risperidone

Product NDC: 68382-113
11-digit product format: 683820113
Labeler code: 68382
Product ID: 68382-113_2af53e64-46a6-4b12-9ac8-8f8031a8bd97
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: risperidone
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Zydus Pharmaceuticals USA Inc.
Application: ANDA078040
Marketing category: ANDA
Marketing start: 2008-11-13
Substance: RISPERIDONE
Active strength: .5 mg/1
Pharmacologic classes: Atypical Antipsychotic [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Additional Listing Data#

Finished product: Yes
Brand name base: risperidone
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
RISPERIDONE	.5 mg/1

Harmonized Identifiers#

Field, Values table
Field	Values
Unii	L6UH7ZF8HC
Rxcui	312828, 312829, 312830, 312831, 312832, 314211

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6ab2126a-0ca2-c16c-ab6d-b3a031ba7ac6	Product name	5	20250303
0efa9fd6-2fb6-4cd3-8b0f-2a2bf9c4a09e	Product name	1	20250128
e457a910-2c3a-4bfd-90b9-0310982c50dd	Product name	1	20241218
42b1a2d5-888a-4386-ab9f-0979e0d7b4aa	Product name	1	20231010
66685e90-862d-4873-a0c5-2be73b803c36	Product name	1	20230921
92d220a1-2a4c-4393-9080-7335ca8223cc	Product name	1	20230823
351abe41-466c-4dd8-840a-0fdb68318bd5	Product name	1	20230316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
68382-113-01	risperidone	100 in 1 BOTTLE	TABLET, FILM COATED	100	25
68382-113-05	risperidone	500 in 1 BOTTLE	TABLET, FILM COATED	500	25
68382-113-06	risperidone	30 in 1 BOTTLE	TABLET, FILM COATED	30	25
68382-113-10	risperidone	1000 in 1 BOTTLE	TABLET, FILM COATED	1000	25
68382-113-14	risperidone	60 in 1 BOTTLE	TABLET, FILM COATED	60	25
68382-113-16	risperidone	90 in 1 BOTTLE	TABLET, FILM COATED	90	25

