risperidone

Product NDC: 68382-117
11-digit product format: 683820117
Labeler code: 68382
Product ID: 68382-117_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: 4 mg/1
Pharmacologic classes: Atypical Antipsychotic [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A078040-001	RISPERIDONE	RISPERIDONE	0.25MG	TABLET / ORAL	AB	2008-10-16
A078040-002	RISPERIDONE	RISPERIDONE	0.5MG	TABLET / ORAL	AB	2008-10-16
A078040-003	RISPERIDONE	RISPERIDONE	1MG	TABLET / ORAL	AB	2008-10-16
A078040-004	RISPERIDONE	RISPERIDONE	2MG	TABLET / ORAL	AB	2008-10-16
A078040-005	RISPERIDONE	RISPERIDONE	3MG	TABLET / ORAL	AB	2008-10-16
A078040-006	RISPERIDONE	RISPERIDONE	4MG	TABLET / ORAL	AB	2008-10-16

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 6 matching rows.

Application-product, TE code table
Application-product	TE code
A078040-001	AB
A078040-002	AB
A078040-003	AB
A078040-004	AB
A078040-005	AB
A078040-006	AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 7 · 258 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A078040-001	RISPERIDONE	0.25MG	TABLET / ORAL	AB	2008-10-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078040-002	RISPERIDONE	0.5MG	TABLET / ORAL	AB	2008-10-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078040-003	RISPERIDONE	1MG	TABLET / ORAL	AB	2008-10-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078040-004	RISPERIDONE	2MG	TABLET / ORAL	AB	2008-10-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078040-005	RISPERIDONE	3MG	TABLET / ORAL	AB	2008-10-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078040-006	RISPERIDONE	4MG	TABLET / ORAL	AB	2008-10-16	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078040-001	RISPERIDONE	0.25MG	TABLET / ORAL	AB	2008-10-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078040-002	RISPERIDONE	0.5MG	TABLET / ORAL	AB	2008-10-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078040-003	RISPERIDONE	1MG	TABLET / ORAL	AB	2008-10-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078040-004	RISPERIDONE	2MG	TABLET / ORAL	AB	2008-10-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078040-005	RISPERIDONE	3MG	TABLET / ORAL	AB	2008-10-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078040-006	RISPERIDONE	4MG	TABLET / ORAL	AB	2008-10-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078040-001	RISPERIDONE	0.25MG	TABLET / ORAL	AB	2008-10-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078040-002	RISPERIDONE	0.5MG	TABLET / ORAL	AB	2008-10-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078040-003	RISPERIDONE	1MG	TABLET / ORAL	AB	2008-10-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078040-004	RISPERIDONE	2MG	TABLET / ORAL	AB	2008-10-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078040-005	RISPERIDONE	3MG	TABLET / ORAL	AB	2008-10-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078040-006	RISPERIDONE	4MG	TABLET / ORAL	AB	2008-10-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078040-001	RISPERIDONE	0.25MG	TABLET / ORAL	AB	2008-10-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078040-002	RISPERIDONE	0.5MG	TABLET / ORAL	AB	2008-10-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078040-003	RISPERIDONE	1MG	TABLET / ORAL	AB	2008-10-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078040-004	RISPERIDONE	2MG	TABLET / ORAL	AB	2008-10-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078040-005	RISPERIDONE	3MG	TABLET / ORAL	AB	2008-10-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078040-006	RISPERIDONE	4MG	TABLET / ORAL	AB	2008-10-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078040-001	RISPERIDONE	0.25MG	TABLET / ORAL	AB	2008-10-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078040-002	RISPERIDONE	0.5MG	TABLET / ORAL	AB	2008-10-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078040-003	RISPERIDONE	1MG	TABLET / ORAL	AB	2008-10-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078040-004	RISPERIDONE	2MG	TABLET / ORAL	AB	2008-10-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078040-005	RISPERIDONE	3MG	TABLET / ORAL	AB	2008-10-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078040-006	RISPERIDONE	4MG	TABLET / ORAL	AB	2008-10-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078040-001	RISPERIDONE	0.25MG	TABLET / ORAL	AB	2008-10-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078040-002	RISPERIDONE	0.5MG	TABLET / ORAL	AB	2008-10-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078040-003	RISPERIDONE	1MG	TABLET / ORAL	AB	2008-10-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078040-004	RISPERIDONE	2MG	TABLET / ORAL	AB	2008-10-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078040-005	RISPERIDONE	3MG	TABLET / ORAL	AB	2008-10-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078040-006	RISPERIDONE	4MG	TABLET / ORAL	AB	2008-10-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078040-001	RISPERIDONE	0.25MG	TABLET / ORAL	AB	2008-10-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078040-002	RISPERIDONE	0.5MG	TABLET / ORAL	AB	2008-10-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078040-003	RISPERIDONE	1MG	TABLET / ORAL	AB	2008-10-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078040-004	RISPERIDONE	2MG	TABLET / ORAL	AB	2008-10-16	`b8a1b40f171c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 258 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A078040-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078040-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078040-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078040-004	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078040-005	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078040-006	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078040-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078040-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078040-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078040-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078040-005	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078040-006	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078040-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078040-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078040-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078040-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078040-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078040-006	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078040-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078040-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078040-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078040-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078040-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078040-006	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078040-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078040-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078040-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078040-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078040-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078040-006	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078040-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078040-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078040-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078040-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078040-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078040-006	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078040-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078040-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078040-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078040-004	AB	1	`b8a1b40f171c…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
RISPERIDONE	4 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
L6UH7ZF8HC	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
312828	Internal RxNorm lookup
312829	Internal RxNorm lookup
312830	Internal RxNorm lookup
312831	Internal RxNorm lookup
312832	Internal RxNorm lookup
314211	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
713b5ac7-53d6-4139-8599-3028f789de4b	Available on FDA.report

