PAROXETINE (Page 9 of 9)

PRINCIPAL DISPLAY PANEL — 10 mg BOTTLE LABEL

NDC 60429-734-30

PAROXETINE TABLETS, USP

10 mg

Rx

30 Tablets

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PRINCIPAL DISPLAY PANEL — 20 mg BOTTLE LABEL

NDC 60429-735-30

PAROXETINE TABLETS, USP

20 mg

Rx

30 Tablets

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PRINCIPAL DISPLAY PANEL — 30 mg BOTTLE LABEL

NDC 60429-736-30

PAROXETINE TABLETS, USP

30 mg

Rx

30 Tablets

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PRINCIPAL DISPLAY PANEL — 40 mg BOTTLE LABEL

NDC 60429-737-30

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:60429-734(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:60429-734-30 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:60429-734-90 90 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:60429-734-10 1000 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075356 07/30/2003
PAROXETINE
paroxetine hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60429-735(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:60429-735-30 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:60429-735-90 90 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:60429-735-10 1000 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075356 07/30/2003
PAROXETINE
paroxetine hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60429-736(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:60429-736-30 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:60429-736-90 90 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:60429-736-10 1000 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075356 07/30/2003
PAROXETINE
paroxetine hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60429-737(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:60429-737-30 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:60429-737-90 90 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:60429-737-10 1000 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075356 07/30/2003
Labeler — Golden State Medical Supply, Inc. (603184490)
Establishment
Name Address ID/FEI Operations
Golden State Medical Supply, Inc. 603184490 relabel (60429-734), repack (60429-734), relabel (60429-735), repack (60429-735), relabel (60429-736), repack (60429-736), relabel (60429-737), repack (60429-737)

Revised: 12/2021 Golden State Medical Supply, Inc.

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