Risperidone (Page 13 of 13)

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RISPERIDONE risperidone tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42291-909
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RISPERIDONE (RISPERIDONE) RISPERIDONE 0.5 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE
MICROCRYSTALLINE CELLULOSE 102
MAGNESIUM PALMITOSTEARATE
STARCH, CORN
HYPROMELLOSE, UNSPECIFIED
POLYETHYLENE GLYCOL, UNSPECIFIED
FERRIC OXIDE RED
TITANIUM DIOXIDE
Product Characteristics
Color brown Score no score
Shape ROUND (biconvex) Size 3mm
Flavor Imprint Code r;5
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42291-909-50 500 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078071 09/10/2021
RISPERIDONE risperidone tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42291-910
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RISPERIDONE (RISPERIDONE) RISPERIDONE 1 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE
MICROCRYSTALLINE CELLULOSE 102
MAGNESIUM PALMITOSTEARATE
STARCH, CORN
HYPROMELLOSE, UNSPECIFIED
POLYETHYLENE GLYCOL, UNSPECIFIED
Product Characteristics
Color white Score no score
Shape ROUND (biconvex) Size 3mm
Flavor Imprint Code r;1
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42291-910-50 500 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078071 09/10/2021
RISPERIDONE risperidone tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42291-911
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RISPERIDONE (RISPERIDONE) RISPERIDONE 2 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE
MICROCRYSTALLINE CELLULOSE 102
MAGNESIUM PALMITOSTEARATE
STARCH, CORN
HYPROMELLOSE, UNSPECIFIED
POLYETHYLENE GLYCOL, UNSPECIFIED
FD&C YELLOW NO. 6
TITANIUM DIOXIDE
Product Characteristics
Color orange Score no score
Shape ROUND (biconvex) Size 4mm
Flavor Imprint Code r;2
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42291-911-50 500 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078071 09/10/2021
RISPERIDONE risperidone tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42291-912
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RISPERIDONE (RISPERIDONE) RISPERIDONE 3 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE
MICROCRYSTALLINE CELLULOSE 102
MAGNESIUM PALMITOSTEARATE
STARCH, CORN
HYPROMELLOSE, UNSPECIFIED
POLYETHYLENE GLYCOL, UNSPECIFIED
FD&C YELLOW NO. 5
TITANIUM DIOXIDE
FD&C BLUE NO. 2–ALUMINUM LAKE
Product Characteristics
Color yellow Score no score
Shape ROUND (biconvex) Size 4mm
Flavor Imprint Code r;3
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42291-912-50 500 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078071 09/10/2021
RISPERIDONE risperidone tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42291-913
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RISPERIDONE (RISPERIDONE) RISPERIDONE 4 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE
MICROCRYSTALLINE CELLULOSE 102
MAGNESIUM PALMITOSTEARATE
STARCH, CORN
HYPROMELLOSE, UNSPECIFIED
POLYETHYLENE GLYCOL, UNSPECIFIED
FD&C YELLOW NO. 5
TITANIUM DIOXIDE
FD&C BLUE NO. 1 ALUMINUM LAKE
Product Characteristics
Color green Score no score
Shape ROUND (biconvex) Size 5mm
Flavor Imprint Code r;4
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42291-913-50 500 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078071 09/10/2021
RISPERIDONE risperidone tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42291-908
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RISPERIDONE (RISPERIDONE) RISPERIDONE 0.25 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE
MICROCRYSTALLINE CELLULOSE 102
MAGNESIUM PALMITOSTEARATE
STARCH, CORN
HYPROMELLOSE, UNSPECIFIED
POLYETHYLENE GLYCOL, UNSPECIFIED
D&C YELLOW NO. 10 ALUMINUM LAKE
FD&C YELLOW NO. 6
FERROSOFERRIC OXIDE
FERRIC OXIDE YELLOW
TITANIUM DIOXIDE
Product Characteristics
Color yellow Score no score
Shape ROUND (biconvex) Size 3mm
Flavor Imprint Code r
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42291-908-50 500 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078071 09/10/2021
Labeler — AvKARE (796560394)

Revised: 01/2023 AvKARE

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