Risperidone

Product NDC: 69367-368
Requested package NDC: 69367-368-60
11-digit product format: 693670368
Labeler code: 69367
Product ID: 69367-368_4559701f-b153-5434-e063-6294a90a6d1d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Risperidone
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Westminster Pharmaceuticals, LLC
Application: ANDA078707
Marketing category: ANDA
Marketing start: 2024-09-09
Substance: RISPERIDONE
Active strength: .25 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
A078707-001	RISPERIDONE	RISPERIDONE	0.25MG	TABLET / ORAL	AB	2008-12-29
A078707-002	RISPERIDONE	RISPERIDONE	0.5MG	TABLET / ORAL	AB	2008-12-29
A078707-003	RISPERIDONE	RISPERIDONE	1MG	TABLET / ORAL	AB	2008-12-29
A078707-004	RISPERIDONE	RISPERIDONE	2MG	TABLET / ORAL	AB	2008-12-29
A078707-005	RISPERIDONE	RISPERIDONE	3MG	TABLET / ORAL	AB	2008-12-29
A078707-006	RISPERIDONE	RISPERIDONE	4MG	TABLET / ORAL	AB	2008-12-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078707-001	AB
A078707-002	AB
A078707-003	AB
A078707-004	AB
A078707-005	AB
A078707-006	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	A078707-001	RISPERIDONE	0.25MG	TABLET / ORAL	AB	2008-12-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078707-002	RISPERIDONE	0.5MG	TABLET / ORAL	AB	2008-12-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078707-003	RISPERIDONE	1MG	TABLET / ORAL	AB	2008-12-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078707-004	RISPERIDONE	2MG	TABLET / ORAL	AB	2008-12-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078707-005	RISPERIDONE	3MG	TABLET / ORAL	AB	2008-12-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078707-006	RISPERIDONE	4MG	TABLET / ORAL	AB	2008-12-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078707-001	RISPERIDONE	0.25MG	TABLET / ORAL	AB	2008-12-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078707-002	RISPERIDONE	0.5MG	TABLET / ORAL	AB	2008-12-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078707-003	RISPERIDONE	1MG	TABLET / ORAL	AB	2008-12-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078707-004	RISPERIDONE	2MG	TABLET / ORAL	AB	2008-12-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078707-005	RISPERIDONE	3MG	TABLET / ORAL	AB	2008-12-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078707-006	RISPERIDONE	4MG	TABLET / ORAL	AB	2008-12-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078707-001	RISPERIDONE	0.25MG	TABLET / ORAL	AB	2008-12-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078707-002	RISPERIDONE	0.5MG	TABLET / ORAL	AB	2008-12-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078707-003	RISPERIDONE	1MG	TABLET / ORAL	AB	2008-12-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078707-004	RISPERIDONE	2MG	TABLET / ORAL	AB	2008-12-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078707-005	RISPERIDONE	3MG	TABLET / ORAL	AB	2008-12-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078707-006	RISPERIDONE	4MG	TABLET / ORAL	AB	2008-12-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078707-001	RISPERIDONE	0.25MG	TABLET / ORAL	AB	2008-12-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078707-002	RISPERIDONE	0.5MG	TABLET / ORAL	AB	2008-12-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078707-003	RISPERIDONE	1MG	TABLET / ORAL	AB	2008-12-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078707-004	RISPERIDONE	2MG	TABLET / ORAL	AB	2008-12-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078707-005	RISPERIDONE	3MG	TABLET / ORAL	AB	2008-12-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078707-006	RISPERIDONE	4MG	TABLET / ORAL	AB	2008-12-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078707-001	RISPERIDONE	0.25MG	TABLET / ORAL	AB	2008-12-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078707-002	RISPERIDONE	0.5MG	TABLET / ORAL	AB	2008-12-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078707-003	RISPERIDONE	1MG	TABLET / ORAL	AB	2008-12-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078707-004	RISPERIDONE	2MG	TABLET / ORAL	AB	2008-12-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078707-005	RISPERIDONE	3MG	TABLET / ORAL	AB	2008-12-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078707-006	RISPERIDONE	4MG	TABLET / ORAL	AB	2008-12-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078707-001	RISPERIDONE	0.25MG	TABLET / ORAL	AB	2008-12-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078707-002	RISPERIDONE	0.5MG	TABLET / ORAL	AB	2008-12-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078707-003	RISPERIDONE	1MG	TABLET / ORAL	AB	2008-12-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078707-004	RISPERIDONE	2MG	TABLET / ORAL	AB	2008-12-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078707-005	RISPERIDONE	3MG	TABLET / ORAL	AB	2008-12-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078707-006	RISPERIDONE	4MG	TABLET / ORAL	AB	2008-12-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078707-001	RISPERIDONE	0.25MG	TABLET / ORAL	AB	2008-12-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078707-002	RISPERIDONE	0.5MG	TABLET / ORAL	AB	2008-12-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078707-003	RISPERIDONE	1MG	TABLET / ORAL	AB	2008-12-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078707-004	RISPERIDONE	2MG	TABLET / ORAL	AB	2008-12-29	`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	A078707-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078707-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078707-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078707-004	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078707-005	