DailyMed - RISPERIDONE tablet, film coated

NDC Code(s): 65841-665-01, 65841-665-05, 65841-665-06, 65841-665-10, view more
65841-665-14, 65841-665-16, 65841-666-01, 65841-666-05, 65841-666-06, 65841-666-10, 65841-666-14, 65841-666-16, 65841-667-01, 65841-667-05, 65841-667-06, 65841-667-10, 65841-667-14, 65841-667-16, 65841-668-01, 65841-668-05, 65841-668-06, 65841-668-10, 65841-668-14, 65841-668-16, 65841-669-01, 65841-669-05, 65841-669-06, 65841-669-10, 65841-669-14, 65841-669-16, 65841-670-01, 65841-670-05, 65841-670-06, 65841-670-10, 65841-670-14, 65841-670-16
Packager: Zydus Lifesciences Limited

Category: HUMAN PRESCRIPTION DRUG LABEL
DEA Schedule: None
Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated October 31, 2022

If you are a consumer or patient please visit this version.

Download DRUG LABEL INFO: PDF XML
Official Label (Printer Friendly)

View All Sections

SPL UNCLASSIFIED SECTION
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Risperidone Tablets USP, 0.25 mg

NDC 65841-665-14

60 tablets

Rx only

Risperidone Tablets USP, 0.5 mg

NDC 65841-666-14

60 tablets

Rx only

Risperidone Tablets USP, 1 mg

NDC 65841-667-14

60 Tablets

Rx only

Risperidone Tablets USP, 2 mg

NDC 65841-668-14

60 Tablets

Rx only

Risperidone Tablets USP, 3 mg

NDC 65841-669-14

60 Tablets

Rx only

Risperidone Tablets USP, 4 mg

NDC 65841-670-14

60 Tablets

Rx only

INGREDIENTS AND APPEARANCE

RISPERIDONE
risperidone tablet, film coated

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:65841-665
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
RISPERIDONE (UNII: L6UH7ZF8HC) (RISPERIDONE - UNII:L6UH7ZF8HC)	RISPERIDONE	0.25 mg

Ingredient Name	Strength
Inactive Ingredients
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
Color	YELLOW (DARK YELLOW)	Score	no score
Shape	ROUND (ROUND)	Size	5mm
Flavor		Imprint Code	Z;4
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:65841-665-06	30 in 1 BOTTLE; Type 0: Not a Combination Product	11/13/2008
2	NDC:65841-665-14	60 in 1 BOTTLE; Type 0: Not a Combination Product	11/13/2008
3	NDC:65841-665-16	90 in 1 BOTTLE; Type 0: Not a Combination Product	11/13/2008
4	NDC:65841-665-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	11/13/2008
5	NDC:65841-665-05	500 in 1 BOTTLE; Type 0: Not a Combination Product	11/13/2008
6	NDC:65841-665-10	1000 in 1 BOTTLE; Type 0: Not a Combination Product	11/13/2008

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA078040	11/13/2008

RISPERIDONE
risperidone tablet, film coated

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:65841-666
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
RISPERIDONE (UNII: L6UH7ZF8HC) (RISPERIDONE - UNII:L6UH7ZF8HC)	RISPERIDONE	0.5 mg

Ingredient Name	Strength
Inactive Ingredients
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
Color	RED (RED BROWN)	Score	no score
Shape	ROUND (ROUND)	Size	5mm
Flavor		Imprint Code	Z;6
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:65841-666-06	30 in 1 BOTTLE; Type 0: Not a Combination Product	11/13/2008
2	NDC:65841-666-14	60 in 1 BOTTLE; Type 0: Not a Combination Product	11/13/2008
3	NDC:65841-666-16	90 in 1 BOTTLE; Type 0: Not a Combination Product	11/13/2008
4	NDC:65841-666-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	11/13/2008
5	NDC:65841-666-05	500 in 1 BOTTLE; Type 0: Not a Combination Product	11/13/2008
6	NDC:65841-666-10	1000 in 1 BOTTLE; Type 0: Not a Combination Product	11/13/2008

