Risperidone

Product NDC: 69292-571
11-digit product format: 692920571
Labeler code: 69292
Product ID: 69292-571_616a890a-5d6d-448b-a6d0-24759f601731
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Risperidone
Dosage form: TABLET, ORALLY DISINTEGRATING
Route: ORAL
Labeler: Amici Pharma, Inc.
Application: ANDA077328
Marketing category: ANDA
Marketing start: 2026-04-01
Substance: RISPERIDONE
Active strength: .5 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 1.

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 · 205 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
2026-02-19 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…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077328-001	RISPERIDONE	0.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-02-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077328-002	RISPERIDONE	1MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-10-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077328-003	RISPERIDONE	2MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-02-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077328-004	RISPERIDONE	3MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-11-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077328-005	RISPERIDONE	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-11-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077328-001	RISPERIDONE	0.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-02-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077328-002	RISPERIDONE	1MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-10-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077328-003	RISPERIDONE	2MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-02-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077328-004	RISPERIDONE	3MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-11-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077328-005	RISPERIDONE	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-11-30	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 205 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
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…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077328-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077328-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077328-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077328-004	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077328-005	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077328-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077328-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077328-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077328-004	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077328-005	AB	1	`5bbf6a4d5a75…`

Additional Listing Data#

Finished product: Yes
Brand name base: Risperidone
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
RISPERIDONE	.5 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
ca41c144-224a-4d57-88d7-8778e6c69ed2	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69292-571-30	Risperidone	6 in 1 BLISTER PACK	TABLET, ORALLY DISINTEGRATING	6		1
69292-571-30	Risperidone	5 in 1 CARTON	TABLET, ORALLY DISINTEGRATING	5		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69292-571-30	EA - Each	69292-571	8011acf1-3575-409f-9144-a0207ab7655a	1	2026-05-22

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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 ndc (product): 69292-571

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
403825	risperiDONE 0.5 MG Disintegrating Oral Tablet	PSN	ca41c144-224a-4d57-88d7-8778e6c69ed2	1
401953	risperiDONE 1 MG Disintegrating Oral Tablet	PSN	ca41c144-224a-4d57-88d7-8778e6c69ed2	1
401954	risperiDONE 2 MG Disintegrating Oral Tablet	PSN	ca41c144-224a-4d57-88d7-8778e6c69ed2	1
616698	risperiDONE 3 MG Disintegrating Oral Tablet	PSN	ca41c144-224a-4d57-88d7-8778e6c69ed2	1
616705	risperiDONE 4 MG Disintegrating Oral Tablet	PSN	ca41c144-224a-4d57-88d7-8778e6c69ed2	1
403825	risperidone 0.5 MG Disintegrating Oral Tablet	SCD	ca41c144-224a-4d57-88d7-8778e6c69ed2	1
401953	risperidone 1 MG Disintegrating Oral Tablet	SCD	ca41c144-224a-4d57-88d7-8778e6c69ed2	1
401954	risperidone 2 MG Disintegrating Oral Tablet	SCD	ca41c144-224a-4d57-88d7-8778e6c69ed2	1
616698	risperidone 3 MG Disintegrating Oral Tablet	SCD	ca41c144-224a-4d57-88d7-8778e6c69ed2	1
616705	risperidone 4 MG Disintegrating Oral Tablet	SCD	ca41c144-224a-4d57-88d7-8778e6c69ed2	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
69292-571-30	69292057130	5 BLISTER PACK in 1 CARTON (69292-571-30) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK	5 blister pack	2026-04-01	No	No	Current