Paliperidone (Page 10 of 10)

PRINCIPAL DISPLAY PANEL — 1.5 mg Tablet Bottle Label

NDC 27808-222-01

Paliperidone
Extended-Release Tablets

1.5mg

Tablets should be swallowed whole.
Do not divide, crush, or chew.
Paliperidone should be taken once daily.

Rx only 30 Tablets

CSPC Ouyi Pharmaceutical Co., Ltd.

1.5mgbottlelabel30
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 3 mg Tablet Bottle Label

NDC 27808-223-01

Paliperidone
Extended-Release Tablets

3mg

Tablets should be swallowed whole.
Do not divide, crush, or chew.
Paliperidone should be taken once daily.

Rx only 30 Tablets

CSPC Ouyi Pharmaceutical Co., Ltd.

3mgbottlelabel30s
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 6 mg Tablet Bottle Label

NDC 27808-224-01

Paliperidone
Extended-Release Tablets

6mg

Tablets should be swallowed whole.
Do not divide, crush, or chew.
Paliperidone should be taken once daily.

Rx only 30 Tablets

CSPC Ouyi Pharmaceutical Co., Ltd.

6mgbottlelabel
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 9 mg Tablet Bottle Label

NDC 27808-225-01

Paliperidone
Extended-Release Tablets

9mg

Tablets should be swallowed whole.
Do not divide, crush, or chew.
Paliperidone should be taken once daily.

Rx only 30 Tablets

CSPC Ouyi Pharmaceutical Co., Ltd.

9mgbottlelabel30s
(click image for full-size original)
PALIPERIDONE paliperidone tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:27808-222
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
paliperidone (paliperidone) paliperidone 1.5 mg
Inactive Ingredients
Ingredient Name Strength
AMMONIA
Butylated hydroxytoluene
BUTYL ALCOHOL
cellulose acetate
Ferric oxide red
Ferric oxide yellow
Ferrosoferric oxide
HYDROXYPROPYL CELLULOSE (70000 WAMW)
HYPROMELLOSE 2910 (5 MPA.S)
ISOPROPYL ALCOHOL
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYETHYLENE OXIDE 200000
POLYETHYLENE GLYCOL 7000000
Povidone K30
Propylene glycol
Shellac
Stearic acid
Sodium chloride
Titanium dioxide
Product Characteristics
Color brown Score no score
Shape OVAL (capsule shaped) Size 10mm
Flavor Imprint Code A86
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:27808-222-01 30 TABLET, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA212807 10/29/2020
PALIPERIDONE paliperidone tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:27808-223
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
paliperidone (paliperidone) paliperidone 3 mg
Inactive Ingredients
Ingredient Name Strength
Ammonia
Butylated hydroxytoluene
BUTYL ALCOHOL
cellulose acetate
Ferric oxide red
Ferrosoferric oxide
HYDROXYPROPYL CELLULOSE (70000 WAMW)
HYPROMELLOSE 2910 (5 MPA.S)
Isopropyl alcohol
Lactose monohydrate
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYETHYLENE OXIDE 200000
POLYETHYLENE GLYCOL 7000000
Propylene glycol
Povidone K30
Shellac
Stearic acid
Sodium chloride
Titanium dioxide
Triacetin
Product Characteristics
Color white Score no score
Shape OVAL (capsule shaped) Size 10mm
Flavor Imprint Code A87
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:27808-223-01 30 TABLET, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA212807 10/29/2020
PALIPERIDONE paliperidone tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:27808-224
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
paliperidone (paliperidone) paliperidone 6 mg
Inactive Ingredients
Ingredient Name Strength
Ammonia
Butylated hydroxytoluene
Butyl alcohol
cellulose acetate
Ferric oxide red
Ferric oxide yellow
Ferrosoferric oxide
HYDROXYPROPYL CELLULOSE (70000 WAMW)
HYPROMELLOSE 2910 (5 MPA.S)
Isopropyl alcohol
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYETHYLENE OXIDE 200000
POLYETHYLENE GLYCOL 7000000
Povidone K30
Propylene glycol
Shellac
Stearic acid
Sodium chloride
Titanium dioxide
Product Characteristics
Color brown (beige) Score no score
Shape OVAL (capsule shaped) Size 10mm
Flavor Imprint Code A88
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:27808-224-01 30 TABLET, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA212807 10/29/2020
PALIPERIDONE paliperidone tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:27808-225
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
paliperidone (paliperidone) paliperidone 9 mg
Inactive Ingredients
Ingredient Name Strength
Ammonia
Butylated hydroxytoluene
Butyl alcohol
cellulose acetate
Ferric oxide red
Ferrosoferric oxide
HYDROXYPROPYL CELLULOSE (70000 WAMW)
HYPROMELLOSE 2910 (5 MPA.S)
Isopropyl alcohol
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYETHYLENE OXIDE 200000
POLYETHYLENE GLYCOL 7000000
Povidone K30
Propylene glycol
Shellac
Stearic acid
Sodium chloride
Titanium dioxide
Product Characteristics
Color pink Score no score
Shape OVAL (capsule shaped) Size 10mm
Flavor Imprint Code A89
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:27808-225-01 30 TABLET, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA212807 10/29/2020
Labeler — Tris Pharma Inc (947472119)

Revised: 06/2021 Tris Pharma Inc

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