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA078040	11/13/2008

RISPERIDONE
risperidone tablet, film coated

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:65841-667
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
RISPERIDONE (UNII: L6UH7ZF8HC) (RISPERIDONE - UNII:L6UH7ZF8HC)	RISPERIDONE	1 mg

Ingredient Name	Strength
Inactive Ingredients
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
Color	WHITE (WHITE TO OFF-WHITE)	Score	no score
Shape	ROUND (ROUND)	Size	6mm
Flavor		Imprint Code	ZC;75
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:65841-667-06	30 in 1 BOTTLE; Type 0: Not a Combination Product	11/13/2008
2	NDC:65841-667-14	60 in 1 BOTTLE; Type 0: Not a Combination Product	11/13/2008
3	NDC:65841-667-16	90 in 1 BOTTLE; Type 0: Not a Combination Product	11/13/2008
4	NDC:65841-667-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	11/13/2008
5	NDC:65841-667-05	500 in 1 BOTTLE; Type 0: Not a Combination Product	11/13/2008
6	NDC:65841-667-10	1000 in 1 BOTTLE; Type 0: Not a Combination Product	11/13/2008

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA078040	11/13/2008

RISPERIDONE
risperidone tablet, film coated

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:65841-668
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
RISPERIDONE (UNII: L6UH7ZF8HC) (RISPERIDONE - UNII:L6UH7ZF8HC)	RISPERIDONE	2 mg

Ingredient Name	Strength
Inactive Ingredients
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
Color	ORANGE (ORANGE)	Score	no score
Shape	ROUND (ROUND)	Size	8mm
Flavor		Imprint Code	ZC;76
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:65841-668-06	30 in 1 BOTTLE; Type 0: Not a Combination Product	11/13/2008
2	NDC:65841-668-14	60 in 1 BOTTLE; Type 0: Not a Combination Product	11/13/2008
3	NDC:65841-668-16	90 in 1 BOTTLE; Type 0: Not a Combination Product	11/13/2008
4	NDC:65841-668-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	11/13/2008
5	NDC:65841-668-05	500 in 1 BOTTLE; Type 0: Not a Combination Product	11/13/2008
6	NDC:65841-668-10	1000 in 1 BOTTLE; Type 0: Not a Combination Product	11/13/2008

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA078040	11/13/2008

RISPERIDONE
risperidone tablet, film coated

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:65841-669
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
RISPERIDONE (UNII: L6UH7ZF8HC) (RISPERIDONE - UNII:L6UH7ZF8HC)	RISPERIDONE	3 mg

Ingredient Name	Strength
Inactive Ingredients
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
Color	YELLOW (YELLOW)	Score	no score
Shape	ROUND (ROUND)	Size	10mm
Flavor		Imprint Code	ZC;77
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:65841-669-06	30 in 1 BOTTLE; Type 0: Not a Combination Product	11/13/2008
2	NDC:65841-669-14	60 in 1 BOTTLE; Type 0: Not a Combination Product	11/13/2008
3	NDC:65841-669-16	90 in 1 BOTTLE; Type 0: Not a Combination Product	11/13/2008
4	NDC:65841-669-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	11/13/2008
5	NDC:65841-669-05	500 in 1 BOTTLE; Type 0: Not a Combination Product	11/13/2008
6	NDC:65841-669-10	1000 in 1 BOTTLE; Type 0: Not a Combination Product	11/13/2008

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA078040	11/12/2008

RISPERIDONE
risperidone tablet, film coated

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:65841-670
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
RISPERIDONE (UNII: L6UH7ZF8HC) (RISPERIDONE - UNII:L6UH7ZF8HC)	RISPERIDONE	4 mg

