Risperidone

Product NDC: 51079-465
11-digit product format: 510790465
Labeler code: 51079
Product ID: 51079-465_a3690b28-f570-7141-e053-2995a90a1b65
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: risperidone
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Mylan Institutional Inc.
Application: ANDA076288
Marketing category: ANDA
Marketing start: 2008-10-06
Marketing end: 2020-09-30
Substance: RISPERIDONE
Active strength: 4 mg/1
Pharmacologic classes: Atypical Antipsychotic [EPC]
NDC exclude flag: No
Listing certified through: 0000-00-00
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	51079-465		D	Discontinued by firm		2026-08-03
excluded package	package	51079-465	51079-465-20	D	Discontinued by firm		2026-08-03

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 · 24 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	51079-465-20	`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	51079-465-20	`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	51079-465-20	`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	51079-465-20	`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	51079-465-20	`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	51079-465-20	`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	51079-465-20	`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	51079-465-20	`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	51079-465-20	`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	51079-465-20	`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	51079-465-20	`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	51079-465-20	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A076288-001	RISPERIDONE	RISPERIDONE	0.25MG	TABLET / ORAL	2008-09-15
A076288-002	RISPERIDONE	RISPERIDONE	0.5MG	TABLET / ORAL	2008-09-15
A076288-003	RISPERIDONE	RISPERIDONE	1MG	TABLET / ORAL	2008-09-15
A076288-004	RISPERIDONE	RISPERIDONE	2MG	TABLET / ORAL	2008-09-15
A076288-005	RISPERIDONE	RISPERIDONE	3MG	TABLET / ORAL	2008-09-15
A076288-006	RISPERIDONE	RISPERIDONE	4MG	TABLET / ORAL	2008-09-15

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 · 246 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A076288-001	RISPERIDONE	0.25MG	TABLET / ORAL	2008-09-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076288-002	RISPERIDONE	0.5MG	TABLET / ORAL	2008-09-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076288-003	RISPERIDONE	1MG	TABLET / ORAL	2008-09-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076288-004	RISPERIDONE	2MG	TABLET / ORAL	2008-09-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076288-005	RISPERIDONE	3MG	TABLET / ORAL	2008-09-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076288-006	RISPERIDONE	4MG	TABLET / ORAL	2008-09-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076288-001	RISPERIDONE	0.25MG	TABLET / ORAL	2008-09-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076288-002	RISPERIDONE	0.5MG	TABLET / ORAL	2008-09-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076288-003	RISPERIDONE	1MG	TABLET / ORAL	2008-09-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076288-004	RISPERIDONE	2MG	TABLET / ORAL	2008-09-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076288-005	RISPERIDONE	3MG	TABLET / ORAL	2008-09-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076288-006	RISPERIDONE	4MG	TABLET / ORAL	2008-09-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076288-001	RISPERIDONE	0.25MG	TABLET / ORAL	2008-09-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076288-002	RISPERIDONE	0.5MG	TABLET / ORAL	2008-09-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076288-003	RISPERIDONE	1MG	TABLET / ORAL	2008-09-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076288-004	RISPERIDONE	2MG	TABLET / ORAL	2008-09-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076288-005	RISPERIDONE	3MG	TABLET / ORAL	2008-09-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076288-006	RISPERIDONE	4MG	TABLET / ORAL	2008-09-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076288-001	RISPERIDONE	0.25MG	TABLET / ORAL	2008-09-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076288-002	RISPERIDONE	0.5MG	TABLET / ORAL	2008-09-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076288-003	RISPERIDONE	1MG	TABLET / ORAL	2008-09-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076288-004	RISPERIDONE	2MG	TABLET / ORAL	2008-09-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076288-005	RISPERIDONE	3MG	TABLET / ORAL	2008-09-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076288-006	RISPERIDONE	4MG	TABLET / ORAL	2008-09-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076288-001	RISPERIDONE	0.25MG	TABLET / ORAL	2008-09-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076288-002	RISPERIDONE	0.5MG	TABLET / ORAL	2008-09-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076288-003	RISPERIDONE	1MG	TABLET / ORAL	2008-09-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076288-004	RISPERIDONE	2MG	TABLET / ORAL	2008-09-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076288-005	RISPERIDONE	3MG	TABLET / ORAL	2008-09-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076288-006	RISPERIDONE	4MG	TABLET / ORAL	2008-09-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076288-001	RISPERIDONE	0.25MG	TABLET / ORAL	2008-09-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076288-002	RISPERIDONE	0.5MG	TABLET / ORAL	2008-09-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076288-003	RISPERIDONE	1MG	TABLET / ORAL	2008-09-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076288-004	RISPERIDONE	2MG	TABLET / ORAL	2008-09-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076288-005	RISPERIDONE	3MG	TABLET / ORAL	2008-09-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076288-006	RISPERIDONE	4MG	TABLET / ORAL	2008-09-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076288-001	RISPERIDONE	0.25MG	TABLET / ORAL	2008-09-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076288-002	RISPERIDONE	0.5MG	TABLET / ORAL	2008-09-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076288-003	RISPERIDONE	1MG	TABLET / ORAL	2008-09-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076288-004	RISPERIDONE	2MG	TABLET / ORAL	2008-09-15	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A076288-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076288-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076288-003	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076288-004	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076288-005	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076288-006	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A076288-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A076288-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A076288-003	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A076288-004	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A076288-005	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A076288-006	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076288-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A076288-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A076288-003	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A076288-004	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A076288-005	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A076288-006	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076288-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A076288-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A076288-003	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A076288-004	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A076288-005	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A076288-006	AB	1	`ea99ee380514…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
51079-465-01	EA - Each	51079-465	a33c8ffd-581a-4676-b93c-e2624373894f	1	2012-07-24
51079-465-20	EA - Each	51079-465	c63b0463-3964-448f-b6d3-799eb7966766	1	2012-07-24
51079-465-30	EA - Each	51079-465	8e59937a-0733-4496-9018-1d09aeffb0e3	1	2012-07-24
51079-465-56	EA - Each	51079-465	d0327c1f-c473-48f1-a3fb-442f55a68c82	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
RISPERIDONE	ACTIVE INGREDIENT	L6UH7ZF8HC	RISPERIDONE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	4
RISPERIDONE	ACTIVE MOIETY	L6UH7ZF8HC	RISPERIDONE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	4
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	RISPERIDONE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	4
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	RISPERIDONE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	4
DOCUSATE SODIUM	INACTIVE INGREDIENT	F05Q2T2JA0	RISPERIDONE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	4
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	RISPERIDONE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	4
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	RISPERIDONE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	4
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	RISPERIDONE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	4
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	RISPERIDONE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	RISPERIDONE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	4
POLYDEXTROSE	INACTIVE INGREDIENT	VH2XOU12IE	RISPERIDONE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	4
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	RISPERIDONE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	4
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	RISPERIDONE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	4
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	RISPERIDONE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	4
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	RISPERIDONE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	4
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	RISPERIDONE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	4
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	RISPERIDONE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	4