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68382-113-05	EA - Each	68382-113	8ff7fd11-e7c8-40bf-bd9e-5ef5d10e4e83	1	2012-07-24
68382-113-14	EA - Each	68382-113	04268c91-ebaa-4569-9f2c-f0e5bb566ea1	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
RISPERIDONE	ACTIVE INGREDIENT	L6UH7ZF8HC	RISPERIDONE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]	13
RISPERIDONE	ACTIVE MOIETY	L6UH7ZF8HC	RISPERIDONE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]	13
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	RISPERIDONE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]	13
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	RISPERIDONE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]	13
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	RISPERIDONE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]	13
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	RISPERIDONE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]	13
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	RISPERIDONE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]	13
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	RISPERIDONE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]	13
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	RISPERIDONE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]	13
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	RISPERIDONE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]	13
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	RISPERIDONE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]	13
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	RISPERIDONE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]	13
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	RISPERIDONE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]	13
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	RISPERIDONE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]	13
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	RISPERIDONE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]	13
RISPERIDONE	ACTIVE INGREDIENT	L6UH7ZF8HC	RISPERIDONE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	7
RISPERIDONE	ACTIVE MOIETY	L6UH7ZF8HC	RISPERIDONE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	7
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	RISPERIDONE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	7
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	RISPERIDONE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	7
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	RISPERIDONE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	7
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	RISPERIDONE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	7
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	RISPERIDONE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	7
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	RISPERIDONE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	7
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	RISPERIDONE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	7
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	RISPERIDONE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	7
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	RISPERIDONE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	7
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	RISPERIDONE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	7
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	RISPERIDONE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	7
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	RISPERIDONE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	7
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	RISPERIDONE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	7
RISPERIDONE	ACTIVE INGREDIENT	L6UH7ZF8HC	RISPERIDONE TABLET, FILM COATED [TYA PHARMACEUTICALS]	4
RISPERIDONE	ACTIVE MOIETY	L6UH7ZF8HC	RISPERIDONE TABLET, FILM COATED [TYA PHARMACEUTICALS]	4
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	RISPERIDONE TABLET, FILM COATED [TYA PHARMACEUTICALS]	4
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	RISPERIDONE TABLET, FILM COATED [TYA PHARMACEUTICALS]	4