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078707-006	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078707-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078707-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078707-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078707-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078707-005	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078707-006	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078707-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078707-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078707-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078707-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078707-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078707-006	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078707-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078707-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078707-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078707-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078707-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078707-006	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078707-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078707-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078707-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078707-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078707-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078707-006	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078707-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078707-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078707-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078707-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078707-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078707-006	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078707-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078707-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078707-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078707-004	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	.25 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
07d43bf6-a695-453a-a5c7-9581effe585c	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
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
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
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69367-368-05	Risperidone	500 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	500		6
69367-368-60	Risperidone	60 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	60		6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69367-368-05	EA - Each	69367-368	a73c15b8-05fd-4740-b137-63f7c69bee56	1	2024-12-10
69367-368-60	EA - Each	69367-368	caaaa4c1-cf5c-47d5-bfa5-71c89b9652af	1	2024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69367-368	RISPERIDONE TABLET, FILM COATED [WESTMINSTER PHARMACEUTICALS, LLC]	5	Current NDC, 2 package rows	20250511_07d43bf6-a695-453a-a5c7-9581effe585c.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Risperidone	RISPERIDONE	Westminster Pharmaceuticals, LLC	07d43bf6-a695-453a-a5c7-9581effe585c	2025-12-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078707 application number: ANDA078707 ndc (package): 69367-368-60 ndc (product): 69367-368 ndc11 (package): 69367036860
Risperidone	RISPERIDONE	AvKARE	3d4c51e2-b09b-9fd0-e063-6294a90ae699	2025-08-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078707 application number: ANDA078707
Risperidone	RISPERIDONE	AvKARE	2f9ea0cc-b86b-a11f-e063-6294a90a9620	2025-03-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078707 application number: ANDA078707

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	07d43bf6-a695-453a-a5c7-9581effe585c	6
312829	risperiDONE 0.5 MG Oral Tablet	PSN	07d43bf6-a695-453a-a5c7-9581effe585c	6
312830	risperiDONE 1 MG Oral Tablet	PSN	07d43bf6-a695-453a-a5c7-9581effe585c	6
312831	risperiDONE 2 MG Oral Tablet	PSN	07d43bf6-a695-453a-a5c7-9581effe585c	6
312832	risperiDONE 3 MG Oral Tablet	PSN	07d43bf6-a695-453a-a5c7-9581effe585c	6
314211	risperiDONE 4 MG Oral Tablet	PSN	07d43bf6-a695-453a-a5c7-9581effe585c	6
312828	risperidone 0.25 MG Oral Tablet	SCD	07d43bf6-a695-453a-a5c7-9581effe585c	6
312829	risperidone 0.5 MG Oral Tablet	SCD	07d43bf6-a695-453a-a5c7-9581effe585c	6
312830	risperidone 1 MG Oral Tablet	SCD	07d43bf6-a695-453a-a5c7-9581effe585c	6
312831	risperidone 2 MG Oral Tablet	SCD	07d43bf6-a695-453a-a5c7-9581effe585c	6
312832	risperidone 3 MG Oral Tablet	SCD	07d43bf6-a695-453a-a5c7-9581effe585c	6
314211	risperidone 4 MG Oral Tablet	SCD	07d43bf6-a695-453a-a5c7-9581effe585c	6
312828	risperiDONE 0.25 MG Oral Tablet	PSN	2f9ea0cc-b86b-a11f-e063-6294a90a9620	2
312829	risperiDONE 0.5 MG Oral Tablet	PSN	2f9ea0cc-b86b-a11f-e063-6294a90a9620	2
312830	risperiDONE 1 MG Oral Tablet	PSN	2f9ea0cc-b86b-a11f-e063-6294a90a9620	2
312828	risperidone 0.25 MG Oral Tablet	SCD	2f9ea0cc-b86b-a11f-e063-6294a90a9620	2
312829	risperidone 0.5 MG Oral Tablet	SCD	2f9ea0cc-b86b-a11f-e063-6294a90a9620	2
312830	risperidone 1 MG Oral Tablet	SCD	2f9ea0cc-b86b-a11f-e063-6294a90a9620	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
69367-368-60	69367036860	60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69367-368-60)	2024-09-09	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Risperidone	Westminster Pharmaceuticals, LLC \| Renata PLC \| 3014008486	2025-12-07	HUMAN PRESCRIPTION DRUG LABEL	6
Risperidone	AvKARE	2025-03-19	HUMAN PRESCRIPTION DRUG LABEL	2