NDC Code(s) : 42291-579-50, 42291-580-50, 42291-581-30
Packager : AvKARE, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Paroxetine HydrochlorideParoxetine Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42291-579(NDC:62175-470)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PAROXETINE HYDROCHLORIDE HEMIHYDRATE(UNII: X2ELS050D8)
(PAROXETINE - UNII:41VRH5220H) 		PAROXETINE12.5 mg
Inactive Ingredients
Ingredient Name Strength
POLYETHYLENE GLYCOLS(UNII: 3WJQ0SDW1A)
POLYVINYL ALCOHOL (100000 MW)(UNII: 949E52Z6MY)
POVIDONE(UNII: FZ989GH94E)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
TRIETHYL CITRATE(UNII: 8Z96QXD6UM)
HYPROMELLOSE 2208 (100 MPA.S)(UNII: B1QE5P712K)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (4500 MPA.S)(UNII: T967IEU43C)
Product Characteristics
Color white Score no score
Shape ROUND Size 9 mm
Flavor Imprint Code KU;470
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:42291-579-50500 in 1 BOTTLE Type 0: Not a Combination Product11/02/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204744 11/02/2016
Paroxetine HydrochlorideParoxetine Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42291-580(NDC:62175-471)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PAROXETINE HYDROCHLORIDE HEMIHYDRATE(UNII: X2ELS050D8)
(PAROXETINE - UNII:41VRH5220H) 		PAROXETINE25 mg
Inactive Ingredients
Ingredient Name Strength
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
HYPROMELLOSE 2208 (100 MPA.S)(UNII: B1QE5P712K)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (4500 MPA.S)(UNII: T967IEU43C)
PIGMENT RED 48(UNII: 07XHK4SAV6)
POLYETHYLENE GLYCOLS(UNII: 3WJQ0SDW1A)
POLYVINYL ALCOHOL (100000 MW)(UNII: 949E52Z6MY)
POVIDONE(UNII: FZ989GH94E)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
TRIETHYL CITRATE(UNII: 8Z96QXD6UM)
Product Characteristics
Color pink Score no score
Shape ROUND Size 9 mm
Flavor Imprint Code KU;471
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:42291-580-50500 in 1 BOTTLE Type 0: Not a Combination Product11/02/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204744 11/02/2016
Paroxetine HydrochlorideParoxetine Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42291-581(NDC:62175-472)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PAROXETINE HYDROCHLORIDE HEMIHYDRATE(UNII: X2ELS050D8)
(PAROXETINE - UNII:41VRH5220H) 		PAROXETINE37.5 mg
Inactive Ingredients
Ingredient Name Strength
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
HYPROMELLOSE 2208 (100 MPA.S)(UNII: B1QE5P712K)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (4500 MPA.S)(UNII: T967IEU43C)
POLYETHYLENE GLYCOLS(UNII: 3WJQ0SDW1A)
POLYVINYL ALCOHOL (100000 MW)(UNII: 949E52Z6MY)
POVIDONE(UNII: FZ989GH94E)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
TRIETHYL CITRATE(UNII: 8Z96QXD6UM)
Product Characteristics
Color blue Score no score
Shape ROUND Size 9 mm
Flavor Imprint Code KU;472
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:42291-581-3030 in 1 BOTTLE Type 0: Not a Combination Product11/02/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204744 11/02/2016

PRINCIPAL DISPLAY PANEL

AVKARE
NDC 42291-579-50
Paroxetine Extended-Release Tablets, USP
12.5 mg
500 Tablets           Rx Only

Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature].

Each film-coated, extended-release tablet contains paroxetine hydrochloride equivalent to 12.5mg paroxetine.

Usual Dosage: See accompanying prescribing information.

Important: Use safety closures when dispensing this product unless otherwise directed by physician or requested by purchaser.

Swallow tablets whole.
Do not chew or crush the tablets.
KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.

Manufactured for:
AvKARE, Inc.
Pulaski, TN 38478

Mfg. Rev. 04/16       AV 10/16 (P)

N3 42291 57950 7

label 1

AVKARE
NDC 42291-580-50
Paroxetine Extended-Release Tablets, USP
25 mg
500 Tablets     Rx Only

Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature].

Each film-coated, extended-release tablet contains paroxetine hydrochloride equivalent to 25mg paroxetine.

Usual Dosage: See accompanying prescribing information.

Important: Use safety closures when dispensing this product unless otherwise directed by physician or requested by purchaser.

Swallow tablets whole.
Do not chew or crush the tablets.
KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.

Manufactured for:
AvKARE, Inc.
Pulaski, TN 38478

Mfg. Rev. 04/16        AV 10/16 (P)

N3 42291 58050 3

label 1

AVKARE
NDC 42291-581-30
Paroxetine Extended-Release Tablets, USP
37.5 mg
30 Tablets    Rx Only

Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature].

Each film-coated, extended-release tablet contains paroxetine hydrochloride equivalent to 37.5mg paroxetine.

Usual Dosage: See accompanying prescribing information.

Important: Use safety closures when dispensing this product unless otherwise directed by physician or requested by purchaser.

Swallow tablets whole.
Do not chew or crush the tablets.
KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.

Manufactured for:
AvKARE, Inc.
Pulaski, TN 38478

Mfg. Rev. 04/16        AV 10/16 (P)

N3 42291 58130 2

label 1