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 August 12, 2024

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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)

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Published Date (What is this?)	Version	Files
Aug 15, 2024	9 (current)	download
Nov 2, 2022	8	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

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	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

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Drug Label Info

Safety

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More Info For This Drug

Drug Label Information

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More Info on this Drug

RISPERIDONE tablet, film coated

Number of versions: 9

RISPERIDONE tablet, film coated

RISPERIDONE tablet, film coated

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RISPERIDONE tablet, film coated

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