Prescription Drug Information: Paroxetine (Page 6 of 6)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Paroxetine Extended-Release Tablets — Container Label 30 Tablets
NDC 71209-094 -01
Paroxetine Extended-Release Tablets
12.5 mg

Pharmacist: Dispense the accompanying Medication Guide to each patient. RX only 30 Tablets

cont-label-12-5mg-30-tab
(click image for full-size original)

Paroxetine Extended-Release Tablets — Container Label 500 Tablets
NDC 71209- 094 -10
Paroxetine Extended-Release Tablets
12.5 mg

Pharmacist: Dispense the accompanying Medication Guide to each patient. RX only 500 Tablets

cont-label-12-5mg-500-tab
(click image for full-size original)

Paroxetine Extended-Release Tablets — Container Label 30 Tablets
NDC 71209- 095 -01
Paroxetine Extended-Release Tablets
25 mg

Pharmacist: Dispense the accompanying Medication Guide to each patient. RX only 30 Tablets

cont-label-25mg-30-tab
(click image for full-size original)

Paroxetine Extended-Release Tablets — Container Label 500 Tablets
NDC 71209- 095 -10
Paroxetine Extended-Release Tablets
25 mg

Pharmacist: Dispense the accompanying Medication Guide to each patient. RX only 500 Tablets

cont-label-25mg-500-tab
(click image for full-size original)

Paroxetine Extended-Release Tablets — Container Label 30 Tablets
NDC 71209- 096 -01
Paroxetine Extended-Release Tablets
37.5 mg

Pharmacist: Dispense the accompanying Medication Guide to each patient. RX only 30 Tablets

cont-label-37-5mg-30-tab
(click image for full-size original)

Paroxetine Extended-Release Tablets — Container Label 500 Tablets
NDC 71209-096 -10
Paroxetine Extended-Release Tablets
37.5 mg

Pharmacist: Dispense the accompanying Medication Guide to each patient. RX only 500 Tablets

cont-label-37-5mg-500-tab
(click image for full-size original)
PAROXETINE paroxetine tablet, film coated, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71209-094
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PAROXETINE HYDROCHLORIDE HEMIHYDRATE (PAROXETINE) PAROXETINE 12.5 mg
Inactive Ingredients
Ingredient Name Strength
FERRIC OXIDE YELLOW
GLYCERYL DIBEHENATE
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POLYSORBATE 80
SILICON DIOXIDE
SODIUM LAURYL SULFATE
TALC
TITANIUM DIOXIDE
TRIETHYL CITRATE
METHACRYLIC ACID — ETHYL ACRYLATE COPOLYMER (1:1) TYPE A
POVIDONE K30
POLYETHYLENE GLYCOL, UNSPECIFIED
HYPROMELLOSES
Product Characteristics
Color YELLOW Score no score
Shape ROUND Size 7mm
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:71209-094-01 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE None
2 NDC:71209-094-10 500 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 ANDA212645 02/14/2020
PAROXETINE paroxetine tablet, film coated, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71209-095
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PAROXETINE HYDROCHLORIDE HEMIHYDRATE (PAROXETINE) PAROXETINE 25 mg
Inactive Ingredients
Ingredient Name Strength
FERRIC OXIDE YELLOW
GLYCERYL DIBEHENATE
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POLYSORBATE 80
SILICON DIOXIDE
SODIUM LAURYL SULFATE
TALC
TITANIUM DIOXIDE
TRIETHYL CITRATE
METHACRYLIC ACID — ETHYL ACRYLATE COPOLYMER (1:1) TYPE A
POVIDONE K30
POLYETHYLENE GLYCOL, UNSPECIFIED
HYPROMELLOSES
Product Characteristics
Color PINK Score no score
Shape ROUND Size 7mm
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:71209-095-01 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE None
2 NDC:71209-095-10 500 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 ANDA212645 02/14/2020
PAROXETINE paroxetine tablet, film coated, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71209-096
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PAROXETINE HYDROCHLORIDE HEMIHYDRATE (PAROXETINE) PAROXETINE 37.5 mg
Inactive Ingredients
Ingredient Name Strength
FERRIC OXIDE YELLOW
GLYCERYL DIBEHENATE
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POLYSORBATE 80
SILICON DIOXIDE
SODIUM LAURYL SULFATE
TALC
TITANIUM DIOXIDE
TRIETHYL CITRATE
METHACRYLIC ACID — ETHYL ACRYLATE COPOLYMER (1:1) TYPE A
POVIDONE K30
POLYETHYLENE GLYCOL, UNSPECIFIED
HYPROMELLOSES
Product Characteristics
Color BLUE Score no score
Shape ROUND Size 8mm
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:71209-096-01 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE None
2 NDC:71209-096-10 500 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 ANDA212645 02/14/2020
Labeler — Cadila Pharmaceuticals Limited (862257719)
Establishment
Name Address ID/FEI Operations
Cadila Pharmaceuticals Limited 918451696 ANALYSIS (71209-094), ANALYSIS (71209-095), ANALYSIS (71209-096), LABEL (71209-094), LABEL (71209-095), LABEL (71209-096), MANUFACTURE (71209-094), MANUFACTURE (71209-095), MANUFACTURE (71209-096), PACK (71209-094), PACK (71209-095), PACK (71209-096)

Revised: 09/2021 Cadila Pharmaceuticals Limited

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