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	RISPERIDONE TABLET, FILM COATED [TYA PHARMACEUTICALS]	4
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	RISPERIDONE TABLET, FILM COATED [TYA PHARMACEUTICALS]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	RISPERIDONE TABLET, FILM COATED [TYA PHARMACEUTICALS]	4
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	RISPERIDONE TABLET, FILM COATED [TYA PHARMACEUTICALS]	4
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	RISPERIDONE TABLET, FILM COATED [TYA PHARMACEUTICALS]	4
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	RISPERIDONE TABLET, FILM COATED [TYA PHARMACEUTICALS]	4
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	RISPERIDONE TABLET, FILM COATED [TYA PHARMACEUTICALS]	4
RISPERIDONE	ACTIVE INGREDIENT	L6UH7ZF8HC	RISPERIDONE TABLET [CONTRACT PHARMACY SERVICES-PA]	1
RISPERIDONE	ACTIVE MOIETY	L6UH7ZF8HC	RISPERIDONE TABLET [CONTRACT PHARMACY SERVICES-PA]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	RISPERIDONE TABLET [CONTRACT PHARMACY SERVICES-PA]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	RISPERIDONE TABLET [CONTRACT PHARMACY SERVICES-PA]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	RISPERIDONE TABLET [CONTRACT PHARMACY SERVICES-PA]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	RISPERIDONE TABLET [CONTRACT PHARMACY SERVICES-PA]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	RISPERIDONE TABLET [CONTRACT PHARMACY SERVICES-PA]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	RISPERIDONE TABLET [CONTRACT PHARMACY SERVICES-PA]	1
HYPROMELLOSE	INACTIVE INGREDIENT	3NXW29V3WO	RISPERIDONE TABLET [CONTRACT PHARMACY SERVICES-PA]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	RISPERIDONE TABLET [CONTRACT PHARMACY SERVICES-PA]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	RISPERIDONE TABLET [CONTRACT PHARMACY SERVICES-PA]	1
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	RISPERIDONE TABLET [CONTRACT PHARMACY SERVICES-PA]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	RISPERIDONE TABLET [CONTRACT PHARMACY SERVICES-PA]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	RISPERIDONE TABLET [CONTRACT PHARMACY SERVICES-PA]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	RISPERIDONE TABLET [CONTRACT PHARMACY SERVICES-PA]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	RISPERIDONE TABLET [CONTRACT PHARMACY SERVICES-PA]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68382-113	RISPERIDONE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS USA INC.]	24	Current NDC, Legacy NDC, 6 package rows	20250216_713b5ac7-53d6-4139-8599-3028f789de4b.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
L6UH7ZF8HC	RISPERIDONE	106266-06-2	RISPERIDONE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
312828	risperiDONE 0.25 MG Oral Tablet	PSN	713b5ac7-53d6-4139-8599-3028f789de4b	25
312829	risperiDONE 0.5 MG Oral Tablet	PSN	713b5ac7-53d6-4139-8599-3028f789de4b	25
312830	risperiDONE 1 MG Oral Tablet	PSN	713b5ac7-53d6-4139-8599-3028f789de4b	25
312831	risperiDONE 2 MG Oral Tablet	PSN	713b5ac7-53d6-4139-8599-3028f789de4b	25
312832	risperiDONE 3 MG Oral Tablet	PSN	713b5ac7-53d6-4139-8599-3028f789de4b	25
314211	risperiDONE 4 MG Oral Tablet	PSN	713b5ac7-53d6-4139-8599-3028f789de4b	25
312828	risperidone 0.25 MG Oral Tablet	SCD	713b5ac7-53d6-4139-8599-3028f789de4b	25
312829	risperidone 0.5 MG Oral Tablet	SCD	713b5ac7-53d6-4139-8599-3028f789de4b	25
312830	risperidone 1 MG Oral Tablet	SCD	713b5ac7-53d6-4139-8599-3028f789de4b	25
312831	risperidone 2 MG Oral Tablet	SCD	713b5ac7-53d6-4139-8599-3028f789de4b	25
312832	risperidone 3 MG Oral Tablet	SCD	713b5ac7-53d6-4139-8599-3028f789de4b	25
314211	risperidone 4 MG Oral Tablet	SCD	713b5ac7-53d6-4139-8599-3028f789de4b	25
312828	risperiDONE 0.25 MG Oral Tablet	PSN	f11dae15-b057-4258-9229-3819d0c980fe	16
312829	risperiDONE 0.5 MG Oral Tablet	PSN	f11dae15-b057-4258-9229-3819d0c980fe	16
312830	risperiDONE 1 MG Oral Tablet	PSN	f11dae15-b057-4258-9229-3819d0c980fe	16
312831	risperiDONE 2 MG Oral Tablet	PSN	f11dae15-b057-4258-9229-3819d0c980fe	16
312832	risperiDONE 3 MG Oral Tablet	PSN	f11dae15-b057-4258-9229-3819d0c980fe	16
314211	risperiDONE 4 MG Oral Tablet	PSN	f11dae15-b057-4258-9229-3819d0c980fe	16
