Risperidone

Product NDC: 58165-031
11-digit product format: 581650031
Labeler code: 58165
Product ID: 58165-031_45bc21f6-150d-e5e0-4d8d-a00d890a161e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Risperidone
Dosage form: TABLET, COATED
Route: ORAL
Labeler: Ratiopharm Inc
Application: ANDA077784
Marketing category: ANDA
Marketing start: 2010-06-08
Marketing end: 0000-00-00
Substance: RISPERIDONE
Active strength: 2 mg/1
Pharmacologic classes: Atypical Antipsychotic [EPC]
NDC exclude flag: E
Listing certified through: 2017-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	58165-031		I	Inactivated by FDA	2026-10-05
excluded package	package	58165-031	58165-031-01	I	Inactivated by FDA	2026-10-05
excluded package	package	58165-031	58165-031-02	I	Inactivated by FDA	2026-10-05
excluded package	package	58165-031	58165-031-03	I	Inactivated by FDA	2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 2 · 88 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	58165-031-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	58165-031-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	58165-031-03	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	58165-031-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	58165-031-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	58165-031-03	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	58165-031-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	58165-031-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	58165-031-03	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	58165-031-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	58165-031-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	58165-031-03	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	58165-031-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	58165-031-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	58165-031-03	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	58165-031-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	58165-031-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	58165-031-03	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	58165-031-02	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	58165-031-01	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	58165-031-03	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	58165-031-02	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	58165-031-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	58165-031-03	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	58165-031-02	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	58165-031-01	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	58165-031-03	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	58165-031-02	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	58165-031-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	58165-031-03	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	58165-031-02	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	58165-031-01	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	58165-031-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	58165-031-02	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	58165-031-01	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	58165-031-03	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	58165-031-02	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	58165-031-01	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	58165-031-03	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	58165-031-02	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	58165-031-01	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	58165-031-03	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	58165-031-02	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	58165-031-01	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	58165-031-03	`1332a3947898…`	`d4bfe170f9cd…`

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	Approval date
A077784-001	RISPERIDONE	RISPERIDONE	0.25MG	TABLET / ORAL	2010-06-08
A077784-002	RISPERIDONE	RISPERIDONE	0.5MG	TABLET / ORAL	2010-06-08
A077784-003	RISPERIDONE	RISPERIDONE	1MG	TABLET / ORAL	2010-06-08
A077784-004	RISPERIDONE	RISPERIDONE	2MG	TABLET / ORAL	2010-06-08
A077784-005	RISPERIDONE	RISPERIDONE	3MG	TABLET / ORAL	2010-06-08
A077784-006	RISPERIDONE	RISPERIDONE	4MG	TABLET / ORAL	2010-06-08

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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A077784-001	RISPERIDONE	0.25MG	TABLET / ORAL	2010-06-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077784-002	RISPERIDONE	0.5MG	TABLET / ORAL	2010-06-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077784-003	RISPERIDONE	1MG	TABLET / ORAL	2010-06-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077784-004	RISPERIDONE	2MG	TABLET / ORAL	2010-06-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077784-005	RISPERIDONE	3MG	TABLET / ORAL	2010-06-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077784-006	RISPERIDONE	4MG	TABLET / ORAL	2010-06-08	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077784-001	RISPERIDONE	0.25MG	TABLET / ORAL	2010-06-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077784-002	RISPERIDONE	0.5MG	TABLET / ORAL	2010-06-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077784-003	RISPERIDONE	1MG	TABLET / ORAL	2010-06-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077784-004	RISPERIDONE	2MG	TABLET / ORAL	2010-06-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077784-005	RISPERIDONE	3MG	TABLET / ORAL	2010-06-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077784-006	RISPERIDONE	4MG	TABLET / ORAL	2010-06-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077784-001	RISPERIDONE	0.25MG	TABLET / ORAL	2010-06-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077784-002	RISPERIDONE	0.5MG	TABLET / ORAL	2010-06-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077784-003	RISPERIDONE	1MG	TABLET / ORAL	2010-06-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077784-004	RISPERIDONE	2MG	TABLET / ORAL	2010-06-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077784-005	RISPERIDONE	3MG	TABLET / ORAL	2010-06-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077784-006	RISPERIDONE	4MG	TABLET / ORAL	2010-06-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077784-001	RISPERIDONE	0.25MG	TABLET / ORAL	2010-06-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077784-002	RISPERIDONE	0.5MG	TABLET / ORAL	2010-06-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077784-003	RISPERIDONE	1MG	TABLET / ORAL	2010-06-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077784-004	RISPERIDONE	2MG	TABLET / ORAL	2010-06-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077784-005	RISPERIDONE	3MG	TABLET / ORAL	2010-06-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077784-006	RISPERIDONE	4MG	TABLET / ORAL	2010-06-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077784-001	RISPERIDONE	0.25MG	TABLET / ORAL	2010-06-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077784-002	RISPERIDONE	0.5MG	TABLET / ORAL	2010-06-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077784-003	RISPERIDONE	1MG	TABLET / ORAL	2010-06-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077784-004	RISPERIDONE	2MG	TABLET / ORAL	2010-06-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077784-005	RISPERIDONE	3MG	TABLET / ORAL	2010-06-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077784-006	RISPERIDONE	4MG	TABLET / ORAL	2010-06-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077784-001	RISPERIDONE	0.25MG	TABLET / ORAL	2010-06-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077784-002	RISPERIDONE	0.5MG	TABLET / ORAL	2010-06-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077784-003	RISPERIDONE	1MG	TABLET / ORAL	2010-06-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077784-004	RISPERIDONE	2MG	TABLET / ORAL	2010-06-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077784-005	RISPERIDONE	3MG	TABLET / ORAL	2010-06-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077784-006	RISPERIDONE	4MG	TABLET / ORAL	2010-06-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077784-001	RISPERIDONE	0.25MG	TABLET / ORAL	2010-06-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077784-002	RISPERIDONE	0.5MG	TABLET / ORAL	2010-06-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077784-003	RISPERIDONE	1MG	TABLET / ORAL	2010-06-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077784-004	RISPERIDONE	2MG	TABLET / ORAL	2010-06-08	`b8a1b40f171c…`

