NDC Code(s) : 62756-700-83, 62756-700-88, 62756-700-08, 62756-700-18, 62756-700-64, 62756-700-84, 62756-701-83, 62756-701-88, 62756-701-08, 62756-701-18, 62756-701-64, 62756-701-84, 62756-702-83, 62756-702-88, 62756-702-08, 62756-702-18, 62756-702-64, 62756-702-84, 62756-633-83, 62756-633-88, 62756-633-08, 62756-633-18, 62756-633-84, 62756-634-83, 62756-634-88, 62756-634-08, 62756-634-18, 62756-634-84
Packager : Sun Pharmaceutical Industries Limited

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Risperidone Risperidone TABLET, ORALLY DISINTEGRATING
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62756-700
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RISPERIDONE(UNII: L6UH7ZF8HC)
(RISPERIDONE - UNII:L6UH7ZF8HC) 		RISPERIDONE0.5 mg
Inactive Ingredients
Ingredient Name Strength
POLACRILIN(UNII: RCZ785HI7S)
POLACRILIN POTASSIUM(UNII: 0BZ5A00FQU)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
GUAR GUM(UNII: E89I1637KE)
MANNITOL(UNII: 3OWL53L36A)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
ASPARTAME(UNII: Z0H242BBR1)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE(UNII: 70097M6I30)
Product Characteristics
Color WHITE (White to off white) Score no score
Shape ROUND (circular) Size 5 mm
Flavor MINT Imprint Code 700
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:62756-700-8330 in 1 BOTTLE Type 0: Not a Combination Product13/04/2013
2NDC:62756-700-88100 in 1 BOTTLE Type 0: Not a Combination Product13/04/2013
3NDC:62756-700-08100 in 1 BOTTLE Type 0: Not a Combination Product13/04/2013
4NDC:62756-700-181000 in 1 BOTTLE Type 0: Not a Combination Product13/04/2013
5NDC:62756-700-643 in 1 CARTON 13/04/2013
510 in 1 BLISTER PACK Type 0: Not a Combination Product13/04/2013
6NDC:62756-700-8428 in 1 BOTTLE Type 0: Not a Combination Product13/04/2013
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078464 04/13/2013 01/12/2017
Risperidone Risperidone TABLET, ORALLY DISINTEGRATING
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62756-701
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RISPERIDONE(UNII: L6UH7ZF8HC)
(RISPERIDONE - UNII:L6UH7ZF8HC) 		RISPERIDONE1 mg
Inactive Ingredients
Ingredient Name Strength
POLACRILIN(UNII: RCZ785HI7S)
POLACRILIN POTASSIUM(UNII: 0BZ5A00FQU)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
GUAR GUM(UNII: E89I1637KE)
MANNITOL(UNII: 3OWL53L36A)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
ASPARTAME(UNII: Z0H242BBR1)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE(UNII: 70097M6I30)
Product Characteristics
Color WHITE (White to off white) Score no score
Shape ROUND (circular) Size 7 mm
Flavor MINT Imprint Code 701;C
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:62756-701-8330 in 1 BOTTLE Type 0: Not a Combination Product13/04/2013
2NDC:62756-701-88100 in 1 BOTTLE Type 0: Not a Combination Product13/04/2013
3NDC:62756-701-08100 in 1 BOTTLE Type 0: Not a Combination Product13/04/2013
4NDC:62756-701-181000 in 1 BOTTLE Type 0: Not a Combination Product13/04/2013
5NDC:62756-701-643 in 1 CARTON 13/04/2013
510 in 1 BLISTER PACK Type 0: Not a Combination Product13/04/2013
6NDC:62756-701-8428 in 1 BOTTLE Type 0: Not a Combination Product13/04/2013
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078464 04/13/2013 01/12/2017
Risperidone Risperidone TABLET, ORALLY DISINTEGRATING
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62756-702
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RISPERIDONE(UNII: L6UH7ZF8HC)
(RISPERIDONE - UNII:L6UH7ZF8HC) 		RISPERIDONE2 mg
Inactive Ingredients
Ingredient Name Strength
POLACRILIN(UNII: RCZ785HI7S)
POLACRILIN POTASSIUM(UNII: 0BZ5A00FQU)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
GUAR GUM(UNII: E89I1637KE)
MANNITOL(UNII: 3OWL53L36A)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
ASPARTAME(UNII: Z0H242BBR1)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE(UNII: 70097M6I30)
Product Characteristics
Color WHITE (White to off white) Score no score
