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 — 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 — 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

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