RISPERIDONE- risperidone tablet, film coated 
Cadila Healthcare Limited

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RISPERIDONE TABLETS

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Risperidone Tablets USP, 0.25 mg

NDC 65841-665-14

60 tablets

Rx only

image

Risperidone Tablets USP, 0.5 mg

NDC 65841-666-14

60 tablets

Rx only

image

Risperidone Tablets USP, 1 mg

NDC 65841-667-14

60 Tablets

Rx only

image

Risperidone Tablets USP, 2 mg

NDC 65841-668-14

60 Tablets

Rx only

image

Risperidone Tablets USP, 3 mg

NDC 65841-669-14

60 Tablets

Rx only

image

Risperidone Tablets USP, 4 mg

NDC 65841-670-14

60 Tablets

Rx only

image
RISPERIDONE 
risperidone tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-665
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
RISPERIDONE (UNII: L6UH7ZF8HC) (RISPERIDONE - UNII:L6UH7ZF8HC) RISPERIDONE0.25 mg
Inactive Ingredients
Ingredient NameStrength
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
STARCH, CORN (UNII: O8232NY3SJ)  
Product Characteristics
ColorYELLOW (DARK YELLOW) Scoreno score
ShapeROUND (ROUND) Size5mm
FlavorImprint Code Z;4
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65841-665-0630 in 1 BOTTLE; Type 0: Not a Combination Product11/13/2008
2NDC:65841-665-1460 in 1 BOTTLE; Type 0: Not a Combination Product11/13/2008
3NDC:65841-665-1690 in 1 BOTTLE; Type 0: Not a Combination Product11/13/2008
4NDC:65841-665-01100 in 1 BOTTLE; Type 0: Not a Combination Product11/13/2008
5NDC:65841-665-05500 in 1 BOTTLE; Type 0: Not a Combination Product11/13/2008
6NDC:65841-665-101000 in 1 BOTTLE; Type 0: Not a Combination Product11/13/2008
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07804011/13/2008
RISPERIDONE 
risperidone tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-666
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
RISPERIDONE (UNII: L6UH7ZF8HC) (RISPERIDONE - UNII:L6UH7ZF8HC) RISPERIDONE0.5 mg
Inactive Ingredients
Ingredient NameStrength
HYPROMELLOSES (UNII: 3NXW29V3WO)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
STARCH, CORN (UNII: O8232NY3SJ)  
Product Characteristics
ColorRED (RED BROWN) Scoreno score
ShapeROUND (ROUND) Size5mm
FlavorImprint Code Z;6
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65841-666-0630 in 1 BOTTLE; Type 0: Not a Combination Product11/13/2008
2NDC:65841-666-1460 in 1 BOTTLE; Type 0: Not a Combination Product11/13/2008
3NDC:65841-666-1690 in 1 BOTTLE; Type 0: Not a Combination Product11/13/2008
4NDC:65841-666-01100 in 1 BOTTLE; Type 0: Not a Combination Product11/13/2008
5NDC:65841-666-05500 in 1 BOTTLE; Type 0: Not a Combination Product11/13/2008
6NDC:65841-666-101000 in 1 BOTTLE; Type 0: Not a Combination Product11/13/2008
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07804011/13/2008
RISPERIDONE 
risperidone tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-667
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
RISPERIDONE (UNII: L6UH7ZF8HC) (RISPERIDONE - UNII:L6UH7ZF8HC) RISPERIDONE1 mg
Inactive Ingredients
Ingredient NameStrength
HYPROMELLOSES (UNII: 3NXW29V3WO)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
STARCH, CORN (UNII: O8232NY3SJ)  
Product Characteristics
ColorWHITE (WHITE TO OFF-WHITE) Scoreno score
ShapeROUND (ROUND) Size6mm
FlavorImprint Code ZC;75
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65841-667-0630 in 1 BOTTLE; Type 0: Not a Combination Product11/13/2008
2NDC:65841-667-1460 in 1 BOTTLE; Type 0: Not a Combination Product11/13/2008
3NDC:65841-667-1690 in 1 BOTTLE; Type 0: Not a Combination Product11/13/2008
4NDC:65841-667-01100 in 1 BOTTLE; Type 0: Not a Combination Product11/13/2008
5NDC:65841-667-05500 in 1 BOTTLE; Type 0: Not a Combination Product11/13/2008
