Risperidone (Page 12 of 12)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 59746-010-32
CADISTATM
risperiDONE
Orally Disintegrating Tablets, USP
0.5 mg
30 Tablets Rx Only
(3 blister cards each containing 10 tablets)

carton01
(click image for full-size original)

risperiDONE
Orally Disintegrating Tablet, USP
0.5 mg Rx Only
Jubilant Cadista Pharmaceuticals Inc.
59746-010-32Made in India

0.5 mg foil
(click image for full-size original)

NDC 59746-020-22
CADISTATM
risperiDONE
Orally Disintegrating Tablets, USP
1 mg
28 Tablets Rx Only
(7 blister cards each containing 4 tablets)

carton02
(click image for full-size original)

risperiDONE
Orally Disintegrating Tablet, USP
1 mg Rx Only
Jubilant Cadista Pharmaceuticals Inc.
59746-020-22Made in India

1mg foil
(click image for full-size original)

NDC 59746-030-22
CADISTATM
risperiDONE
Orally Disintegrating Tablets, USP
2 mg
28 Tablets Rx Only
(7 blister cards each containing 4 tablets)

carton03
(click image for full-size original)

risperiDONE
Orally Disintegrating Tablet, USP
2 mg Rx Only
Jubilant Cadista Pharmaceuticals Inc.
59746-030-22Made in India

2mg foil
(click image for full-size original)

NDC 59746-040-22
CADISTATM
risperiDONE
Orally Disintegrating Tablets, USP
3 mg
28 Tablets Rx Only
(7 blister cards each containing 4 tablets)

carton004
(click image for full-size original)

risperiDONE
Orally Disintegrating Tablet, USP
3 mg Rx Only
Jubilant Cadista Pharmaceuticals Inc.
59746-040-22Made in India

3mg foil
(click image for full-size original)

NDC 59746-050-22 CADISTA TM
risperiDONE
Orally Disintegrating Tablets, USP
4 mg
28 Tablets Rx Only
(7 blister cards each containing 4 tablets)

carton05
(click image for full-size original)

risperiDONE
Orally Disintegrating Tablet, USP
4 mg Rx Only
Jubilant Cadista Pharmaceuticals Inc.
59746-050-22Made in India

4mg foil
(click image for full-size original)
RISPERIDONE risperidone tablet, orally disintegrating
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59746-010
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
Magnesium Aluminometasilicate Type I-a
Aspartame
Silicon Dioxide
Hydroxypropyl Cellulose, Low Substituted
Sodium Stearyl Fumarate
Dimethylaminoethyl Methacrylate — Butyl Methacrylate — Methyl Methacrylate Copolymer
Talc
Sodium Lauryl Sulfate
Acesulfame Potassium
Mannitol
Sodium Chloride
Peppermint
Ferric Oxide Yellow
Product Characteristics
Color YELLOW Score no score
Shape ROUND (Flat faced beveled edged) Size 7mm
Flavor PEPPERMINT Imprint Code C;01
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59746-010-22 7 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 4 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK This package is contained within the CARTON (59746-010-22)
2 NDC:59746-010-32 3 BLISTER PACK in 1 CARTON contains a BLISTER PACK
2 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK This package is contained within the CARTON (59746-010-32)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090839 11/04/2011
RISPERIDONE risperidone tablet, orally disintegrating
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59746-020
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
Magnesium Aluminometasilicate Type I-a
Aspartame
Silicon Dioxide
Hydroxypropyl Cellulose, Low Substituted
Sodium Stearyl Fumarate
Dimethylaminoethyl Methacrylate — Butyl Methacrylate — Methyl Methacrylate Copolymer
Talc
Sodium Lauryl Sulfate
Acesulfame Potassium
Mannitol
Sodium Chloride
Peppermint
Product Characteristics
Color WHITE Score no score
Shape ROUND (Flat faced beveled edged) Size 7mm
Flavor PEPPERMINT Imprint Code C;02
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59746-020-22 7 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 4 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK This package is contained within the CARTON (59746-020-22)
2 NDC:59746-020-32 3 BLISTER PACK in 1 CARTON contains a BLISTER PACK
2 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK This package is contained within the CARTON (59746-020-32)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090839 11/04/2011
RISPERIDONE risperidone tablet, orally disintegrating
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59746-030
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
Magnesium Aluminometasilicate Type I-a
Aspartame
Silicon Dioxide
Hydroxypropyl Cellulose, Low Substituted
Sodium Stearyl Fumarate
Dimethylaminoethyl Methacrylate — Butyl Methacrylate — Methyl Methacrylate Copolymer
Talc
Sodium Lauryl Sulfate
Acesulfame Potassium
Mannitol
Sodium Chloride
Peppermint
Fd&c Blue No. 1
Product Characteristics
Color BLUE Score no score
Shape ROUND (Flat faced beveled edged) Size 7mm
Flavor PEPPERMINT Imprint Code C;03
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59746-030-22 7 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 4 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK This package is contained within the CARTON (59746-030-22)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090839 11/04/2011
RISPERIDONE risperidone tablet, orally disintegrating
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59746-040
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
Magnesium Aluminometasilicate Type I-a
Aspartame
Silicon Dioxide
Hydroxypropyl Cellulose, Low Substituted
Sodium Stearyl Fumarate
Dimethylaminoethyl Methacrylate — Butyl Methacrylate — Methyl Methacrylate Copolymer
Talc
Sodium Lauryl Sulfate
Acesulfame Potassium
Mannitol
Sodium Chloride
Peppermint
Fd&c Yellow No. 6
Product Characteristics
Color ORANGE Score no score
Shape ROUND (Flat faced beveled edged) Size 7mm
Flavor PEPPERMINT Imprint Code C;04
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59746-040-22 7 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 4 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK This package is contained within the CARTON (59746-040-22)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090839 11/04/2011
RISPERIDONE risperidone tablet, orally disintegrating
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59746-050
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
Magnesium Aluminometasilicate Type I-a
Aspartame
Silicon Dioxide
Hydroxypropyl Cellulose, Low Substituted
Sodium Stearyl Fumarate
Dimethylaminoethyl Methacrylate — Butyl Methacrylate — Methyl Methacrylate Copolymer
Talc
Sodium Lauryl Sulfate
Acesulfame Potassium
Mannitol
Sodium Chloride
Peppermint
Ferric Oxide Red
Product Characteristics
Color PINK Score no score
Shape ROUND (Flat faced beveled edged) Size 7mm
Flavor PEPPERMINT Imprint Code C;05
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59746-050-22 7 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 4 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK This package is contained within the CARTON (59746-050-22)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090839 11/04/2011
Labeler — Jubilant Cadista Pharmaceuticals Inc. (022490515)
Registrant — Jubilant Generics Limited (650801538)
Establishment
Name Address ID/FEI Operations
Jubilant Generics Limited 650369221 MANUFACTURE (59746-010), MANUFACTURE (59746-020), MANUFACTURE (59746-030), MANUFACTURE (59746-040), MANUFACTURE (59746-050)

Revised: 02/2023 Jubilant Cadista Pharmaceuticals Inc.

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