Paroxetine Hydrochloride (Page 9 of 9)

12.5 mg

NDC 62175-470 -32

Paroxetine

Extended-Release

Tablets, USP

12.5 mg

Print Medication Guides at:

www.lannett.com/med-guide/paroxetine

Rx Only

30 Tablets

25 mg

NDC 62175-471 -32

Paroxetine

Extended-Release

Tablets, USP

25 mg

Print Medication Guides at:

www.lannett.com/med-guide/paroxetine

Rx Only

30 Tablets

37.5 mg

NDC 62175-472 -32

Paroxetine

Extended-Release

Tablets, USP

37.5 mg

Print Medication Guides at:

www.lannett.com/med-guide/paroxetine

Rx Only

30 Tablets

PAROXETINE HYDROCHLORIDE paroxetine hydrochloride tablet, film coated, extended release

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62175-470 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 HYPROMELLOSE 2208 (100 MPA.S) LACTOSE MONOHYDRATE MAGNESIUM STEARATE METHACRYLIC ACID — ETHYL ACRYLATE COPOLYMER (4500 MPA.S) POLYETHYLENE GLYCOL, UNSPECIFIED POLYVINYL ALCOHOL (100000 MW) POVIDONE SILICON DIOXIDE TALC TITANIUM DIOXIDE TRIETHYL CITRATE

Product Characteristics Color white Score no score Shape ROUND Size 9mm Flavor Imprint Code KU;470 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:62175-470-32 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE None 2 NDC:62175-470-41 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA204744 10/31/2014

PAROXETINE HYDROCHLORIDE paroxetine hydrochloride tablet, film coated, extended release

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62175-471 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 FD&C BLUE NO. 2 HYPROMELLOSE 2208 (100 MPA.S) LACTOSE MONOHYDRATE MAGNESIUM STEARATE METHACRYLIC ACID — ETHYL ACRYLATE COPOLYMER (4500 MPA.S) PIGMENT RED 48 POLYETHYLENE GLYCOL, UNSPECIFIED POLYVINYL ALCOHOL (100000 MW) POVIDONE SILICON DIOXIDE TALC TITANIUM DIOXIDE TRIETHYL CITRATE

Product Characteristics Color pink Score no score Shape ROUND Size 9mm Flavor Imprint Code KU;471 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:62175-471-32 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE None 2 NDC:62175-471-41 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA204744 10/31/2014

PAROXETINE HYDROCHLORIDE paroxetine hydrochloride tablet, film coated, extended release

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62175-472 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 FD&C BLUE NO. 2 HYPROMELLOSE 2208 (100 MPA.S) LACTOSE MONOHYDRATE MAGNESIUM STEARATE METHACRYLIC ACID — ETHYL ACRYLATE COPOLYMER (4500 MPA.S) POLYETHYLENE GLYCOL, UNSPECIFIED POLYVINYL ALCOHOL (100000 MW) POVIDONE SILICON DIOXIDE TALC TITANIUM DIOXIDE TRIETHYL CITRATE

Product Characteristics Color blue Score no score Shape ROUND Size 9mm Flavor Imprint Code KU;472 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:62175-472-32 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE None 2 NDC:62175-472-41 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA204744 10/31/2014

Labeler — Lannett Company, Inc. (006422406)

Establishment
Name	Address	ID/FEI	Operations
Lannett Company, Inc.		006422406	manufacture (62175-470), manufacture (62175-471), manufacture (62175-472)

Revised: 10/2021 Lannett Company, Inc.