PAROXETINE (Page 9 of 9)

PRINCIPAL DISPLAY PANEL — 10 mg BOTTLE LABEL

APOTEX CORP. NDC 60505-0097-1

PAROXETINE TABLETS, USP

10 mg

Rx

30 Tablets

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PRINCIPAL DISPLAY PANEL — 20 mg BOTTLE LABEL

APOTEX CORP. NDC 60505-0083-1

PAROXETINE TABLETS, USP

20 mg

Rx

30 Tablets

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PRINCIPAL DISPLAY PANEL — 30 mg BOTTLE LABEL

APOTEX CORP. NDC 60505-0084-1

PAROXETINE TABLETS, USP

30 mg

Rx

30 Tablets

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PRINCIPAL DISPLAY PANEL — 40 mg BOTTLE LABEL

APOTEX CORP. NDC 60505-0101-1

PAROXETINE TABLETS, USP

40 mg

Rx

30 Tablets

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PAROXETINE
paroxetine hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60505-0097
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
ANHYDROUS LACTOSE
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
HYPROMELLOSE, UNSPECIFIED
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL 8000
SODIUM STARCH GLYCOLATE TYPE A POTATO
TITANIUM DIOXIDE
Product Characteristics
Color WHITE Score 2 pieces
Shape OVAL Size 9mm
Flavor Imprint Code APO;097
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:60505-0097-1 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:60505-0097-9 90 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:60505-0097-2 100 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:60505-0097-4 1000 TABLET, FILM COATED in 1 BOTTLE None
5 NDC:60505-0097-7 18000 TABLET, FILM COATED in 1 BOTTLE None
6 NDC:60505-0097-5 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK
6 10 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (60505-0097-5)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075356 09/08/2003
PAROXETINE
paroxetine hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60505-0083
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
ANHYDROUS LACTOSE
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
HYPROMELLOSE, UNSPECIFIED
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL 8000
SODIUM STARCH GLYCOLATE TYPE A POTATO
TITANIUM DIOXIDE
Product Characteristics
Color WHITE Score 2 pieces
Shape OVAL Size 11mm
Flavor Imprint Code APO;083
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:60505-0083-1 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:60505-0083-9 90 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:60505-0083-2 100 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:60505-0083-4 1000 TABLET, FILM COATED in 1 BOTTLE None
5 NDC:60505-0083-0 12500 TABLET, FILM COATED in 1 BOTTLE None
6 NDC:60505-0083-5 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK
6 10 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (60505-0083-5)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075356 09/08/2003
PAROXETINE
paroxetine hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60505-0084
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
ANHYDROUS LACTOSE
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
HYPROMELLOSE, UNSPECIFIED
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL 8000
SODIUM STARCH GLYCOLATE TYPE A POTATO
TITANIUM DIOXIDE
Product Characteristics
Color WHITE Score no score
Shape OVAL Size 13mm
Flavor Imprint Code APO;084
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:60505-0084-1 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:60505-0084-9 90 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:60505-0084-2 100 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:60505-0084-4 1000 TABLET, FILM COATED in 1 BOTTLE None
5 NDC:60505-0084-5 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK
5 10 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (60505-0084-5)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075356 09/08/2003
PAROXETINE
paroxetine hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60505-0101
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
ANHYDROUS LACTOSE
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
HYPROMELLOSE, UNSPECIFIED
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL 8000
SODIUM STARCH GLYCOLATE TYPE A POTATO
TITANIUM DIOXIDE
Product Characteristics
Color WHITE Score no score
Shape OVAL Size 14mm
Flavor Imprint Code APO;101
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:60505-0101-1 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:60505-0101-9 90 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:60505-0101-2 100 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:60505-0101-4 1000 TABLET, FILM COATED in 1 BOTTLE None
5 NDC:60505-0101-5 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK
5 10 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (60505-0101-5)
6 NDC:60505-0101-7 7000 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075356 09/08/2003
Labeler — Apotex Corp. (845263701)
Registrant — Apotex Inc. (209429182)

Revised: 09/2023 Apotex Corp.

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