Ingredient Name	Strength
Inactive Ingredients
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
Color	GREEN (GREEN)	Score	no score
Shape	ROUND (ROUND)	Size	11mm
Flavor		Imprint Code	ZC;78
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:65841-670-06	30 in 1 BOTTLE; Type 0: Not a Combination Product	11/13/2008
2	NDC:65841-670-14	60 in 1 BOTTLE; Type 0: Not a Combination Product	11/13/2008
3	NDC:65841-670-16	90 in 1 BOTTLE; Type 0: Not a Combination Product	11/13/2008
4	NDC:65841-670-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	11/13/2008
5	NDC:65841-670-05	500 in 1 BOTTLE; Type 0: Not a Combination Product	11/13/2008
6	NDC:65841-670-10	1000 in 1 BOTTLE; Type 0: Not a Combination Product	11/13/2008

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA078040	11/13/2008

Labeler - Zydus Lifesciences Limited (918596198)

Registrant - Zydus Lifesciences Limited (918596198)

Name	Address	ID/FEI	Business Operations
Establishment
Zydus Lifesciences Limited		918596198	ANALYSIS(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)

View All Sections

Published Date (What is this?)	Version	Files
Nov 2, 2022	8 (current)	download
Sep 21, 2020	7	download
Feb 15, 2019	6	download
Aug 22, 2018	5	download
Nov 30, 2017	4	download
Feb 2, 2012	3	download
Jul 21, 2011	2	download
Jun 21, 2011	1	download

	RxCUI	RxNorm NAME	RxTTY
1	312828	risperiDONE 0.25 MG Oral Tablet	PSN
2	312828	risperidone 0.25 MG Oral Tablet	SCD
3	312829	risperiDONE 0.5 MG Oral Tablet	PSN
4	312829	risperidone 0.5 MG Oral Tablet	SCD
5	312830	risperiDONE 1 MG Oral Tablet	PSN
6	312830	risperidone 1 MG Oral Tablet	SCD
7	312831	risperiDONE 2 MG Oral Tablet	PSN
8	312831	risperidone 2 MG Oral Tablet	SCD
9	312832	risperiDONE 3 MG Oral Tablet	PSN
10	312832	risperidone 3 MG Oral Tablet	SCD
11	314211	risperiDONE 4 MG Oral Tablet	PSN
12	314211	risperidone 4 MG Oral Tablet	SCD

Label: RISPERIDONE tablet, film coated

View Package Photos

VIEW MORE

Drug Label Info

Safety

Related Resources

More Info For This Drug

Drug Label Information

Find additional resources

Safety

Related Resources

More Info on this Drug

	NDC
1	65841-665-01
2	65841-665-05
3	65841-665-06
4	65841-665-10
5	65841-665-14
6	65841-665-16
7	65841-666-01
8	65841-666-05
9	65841-666-06
10	65841-666-10
11	65841-666-14
12	65841-666-16
13	65841-667-01
14	65841-667-05
15	65841-667-06
16	65841-667-10
17	65841-667-14
18	65841-667-16
19	65841-668-01
20	65841-668-05
21	65841-668-06
22	65841-668-10
23	65841-668-14
24	65841-668-16
25	65841-669-01
26	65841-669-05
27	65841-669-06
28	65841-669-10
29	65841-669-14
30	65841-669-16
31	65841-670-01
32	65841-670-05
33	65841-670-06
34	65841-670-10
35	65841-670-14
36	65841-670-16

Label: RISPERIDONE tablet, film coated

View Package Photos

VIEW MORE

Drug Label Info

Safety

Related Resources

More Info For This Drug

Drug Label Information

Find additional resources

Safety

Related Resources

More Info on this Drug

RISPERIDONE tablet, film coated

Number of versions: 8

RISPERIDONE tablet, film coated

RISPERIDONE tablet, film coated

To receive this label RSS feed

To receive all DailyMed Updates for the last seven days

What will I get with the DailyMed RSS feed?

How to discontinue the RSS feed

Why is DailyMed no longer displaying pill images on the Search Results and Drug Info pages?

RISPERIDONE tablet, film coated

If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.