Shape ROUND (circular) Size 9 mm
Flavor MINT Imprint Code 702;C
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:62756-702-8330 in 1 BOTTLE Type 0: Not a Combination Product13/04/2013
2NDC:62756-702-88100 in 1 BOTTLE Type 0: Not a Combination Product13/04/2013
3NDC:62756-702-08100 in 1 BOTTLE Type 0: Not a Combination Product13/04/2013
4NDC:62756-702-181000 in 1 BOTTLE Type 0: Not a Combination Product13/04/2013
5NDC:62756-702-643 in 1 CARTON 13/04/2013
510 in 1 BLISTER PACK Type 0: Not a Combination Product13/04/2013
6NDC:62756-702-8428 in 1 BOTTLE Type 0: Not a Combination Product13/04/2013
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078464 04/13/2013 01/12/2017
Risperidone Risperidone TABLET, ORALLY DISINTEGRATING
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62756-633
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RISPERIDONE(UNII: L6UH7ZF8HC)
(RISPERIDONE - UNII:L6UH7ZF8HC) 		RISPERIDONE3 mg
Inactive Ingredients
Ingredient Name Strength
POLACRILIN(UNII: RCZ785HI7S)
POLACRILIN POTASSIUM(UNII: 0BZ5A00FQU)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
GUAR GUM(UNII: E89I1637KE)
MANNITOL(UNII: 3OWL53L36A)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
ASPARTAME(UNII: Z0H242BBR1)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE(UNII: 70097M6I30)
Product Characteristics
Color WHITE (White to off white) Score no score
Shape ROUND (circular) Size 10 mm
Flavor MINT Imprint Code 633
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:62756-633-8330 in 1 BOTTLE Type 0: Not a Combination Product13/04/2013
2NDC:62756-633-88100 in 1 BOTTLE Type 0: Not a Combination Product13/04/2013
3NDC:62756-633-08100 in 1 BOTTLE Type 0: Not a Combination Product13/04/2013
4NDC:62756-633-181000 in 1 BOTTLE Type 0: Not a Combination Product13/04/2013
5NDC:62756-633-8428 in 1 BOTTLE Type 0: Not a Combination Product13/04/2013
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078464 04/13/2013 01/12/2017
Risperidone Risperidone TABLET, ORALLY DISINTEGRATING
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62756-634
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RISPERIDONE(UNII: L6UH7ZF8HC)
(RISPERIDONE - UNII:L6UH7ZF8HC) 		RISPERIDONE4 mg
Inactive Ingredients
Ingredient Name Strength
POLACRILIN(UNII: RCZ785HI7S)
POLACRILIN POTASSIUM(UNII: 0BZ5A00FQU)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
GUAR GUM(UNII: E89I1637KE)
MANNITOL(UNII: 3OWL53L36A)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
ASPARTAME(UNII: Z0H242BBR1)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE(UNII: 70097M6I30)
Product Characteristics
Color WHITE (White to off white) Score no score
Shape ROUND (circular) Size 10 mm
Flavor MINT Imprint Code 634
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:62756-634-8330 in 1 BOTTLE Type 0: Not a Combination Product13/04/2013
2NDC:62756-634-88100 in 1 BOTTLE Type 0: Not a Combination Product13/04/2013
3NDC:62756-634-08100 in 1 BOTTLE Type 0: Not a Combination Product13/04/2013
4NDC:62756-634-181000 in 1 BOTTLE Type 0: Not a Combination Product13/04/2013
5NDC:62756-634-8428 in 1 BOTTLE Type 0: Not a Combination Product13/04/2013
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078464 04/13/2013 01/12/2017

PRINCIPAL DISPLAY PANEL


NDC 62756-700-84
risperiDONE Orally Disintegrating Tablets, USP
0.5 mg
Rx only
28 Tablets
SUN PHARMA


risperidone-label-05mg

PRINCIPAL DISPLAY PANEL


NDC 62756-701-84
risperiDONE Orally Disintegrating Tablets, USP
1 mg
Rx only
28 Tablets
SUN PHARMA


risperidone-label-1mg

PRINCIPAL DISPLAY PANEL


NDC 62756-702-84
risperiDONE Orally Disintegrating Tablets, USP
2 mg
Rx only
28 Tablets
SUN PHARMA


risperidone-label-2mg

PRINCIPAL DISPLAY PANEL


NDC 62756-633-84
risperiDONE Orally Disintegrating Tablets, USP
3 mg
Rx only
28 Tablets
SUN PHARMA


risperidone-label-3mg

PRINCIPAL DISPLAY PANEL


NDC 62756-634-84
risperiDONE Orally Disintegrating Tablets, USP
4 mg
Rx only
28 Tablets
SUN PHARMA


risperidone-label-4mg