Paroxetine (Page 8 of 8)

PRINCIPAL DISPLAY PANEL — 12.5 mg Tablet Bottle Label

NDC 69367-335-30

Rx Only

Paroxetine Extended-
Release Tablets, USP

12.5 mg

PHARMACIST: Dispense with Medication
Guide provided separately to each patient.

30 Tablets

WestminsterPharmaceuticals

PRINCIPAL DISPLAY PANEL -- 12.5 mg Tablet Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 25 mg Tablet Bottle Label

NDC 69367-336-30

Rx Only

Paroxetine Extended-
Release Tablets, USP

25 mg

PHARMACIST: Dispense with Medication
Guide provided separately to each patient.

30 Tablets

WestminsterPharmaceuticals

PRINCIPAL DISPLAY PANEL -- 25 mg Tablet Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 37.5 mg Tablet Bottle Label

NDC 69367-337-30

Rx Only

Paroxetine Extended-
Release Tablets, USP

37.5 mg

PHARMACIST: Dispense with Medication
Guide provided separately to each patient.

30 Tablets

WestminsterPharmaceuticals

PRINCIPAL DISPLAY PANEL -- 37.5 mg Tablet Bottle Label
(click image for full-size original)
PAROXETINE paroxetine tablet, film coated, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69367-335
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PAROXETINE HYDROCHLORIDE (PAROXETINE) PAROXETINE 12.5 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
HYPROMELLOSE, UNSPECIFIED
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
FERRIC OXIDE YELLOW
GLYCERYL DIBEHENATE
D&C YELLOW NO. 10 ALUMINUM LAKE
FD&C BLUE NO. 2–ALUMINUM LAKE
FD&C RED NO. 40
FD&C YELLOW NO. 6
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYSORBATE 80
SODIUM LAURYL SULFATE
TALC
TITANIUM DIOXIDE
TRIETHYL CITRATE
Product Characteristics
Color YELLOW Score no score
Shape ROUND Size 7mm
Flavor Imprint Code v11
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69367-335-30 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA213485 07/26/2021
PAROXETINE paroxetine tablet, film coated, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69367-336
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PAROXETINE HYDROCHLORIDE (PAROXETINE) PAROXETINE 25 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
HYPROMELLOSE, UNSPECIFIED
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
FERRIC OXIDE YELLOW
GLYCERYL DIBEHENATE
FERRIC OXIDE RED
FERROSOFERRIC OXIDE
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYSORBATE 80
SODIUM LAURYL SULFATE
TALC
TITANIUM DIOXIDE
TRIETHYL CITRATE
Product Characteristics
Color PINK Score no score
Shape ROUND Size 7mm
Flavor Imprint Code v12
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69367-336-30 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA213485 07/26/2021
PAROXETINE paroxetine tablet, film coated, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69367-337
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PAROXETINE HYDROCHLORIDE (PAROXETINE) PAROXETINE 37.5 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
HYPROMELLOSE, UNSPECIFIED
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
FERRIC OXIDE YELLOW
GLYCERYL DIBEHENATE
FD&C BLUE NO. 2–ALUMINUM LAKE
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYSORBATE 80
SODIUM LAURYL SULFATE
TALC
TITANIUM DIOXIDE
TRIETHYL CITRATE
Product Characteristics
Color BLUE Score no score
Shape ROUND Size 8mm
Flavor Imprint Code v13
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69367-337-30 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA213485 07/26/2021
Labeler — Westminster Pharmaceuticals, LLC (079516651)
Establishment
Name Address ID/FEI Operations
Visum Pharmaceutical Co. 421344638 MANUFACTURE (69367-335), MANUFACTURE (69367-336), MANUFACTURE (69367-337)

Revised: 10/2021 Westminster Pharmaceuticals, LLC

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