RISPERIDONE - risperidone tablet, orally disintegrating 
Zydus Lifesciences Limited

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RISPERIDONE ORALLY DISINTEGRATING TABLETS

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 65841-640-06 in bottle of 30 tablets

Risperidone Orally Disintegrating Tablets, 0.5 mg

Rx only

30 tablets

Risperidone Orally Disintegrating Tablets

NDC 65841-641-06 in bottle of 30 tablets

Risperidone Orally Disintegrating Tablets, 1 mg

Rx only

30 tablets

Risperidone Orally Disintegrating Tablets

NDC 65841-642-06 in bottle of 30 tablets

Risperidone Orally Disintegrating Tablets, 2 mg

Rx only

30 tablets

Risperidone Orally Disintegrating Tablets
RISPERIDONE 
risperidone tablet, orally disintegrating
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-640
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
RISPERIDONE (UNII: L6UH7ZF8HC) (RISPERIDONE - UNII:L6UH7ZF8HC) RISPERIDONE0.5 mg
Inactive Ingredients
Ingredient NameStrength
ASPARTAME (UNII: Z0H242BBR1)  
CALCIUM STEARATE (UNII: 776XM7047L)  
CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)  
MANNITOL (UNII: 3OWL53L36A)  
PEPPERMINT (UNII: V95R5KMY2B)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER (UNII: 905HNO1SIH)  
Product Characteristics
ColorWHITE (WHITE TO OFF-WHITE) Scoreno score
ShapeROUND (ROUND) Size6mm
FlavorPEPPERMINT (FLAVOR FIRMENICH POWDER PEPPERMINT) Imprint Code ZD;22
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65841-640-0630 in 1 BOTTLE; Type 0: Not a Combination Product06/29/2010
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07851606/29/2010
RISPERIDONE 
risperidone tablet, orally disintegrating
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-641
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
RISPERIDONE (UNII: L6UH7ZF8HC) (RISPERIDONE - UNII:L6UH7ZF8HC) RISPERIDONE1 mg
Inactive Ingredients
Ingredient NameStrength
ASPARTAME (UNII: Z0H242BBR1)  
CALCIUM STEARATE (UNII: 776XM7047L)  
CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)  
MANNITOL (UNII: 3OWL53L36A)  
PEPPERMINT (UNII: V95R5KMY2B)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER (UNII: 905HNO1SIH)  
Product Characteristics
ColorWHITE (WHITE TO OFF-WHITE) Scoreno score
ShapeROUND (ROUND) Size8mm
FlavorPEPPERMINT (FLAVOR FIRMENICH POWDER PEPPERMINT) Imprint Code ZD;21
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65841-641-0630 in 1 BOTTLE; Type 0: Not a Combination Product06/29/2010
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07851606/29/2010
RISPERIDONE 
risperidone tablet, orally disintegrating
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-642
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
RISPERIDONE (UNII: L6UH7ZF8HC) (RISPERIDONE - UNII:L6UH7ZF8HC) RISPERIDONE2 mg
Inactive Ingredients
Ingredient NameStrength
ASPARTAME (UNII: Z0H242BBR1)  
CALCIUM STEARATE (UNII: 776XM7047L)  
CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)  
MANNITOL (UNII: 3OWL53L36A)  
PEPPERMINT (UNII: V95R5KMY2B)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER (UNII: 905HNO1SIH)  
Product Characteristics
ColorWHITE (WHITE TO OFF-WHITE) Scoreno score
ShapeROUND (ROUND) Size10mm
FlavorPEPPERMINT (FLAVOR FIRMENICH POWDER PEPPERMINT) Imprint Code ZD;20
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65841-642-0630 in 1 BOTTLE; Type 0: Not a Combination Product06/29/2010
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07851606/29/2010
Labeler - Zydus Lifesciences Limited (918596198)
Registrant - Zydus Lifesciences Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Zydus Lifesciences Limited918596198ANALYSIS(65841-640, 65841-641, 65841-642) , MANUFACTURE(65841-640, 65841-641, 65841-642)

Revised: 10/2022
Document Id: 43c2c43f-bcf8-446f-befe-fd01d1916f48
Set id: 1522f0b9-2bbc-4785-bada-fa6ae7986bb4
Version: 10
Effective Time: 20221014
 
Zydus Lifesciences Limited