6NDC:65841-667-101000 in 1 BOTTLE; Type 0: Not a Combination Product11/13/2008
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07804011/13/2008
RISPERIDONE 
risperidone tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-668
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
RISPERIDONE (UNII: L6UH7ZF8HC) (RISPERIDONE - UNII:L6UH7ZF8HC) RISPERIDONE2 mg
Inactive Ingredients
Ingredient NameStrength
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
STARCH, CORN (UNII: O8232NY3SJ)  
Product Characteristics
ColorORANGE (ORANGE) Scoreno score
ShapeROUND (ROUND) Size8mm
FlavorImprint Code ZC;76
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65841-668-0630 in 1 BOTTLE; Type 0: Not a Combination Product11/13/2008
2NDC:65841-668-1460 in 1 BOTTLE; Type 0: Not a Combination Product11/13/2008
3NDC:65841-668-1690 in 1 BOTTLE; Type 0: Not a Combination Product11/13/2008
4NDC:65841-668-01100 in 1 BOTTLE; Type 0: Not a Combination Product11/13/2008
5NDC:65841-668-05500 in 1 BOTTLE; Type 0: Not a Combination Product11/13/2008
6NDC:65841-668-101000 in 1 BOTTLE; Type 0: Not a Combination Product11/13/2008
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07804011/13/2008
RISPERIDONE 
risperidone tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-669
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
RISPERIDONE (UNII: L6UH7ZF8HC) (RISPERIDONE - UNII:L6UH7ZF8HC) RISPERIDONE3 mg
Inactive Ingredients
Ingredient NameStrength
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
STARCH, CORN (UNII: O8232NY3SJ)  
Product Characteristics
ColorYELLOW (YELLOW) Scoreno score
ShapeROUND (ROUND) Size10mm
FlavorImprint Code ZC;77
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65841-669-0630 in 1 BOTTLE; Type 0: Not a Combination Product11/13/2008
2NDC:65841-669-1460 in 1 BOTTLE; Type 0: Not a Combination Product11/13/2008
3NDC:65841-669-1690 in 1 BOTTLE; Type 0: Not a Combination Product11/13/2008
4NDC:65841-669-01100 in 1 BOTTLE; Type 0: Not a Combination Product11/13/2008
5NDC:65841-669-05500 in 1 BOTTLE; Type 0: Not a Combination Product11/13/2008
6NDC:65841-669-101000 in 1 BOTTLE; Type 0: Not a Combination Product11/13/2008
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07804011/12/2008
RISPERIDONE 
risperidone tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-670
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
RISPERIDONE (UNII: L6UH7ZF8HC) (RISPERIDONE - UNII:L6UH7ZF8HC) RISPERIDONE4 mg
Inactive Ingredients
Ingredient NameStrength
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
STARCH, CORN (UNII: O8232NY3SJ)  
Product Characteristics
ColorGREEN (GREEN) Scoreno score
ShapeROUND (ROUND) Size11mm
FlavorImprint Code ZC;78
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65841-670-0630 in 1 BOTTLE; Type 0: Not a Combination Product11/13/2008
2NDC:65841-670-1460 in 1 BOTTLE; Type 0: Not a Combination Product11/13/2008
3NDC:65841-670-1690 in 1 BOTTLE; Type 0: Not a Combination Product11/13/2008
4NDC:65841-670-01100 in 1 BOTTLE; Type 0: Not a Combination Product11/13/2008
5NDC:65841-670-05500 in 1 BOTTLE; Type 0: Not a Combination Product11/13/2008
6NDC:65841-670-101000 in 1 BOTTLE; Type 0: Not a Combination Product11/13/2008
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07804011/13/2008
Labeler - Cadila Healthcare Limited (918596198)
Registrant - Cadila Healthcare Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Cadila Healthcare Limited918596198ANALYSIS(65841-665, 65841-666, 65841-667, 65841-668, 65841-669, 65841-670) , MANUFACTURE(65841-665, 65841-666, 65841-667, 65841-668, 65841-669, 65841-670)

Revised: 9/2020
Document Id: d232768d-ac46-42c7-b9d7-d9f695141599
Set id: 23993d21-80bf-41c4-b57d-88a620173b6b
Version: 7
Effective Time: 20200914
 
Cadila Healthcare Limited