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
68382-117-01	risperidone	100 in 1 BOTTLE	TABLET, FILM COATED	100	25
68382-117-05	risperidone	500 in 1 BOTTLE	TABLET, FILM COATED	500	25
68382-117-06	risperidone	30 in 1 BOTTLE	TABLET, FILM COATED	30	25
68382-117-10	risperidone	1000 in 1 BOTTLE	TABLET, FILM COATED	1000	25
68382-117-14	risperidone	60 in 1 BOTTLE	TABLET, FILM COATED	60	25
68382-117-16	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
68382-117-05	EA - Each	68382-117	3ec7fd2e-b6f3-4657-880f-a2ee9d55f715	1	2012-07-24
68382-117-14	EA - Each	68382-117	4842e3b1-206e-47a6-96e6-84e7dc84b58b	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 (RISPERIDONE) TABLET, FILM COATED [AVPAK]	2
RISPERIDONE	ACTIVE MOIETY	L6UH7ZF8HC	RISPERIDONE (RISPERIDONE) TABLET, FILM COATED [AVPAK]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	RISPERIDONE (RISPERIDONE) TABLET, FILM COATED [AVPAK]	2
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	RISPERIDONE (RISPERIDONE) TABLET, FILM COATED [AVPAK]	2
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	RISPERIDONE (RISPERIDONE) TABLET, FILM COATED [AVPAK]	2
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	RISPERIDONE (RISPERIDONE) TABLET, FILM COATED [AVPAK]	2
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	RISPERIDONE (RISPERIDONE) TABLET, FILM COATED [AVPAK]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	RISPERIDONE (RISPERIDONE) TABLET, FILM COATED [AVPAK]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	RISPERIDONE (RISPERIDONE) TABLET, FILM COATED [AVPAK]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	RISPERIDONE (RISPERIDONE) TABLET, FILM COATED [AVPAK]	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	RISPERIDONE (RISPERIDONE) TABLET, FILM COATED [AVPAK]	2
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	RISPERIDONE (RISPERIDONE) TABLET, FILM COATED [AVPAK]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	RISPERIDONE (RISPERIDONE) TABLET, FILM COATED [AVPAK]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	RISPERIDONE (RISPERIDONE) TABLET, FILM COATED [AVPAK]	2
RISPERIDONE	ACTIVE INGREDIENT	L6UH7ZF8HC	RISPERIDONE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
RISPERIDONE	ACTIVE INGREDIENT	L6UH7ZF8HC	RISPERIDONE TABLET [CONTRACT PHARMACY SERVICES-PA]	1
RISPERIDONE	ACTIVE INGREDIENT	L6UH7ZF8HC	RISPERIDONE TABLET, FILM COATED [CLINICAL SOLUTIONS WHOLESALE, LLC]	1
RISPERIDONE	ACTIVE MOIETY	L6UH7ZF8HC	RISPERIDONE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
RISPERIDONE	ACTIVE MOIETY	L6UH7ZF8HC	RISPERIDONE TABLET, FILM COATED [CLINICAL SOLUTIONS WHOLESALE, LLC]	1
RISPERIDONE	ACTIVE MOIETY	L6UH7ZF8HC	RISPERIDONE TABLET [CONTRACT PHARMACY SERVICES-PA]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	RISPERIDONE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	RISPERIDONE TABLET, FILM COATED [CLINICAL SOLUTIONS WHOLESALE, LLC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	RISPERIDONE TABLET [CONTRACT PHARMACY SERVICES-PA]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	RISPERIDONE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	RISPERIDONE TABLET [CONTRACT PHARMACY SERVICES-PA]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	RISPERIDONE TABLET, FILM COATED [CLINICAL SOLUTIONS WHOLESALE, LLC]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	RISPERIDONE TABLET, FILM COATED [CLINICAL SOLUTIONS WHOLESALE, LLC]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	RISPERIDONE TABLET [CONTRACT PHARMACY SERVICES-PA]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	RISPERIDONE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	RISPERIDONE TABLET [CONTRACT PHARMACY SERVICES-PA]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	RISPERIDONE TABLET, FILM COATED [CLINICAL SOLUTIONS WHOLESALE, LLC]	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
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	RISPERIDONE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	RISPERIDONE TABLET, FILM COATED [CLINICAL SOLUTIONS WHOLESALE, LLC]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	RISPERIDONE TABLET, FILM COATED [CLINICAL SOLUTIONS WHOLESALE, LLC]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	RISPERIDONE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	RISPERIDONE TABLET [CONTRACT PHARMACY SERVICES-PA]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	RISPERIDONE TABLET, FILM COATED [CLINICAL SOLUTIONS WHOLESALE, LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	RISPERIDONE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	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, FILM COATED [CLINICAL SOLUTIONS WHOLESALE, LLC]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	RISPERIDONE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	RISPERIDONE TABLET [CONTRACT PHARMACY SERVICES-PA]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	RISPERIDONE TABLET, FILM COATED [CLINICAL SOLUTIONS WHOLESALE, LLC]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	RISPERIDONE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	RISPERIDONE TABLET [CONTRACT PHARMACY SERVICES-PA]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	RISPERIDONE TABLET, FILM COATED [CLINICAL SOLUTIONS WHOLESALE, LLC]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	RISPERIDONE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	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
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	RISPERIDONE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	RISPERIDONE TABLET, FILM COATED [CLINICAL SOLUTIONS WHOLESALE, LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68382-117	RISPERIDONE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS USA INC.]	24	Current NDC, Legacy NDC, 6 package rows	20250216_713b5ac7-53d6-4139-8599-3028f789de4b.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
risperidone	RISPERIDONE	Cardinal Health 107, LLC	3ce21196-4aa0-469b-8f04-6650b2c48cb5	2026-04-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078040 application number: ANDA078040
risperidone	RISPERIDONE	Major Pharmaceuticals	d5abd75f-7f4a-4a7d-b849-82fce88f5ff7	2026-01-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078040 application number: ANDA078040
Risperidone	RISPERIDONE	American Health Packaging	f11dae15-b057-4258-9229-3819d0c980fe	2025-11-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078040 application number: ANDA078040
risperidone	RISPERIDONE	Zydus Pharmaceuticals USA Inc.	713b5ac7-53d6-4139-8599-3028f789de4b	2025-06-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078040 application number: ANDA078040 ndc (product): 68382-117
risperidone	RISPERIDONE	Zydus Lifesciences Limited	23993d21-80bf-41c4-b57d-88a620173b6b	2024-08-12		Exact identifier application applno (ANDA): 078040 application number: ANDA078040
risperidone	RISPERIDONE	Proficient Rx LP	b611fe52-1787-47e6-8a6b-1999a4e4f22c	2021-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078040 application number: ANDA078040

