RISPERDAL

Product NDC: 50458-301
11-digit product format: 504580301
Labeler code: 50458
Product ID: 50458-301_ebac424e-3ee1-4b30-9bc5-739c8eb7f87f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: risperidone
Dosage form: TABLET
Route: ORAL
Labeler: Janssen Pharmaceuticals, Inc.
Application: NDA020272
Marketing category: NDA
Marketing start: 1993-12-29
Marketing end: 0000-00-00
Substance: RISPERIDONE
Active strength: 0 mg/1
Pharmacologic classes: Atypical Antipsychotic [EPC]
NDC exclude flag: No
Listing certified through: 2023-12-31
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	50458-301		D	Discontinued by firm	2026-10-28
excluded package	package	50458-301	50458-301-01	D	Discontinued by firm	2026-10-28
excluded package	package	50458-301	50458-301-04	D	Discontinued by firm	2026-10-28
excluded package	package	50458-301	50458-301-50	D	Discontinued by firm	2026-10-28

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 1 · 48 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	50458-301-04	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50458-301-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50458-301-50	`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	50458-301-04	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50458-301-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50458-301-50	`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	50458-301-04	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50458-301-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50458-301-50	`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	50458-301-04	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50458-301-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50458-301-50	`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	50458-301-04	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50458-301-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50458-301-50	`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	50458-301-04	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50458-301-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50458-301-50	`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	50458-301-04	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50458-301-01	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50458-301-50	`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	50458-301-04	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	50458-301-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	50458-301-50	`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	50458-301-04	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	50458-301-01	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	50458-301-50	`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	50458-301-04	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	50458-301-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	50458-301-50	`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	50458-301-04	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	50458-301-01	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	50458-301-50	`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	50458-301-04	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	50458-301-01	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	50458-301-50	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 7 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N020272-001	RISPERDAL	RISPERIDONE	1MG	TABLET / ORAL	AB	RLD, RS	1993-12-29
N020272-002	RISPERDAL	RISPERIDONE	2MG	TABLET / ORAL	AB	RLD	1993-12-29
N020272-003	RISPERDAL	RISPERIDONE	3MG	TABLET / ORAL	AB	RLD	1993-12-29
N020272-004	RISPERDAL	RISPERIDONE	4MG	TABLET / ORAL	AB	RLD	1993-12-29
N020272-005	RISPERDAL	RISPERIDONE	5MG	TABLET / ORAL			1993-12-29
N020272-007	RISPERDAL	RISPERIDONE	0.5MG	TABLET / ORAL	AB	RLD	1999-01-27
N020272-008	RISPERDAL	RISPERIDONE	0.25MG	TABLET / ORAL	AB	RLD	1999-05-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N020272-001	AB
N020272-002	AB
N020272-003	AB
N020272-004	AB
N020272-007	AB
N020272-008	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 8 · 308 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	N020272-001	RISPERDAL	1MG	TABLET / ORAL	AB	RLD, RS	1993-12-29	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N020272-002	RISPERDAL	2MG	TABLET / ORAL	AB	RLD	1993-12-29	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N020272-003	RISPERDAL	3MG	TABLET / ORAL	AB	RLD	1993-12-29	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N020272-004	RISPERDAL	4MG	TABLET / ORAL	AB	RLD	1993-12-29	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N020272-005	RISPERDAL	5MG	TABLET / ORAL			1993-12-29	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N020272-007	RISPERDAL	0.5MG	TABLET / ORAL	AB	RLD	1999-01-27	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N020272-008	RISPERDAL	0.25MG	TABLET / ORAL	AB	RLD	1999-05-10	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N020272-001	RISPERDAL	1MG	TABLET / ORAL	AB	RLD, RS	1993-12-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020272-002	RISPERDAL	2MG	TABLET / ORAL	AB	RLD	1993-12-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020272-003	RISPERDAL	3MG	TABLET / ORAL	AB	RLD	1993-12-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020272-004	RISPERDAL	4MG	TABLET / ORAL	AB	RLD	1993-12-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020272-005	RISPERDAL	5MG	TABLET / ORAL			1993-12-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020272-007	RISPERDAL	0.5MG	TABLET / ORAL	AB	RLD	1999-01-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020272-008	RISPERDAL	0.25MG	TABLET / ORAL	AB	RLD	