Risperidone (Page 12 of 12)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

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

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

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

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

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

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

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

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

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

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.