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	d5abd75f-7f4a-4a7d-b849-82fce88f5ff7	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	d5abd75f-7f4a-4a7d-b849-82fce88f5ff7	4
312830	risperidone 1 MG Oral Tablet	SCD	d5abd75f-7f4a-4a7d-b849-82fce88f5ff7	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
314211	risperiDONE 4 MG Oral Tablet	PSN	15e5409a-8d93-4c0a-b7f0-1c8d5d918903	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	15e5409a-8d93-4c0a-b7f0-1c8d5d918903	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
68382-117-01	68382011701	100 TABLET, FILM COATED in 1 BOTTLE (68382-117-01)	2008-11-13	0000-00-00	No	No	Current
68382-117-05	68382011705	500 TABLET, FILM COATED in 1 BOTTLE (68382-117-05)	2008-11-13	0000-00-00	No	No	Current
68382-117-06	68382011706	30 TABLET, FILM COATED in 1 BOTTLE (68382-117-06)	2008-11-13	0000-00-00	No	No	Current
68382-117-10	68382011710	1000 TABLET, FILM COATED in 1 BOTTLE (68382-117-10)	2008-11-13	0000-00-00	No	No	Current
68382-117-14	68382011714	60 TABLET, FILM COATED in 1 BOTTLE (68382-117-14)	2008-11-13	0000-00-00	No	No	Current
68382-117-16	68382011716	90 TABLET, FILM COATED in 1 BOTTLE (68382-117-16)	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	AvPAK	2022-01-18	HUMAN PRESCRIPTION DRUG LABEL	4
risperidone	Clinical Solutions Wholesale, LLC	2020-09-25	HUMAN PRESCRIPTION DRUG LABEL	6
risperidone	REMEDYREPACK INC.	2019-05-23	HUMAN PRESCRIPTION DRUG LABEL	1
risperidone	State of Florida DOH Central Pharmacy	2015-01-18	HUMAN PRESCRIPTION DRUG LABEL	1
Risperidone	Contract Pharmacy Services-PA	2010-08-25	HUMAN PRESCRIPTION DRUG LABEL	1