RISPERIDONE

Product NDC: 87564-016
11-digit product format: 875640016
Labeler code: 87564
Product ID: 87564-016_58b7505e-32cb-ef57-e063-6394a90abca1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: RISPERIDONE
Dosage form: TABLET, ORALLY DISINTEGRATING
Route: ORAL
Labeler: Amerisyn LLC
Application: ANDA077328
Marketing category: ANDA
Marketing start: 2026-08-06
Substance: RISPERIDONE
Active strength: 3 mg/1
Pharmacologic classes: Atypical Antipsychotic [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
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 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A077328-001	RISPERIDONE	RISPERIDONE	0.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-02-24
A077328-002	RISPERIDONE	RISPERIDONE	1MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-10-05
A077328-003	RISPERIDONE	RISPERIDONE	2MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-02-24
A077328-004	RISPERIDONE	RISPERIDONE	3MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-11-30
A077328-005	RISPERIDONE	RISPERIDONE	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-11-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-product	TE code
A077328-001	AB
A077328-002	AB
A077328-003	AB
A077328-004	AB
A077328-005	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 6 · 215 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	A077328-001	RISPERIDONE	0.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-02-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077328-002	RISPERIDONE	1MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-10-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077328-003	RISPERIDONE	2MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-02-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077328-004	RISPERIDONE	3MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-11-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077328-005	RISPERIDONE	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-11-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077328-001	RISPERIDONE	0.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-02-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077328-002	RISPERIDONE	1MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-10-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077328-003	RISPERIDONE	2MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-02-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077328-004	RISPERIDONE	3MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-11-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077328-005	RISPERIDONE	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-11-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077328-001	RISPERIDONE	0.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-02-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077328-002	RISPERIDONE	1MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-10-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077328-003	RISPERIDONE	2MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-02-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077328-004	RISPERIDONE	3MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-11-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077328-005	RISPERIDONE	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-11-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077328-001	RISPERIDONE	0.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-02-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077328-002	RISPERIDONE	1MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-10-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077328-003	RISPERIDONE	2MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-02-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077328-004	RISPERIDONE	3MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-11-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077328-005	RISPERIDONE	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-11-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077328-001	RISPERIDONE	0.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-02-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077328-002	RISPERIDONE	1MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-10-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077328-003	RISPERIDONE	2MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-02-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077328-004	RISPERIDONE	3MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-11-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077328-005	RISPERIDONE	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-11-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077328-001	RISPERIDONE	0.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-02-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077328-002	RISPERIDONE	1MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-10-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077328-003	RISPERIDONE	2MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-02-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077328-004	RISPERIDONE	3MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-11-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077328-005	RISPERIDONE	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-11-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077328-001	RISPERIDONE	0.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-02-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077328-002	RISPERIDONE	1MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-10-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077328-003	RISPERIDONE	2MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-02-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077328-004	RISPERIDONE	3MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-11-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077328-005	RISPERIDONE	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-11-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077328-001	RISPERIDONE	0.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-02-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077328-002	RISPERIDONE	1MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-10-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077328-003	RISPERIDONE	2MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-02-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077328-004	RISPERIDONE	3MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-11-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077328-005	RISPERIDONE	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-11-30	`03ed91905a0d…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 215 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	A077328-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077328-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077328-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077328-004	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077328-005	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077328-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077328-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077328-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077328-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077328-005	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077328-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077328-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077328-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077328-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077328-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077328-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077328-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077328-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077328-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077328-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077328-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077328-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077328-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077328-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077328-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077328-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077328-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077328-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077328-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077328-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077328-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077328-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077328-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077328-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077328-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077328-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077328-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077328-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077328-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077328-005	AB	1	`03ed91905a0d…`

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: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
RISPERIDONE	3 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 · 5 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
401953	Internal RxNorm lookup
401954	Internal RxNorm lookup
403825	Internal RxNorm lookup
616698	Internal RxNorm lookup
616705	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
58b7504f-c4a3-ef1b-e063-6394a90ac0f3	Available on FDA.report

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
RISPERIDONE	RISPERIDONE	Amerisyn LLC	58b7504f-c4a3-ef1b-e063-6394a90ac0f3	2026-08-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077328 application number: ANDA077328 ndc (product): 87564-016
Risperidone	RISPERIDONE	Amici Pharma, Inc.	ca41c144-224a-4d57-88d7-8778e6c69ed2	2026-03-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077328 application number: ANDA077328

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
87564-016-28	87564001628	4 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (87564-016-28)	2026-08-06	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
RISPERIDONE	Amerisyn LLC \| Havix Group Inc d-b-a Aavis Pharmaceuticals	2026-08-10	HUMAN PRESCRIPTION DRUG LABEL	1