROXETINE paroxetine hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68084-047(NDC:68382-001)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PAROXETINE HYDROCHLORIDE HEMIHYDRATE (PAROXETINE) PAROXETINE 40 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS DIBASIC CALCIUM PHOSPHATE
HYPROMELLOSE, UNSPECIFIED
ANHYDROUS LACTOSE
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL 6000
POVIDONE, UNSPECIFIED
SODIUM STARCH GLYCOLATE TYPE A POTATO
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:68084-047-01 100 BLISTER PACK in 1 BOX, UNIT-DOSE contains a BLISTER PACK (68084-047-11)
1 NDC:68084-047-11 1 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the BOX, UNIT-DOSE (68084-047-01)
Image of Product
(click image for full-size original)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077584 06/18/2008
Labeler — American Health Packaging (929561009)
Establishment
Name Address ID/FEI Operations
American Health Packaging 929561009 repack (68084-044), repack (68084-045), repack (68084-046), repack (68084-047)

Revised: 10/2022 American Health Packaging

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