Reported adverse events (FAERS/openFDA)#

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

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
58165-031-01	2019-10-21	C162847	48780-1	956f9ecf-c8c7-621f-e053-dbdaa90a74ad	These highlights do not include all the information needed to use RISPERIDONE safely and effectively. See full prescribing information for RISPERIDONE. RISPERIDONE tablets Initial U.S. Approval 1993
58165-031-02	2019-10-21	C162847	48780-1	956f9ecf-c8c7-621f-e053-dbdaa90a74ad	These highlights do not include all the information needed to use RISPERIDONE safely and effectively. See full prescribing information for RISPERIDONE. RISPERIDONE tablets Initial U.S. Approval 1993
58165-031-03	2019-10-21	C162847	48780-1	956f9ecf-c8c7-621f-e053-dbdaa90a74ad	These highlights do not include all the information needed to use RISPERIDONE safely and effectively. See full prescribing information for RISPERIDONE. RISPERIDONE tablets Initial U.S. Approval 1993

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
58165-031-01	Risperidone	100 in 1 BOTTLE	TABLET, COATED	100	1
58165-031-02	Risperidone	500 in 1 BOTTLE	TABLET, COATED	500	1
58165-031-03	Risperidone	150 in 1 BLISTER PACK	TABLET, COATED	150	1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
Risperidone	ACTIVE INGREDIENT	L6UH7ZF8HC	RISPERIDONE (RISPERIDONE) TABLET, COATED [RATIOPHARM INC]	1
Risperidone	ACTIVE MOIETY	L6UH7ZF8HC	RISPERIDONE (RISPERIDONE) TABLET, COATED [RATIOPHARM INC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
58165-031	RISPERIDONE (RISPERIDONE) TABLET, COATED [RATIOPHARM INC]	1	Legacy NDC, 3 package rows	20100625_c0c3eeb6-8a75-0b20-2008-396e63cddcdb.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	c0c3eeb6-8a75-0b20-2008-396e63cddcdb	1
312829	risperiDONE 0.5 MG Oral Tablet	PSN	c0c3eeb6-8a75-0b20-2008-396e63cddcdb	1
312830	risperiDONE 1 MG Oral Tablet	PSN	c0c3eeb6-8a75-0b20-2008-396e63cddcdb	1
312831	risperiDONE 2 MG Oral Tablet	PSN	c0c3eeb6-8a75-0b20-2008-396e63cddcdb	1
312832	risperiDONE 3 MG Oral Tablet	PSN	c0c3eeb6-8a75-0b20-2008-396e63cddcdb	1
314211	risperiDONE 4 MG Oral Tablet	PSN	c0c3eeb6-8a75-0b20-2008-396e63cddcdb	1
312828	risperidone 0.25 MG Oral Tablet	SCD	c0c3eeb6-8a75-0b20-2008-396e63cddcdb	1
312829	risperidone 0.5 MG Oral Tablet	SCD	c0c3eeb6-8a75-0b20-2008-396e63cddcdb	1
312830	risperidone 1 MG Oral Tablet	SCD	c0c3eeb6-8a75-0b20-2008-396e63cddcdb	1
312831	risperidone 2 MG Oral Tablet	SCD	c0c3eeb6-8a75-0b20-2008-396e63cddcdb	1
312832	risperidone 3 MG Oral Tablet	SCD	c0c3eeb6-8a75-0b20-2008-396e63cddcdb	1
314211	risperidone 4 MG Oral Tablet	SCD	c0c3eeb6-8a75-0b20-2008-396e63cddcdb	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
58165-031-01	58165003101	100 in 1 BOTTLE	Historical
58165-031-02	58165003102	500 in 1 BOTTLE	Historical
58165-031-03	58165003103	150 in 1 BLISTER PACK	Historical