1999-05-10	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N020272-001	RISPERDAL	1MG	TABLET / ORAL	AB	RLD, RS	1993-12-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020272-002	RISPERDAL	2MG	TABLET / ORAL	AB	RLD	1993-12-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020272-003	RISPERDAL	3MG	TABLET / ORAL	AB	RLD	1993-12-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020272-004	RISPERDAL	4MG	TABLET / ORAL	AB	RLD	1993-12-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020272-005	RISPERDAL	5MG	TABLET / ORAL			1993-12-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020272-007	RISPERDAL	0.5MG	TABLET / ORAL	AB	RLD	1999-01-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020272-008	RISPERDAL	0.25MG	TABLET / ORAL	AB	RLD	1999-05-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020272-001	RISPERDAL	1MG	TABLET / ORAL	AB	RLD, RS	1993-12-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020272-002	RISPERDAL	2MG	TABLET / ORAL	AB	RLD	1993-12-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020272-003	RISPERDAL	3MG	TABLET / ORAL	AB	RLD	1993-12-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020272-004	RISPERDAL	4MG	TABLET / ORAL	AB	RLD	1993-12-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020272-005	RISPERDAL	5MG	TABLET / ORAL			1993-12-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020272-007	RISPERDAL	0.5MG	TABLET / ORAL	AB	RLD	1999-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020272-008	RISPERDAL	0.25MG	TABLET / ORAL	AB	RLD	1999-05-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020272-001	RISPERDAL	1MG	TABLET / ORAL	AB	RLD, RS	1993-12-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020272-002	RISPERDAL	2MG	TABLET / ORAL	AB	RLD	1993-12-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020272-003	RISPERDAL	3MG	TABLET / ORAL	AB	RLD	1993-12-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020272-004	RISPERDAL	4MG	TABLET / ORAL	AB	RLD	1993-12-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020272-005	RISPERDAL	5MG	TABLET / ORAL			1993-12-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020272-007	RISPERDAL	0.5MG	TABLET / ORAL	AB	RLD	1999-01-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020272-008	RISPERDAL	0.25MG	TABLET / ORAL	AB	RLD	1999-05-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020272-001	RISPERDAL	1MG	TABLET / ORAL	AB	RLD, RS	1993-12-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020272-002	RISPERDAL	2MG	TABLET / ORAL	AB	RLD	1993-12-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020272-003	RISPERDAL	3MG	TABLET / ORAL	AB	RLD	1993-12-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020272-004	RISPERDAL	4MG	TABLET / ORAL	AB	RLD	1993-12-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020272-005	RISPERDAL	5MG	TABLET / ORAL			1993-12-29	`6a471c1ec25d…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 264 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	N020272-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N020272-002	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N020272-003	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N020272-004	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N020272-007	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N020272-008	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N020272-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020272-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020272-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020272-004	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020272-007	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020272-008	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N020272-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020272-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020272-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020272-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020272-007	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020272-008	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020272-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020272-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020272-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020272-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020272-007	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020272-008	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020272-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020272-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020272-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020272-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020272-007	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020272-008	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020272-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020272-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020272-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020272-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020272-007	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020272-008	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020272-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020272-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020272-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020272-004	AB	1	`fd3edfee7708…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50458-301-01	EA - Each	50458-301	48886b93-1124-4899-a6a7-9ae619fc0dbc	1	2012-07-24
50458-301-04	EA - Each	50458-301	ae3818d3-4592-4d68-ad71-f36c51203a6c	1	2012-07-24
50458-301-50	EA - Each	50458-301	6f045705-ee7d-4f0d-abe9-c389d1949f20	1	2012-07-24