312828	risperidone 0.25 MG Oral Tablet	SCD	f11dae15-b057-4258-9229-3819d0c980fe	16
312829	risperidone 0.5 MG Oral Tablet	SCD	f11dae15-b057-4258-9229-3819d0c980fe	16
312830	risperidone 1 MG Oral Tablet	SCD	f11dae15-b057-4258-9229-3819d0c980fe	16
312831	risperidone 2 MG Oral Tablet	SCD	f11dae15-b057-4258-9229-3819d0c980fe	16
312832	risperidone 3 MG Oral Tablet	SCD	f11dae15-b057-4258-9229-3819d0c980fe	16
314211	risperidone 4 MG Oral Tablet	SCD	f11dae15-b057-4258-9229-3819d0c980fe	16
312828	risperiDONE 0.25 MG Oral Tablet	PSN	d5abd75f-7f4a-4a7d-b849-82fce88f5ff7	4
312829	risperiDONE 0.5 MG Oral Tablet	PSN	10bf6ea7-fc6d-4cf1-8074-f80f6af9cf5c	4
312829	risperiDONE 0.5 MG Oral Tablet	PSN	d5abd75f-7f4a-4a7d-b849-82fce88f5ff7	4
312830	risperiDONE 1 MG Oral Tablet	PSN	10bf6ea7-fc6d-4cf1-8074-f80f6af9cf5c	4
312830	risperiDONE 1 MG Oral Tablet	PSN	d5abd75f-7f4a-4a7d-b849-82fce88f5ff7	4
312831	risperiDONE 2 MG Oral Tablet	PSN	d5abd75f-7f4a-4a7d-b849-82fce88f5ff7	4
312832	risperiDONE 3 MG Oral Tablet	PSN	d5abd75f-7f4a-4a7d-b849-82fce88f5ff7	4
314211	risperiDONE 4 MG Oral Tablet	PSN	d5abd75f-7f4a-4a7d-b849-82fce88f5ff7	4
312828	risperidone 0.25 MG Oral Tablet	SCD	d5abd75f-7f4a-4a7d-b849-82fce88f5ff7	4
312829	risperidone 0.5 MG Oral Tablet	SCD	10bf6ea7-fc6d-4cf1-8074-f80f6af9cf5c	4
312829	risperidone 0.5 MG Oral Tablet	SCD	d5abd75f-7f4a-4a7d-b849-82fce88f5ff7	4
312830	risperidone 1 MG Oral Tablet	SCD	d5abd75f-7f4a-4a7d-b849-82fce88f5ff7	4
312830	risperidone 1 MG Oral Tablet	SCD	10bf6ea7-fc6d-4cf1-8074-f80f6af9cf5c	4
312831	risperidone 2 MG Oral Tablet	SCD	d5abd75f-7f4a-4a7d-b849-82fce88f5ff7	4
312832	risperidone 3 MG Oral Tablet	SCD	d5abd75f-7f4a-4a7d-b849-82fce88f5ff7	4
314211	risperidone 4 MG Oral Tablet	SCD	d5abd75f-7f4a-4a7d-b849-82fce88f5ff7	4
312828	risperiDONE 0.25 MG Oral Tablet	PSN	2e5c6b7f-1d57-4114-9067-79dca009c4cc	1
312829	risperiDONE 0.5 MG Oral Tablet	PSN	2e5c6b7f-1d57-4114-9067-79dca009c4cc	1
312830	risperiDONE 1 MG Oral Tablet	PSN	2e5c6b7f-1d57-4114-9067-79dca009c4cc	1
312831	risperiDONE 2 MG Oral Tablet	PSN	2e5c6b7f-1d57-4114-9067-79dca009c4cc	1
312832	risperiDONE 3 MG Oral Tablet	PSN	2e5c6b7f-1d57-4114-9067-79dca009c4cc	1
314211	risperiDONE 4 MG Oral Tablet	PSN	2e5c6b7f-1d57-4114-9067-79dca009c4cc	1
312828	risperidone 0.25 MG Oral Tablet	SCD	2e5c6b7f-1d57-4114-9067-79dca009c4cc	1
312829	risperidone 0.5 MG Oral Tablet	SCD	2e5c6b7f-1d57-4114-9067-79dca009c4cc	1
312830	risperidone 1 MG Oral Tablet	SCD	2e5c6b7f-1d57-4114-9067-79dca009c4cc	1
312831	risperidone 2 MG Oral Tablet	SCD	2e5c6b7f-1d57-4114-9067-79dca009c4cc	1
312832	risperidone 3 MG Oral Tablet	SCD	2e5c6b7f-1d57-4114-9067-79dca009c4cc	1
314211	risperidone 4 MG Oral Tablet	SCD	2e5c6b7f-1d57-4114-9067-79dca009c4cc	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
68382-113-01	68382011301	100 TABLET, FILM COATED in 1 BOTTLE (68382-113-01)	2008-11-13	0000-00-00	No	No	Current
68382-113-05	68382011305	500 TABLET, FILM COATED in 1 BOTTLE (68382-113-05)	2008-11-13	0000-00-00	No	No	Current
68382-113-06	68382011306	30 TABLET, FILM COATED in 1 BOTTLE (68382-113-06)	2008-11-13	0000-00-00	No	No	Current
68382-113-10	68382011310	1000 TABLET, FILM COATED in 1 BOTTLE (68382-113-10)	2008-11-13	0000-00-00	No	No	Current
68382-113-14	68382011314	60 TABLET, FILM COATED in 1 BOTTLE (68382-113-14)	2008-11-13	0000-00-00	No	No	Current
68382-113-16	68382011316	90 TABLET, FILM COATED in 1 BOTTLE (68382-113-16)	2008-11-13	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
risperidone	Major Pharmaceuticals	2026-01-02	HUMAN PRESCRIPTION DRUG LABEL	4
Risperidone	American Health Packaging	2025-11-18	HUMAN PRESCRIPTION DRUG LABEL	16
risperidone	Zydus Pharmaceuticals USA Inc. \| Zydus Lifesciences Limited	2025-06-14	HUMAN PRESCRIPTION DRUG LABEL	25
risperidone	TYA Pharmaceuticals	2014-05-07	HUMAN PRESCRIPTION DRUG LABEL	4
Risperidone	Contract Pharmacy Services-PA	2010-08-25	HUMAN PRESCRIPTION DRUG LABEL	1

risperidone

Additional Listing Data#

Related Records#

Active Ingredients#

Harmonized Identifiers#

DailyMed Product Concepts#

DailyMed Package Descriptions#

DailyMed Billing Units#

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

Related Records#

Related UNII Ingredients#

DailyMed RxNorm Mappings#

Packages#

Related DailyMed Labels#