Risperidone

Product NDC: 0378-3513
11-digit product format: 003783513
Labeler code: 0378
Product ID: 0378-3513_bd55c402-c772-4adf-a9cc-129ab7f67fee
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: risperidone
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Mylan Pharmaceuticals Inc.
Application: ANDA076288
Marketing category: ANDA
Marketing start: 2008-09-17
Marketing end: 2020-09-30
Substance: RISPERIDONE
Active strength: 3 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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	0378-3513		D	Discontinued by firm	2026-08-03
excluded package	package	0378-3513	0378-3513-05	D	Discontinued by firm	2026-08-03
excluded package	package	0378-3513	0378-3513-91	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 · 36 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	0378-3513-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0378-3513-91	`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	0378-3513-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0378-3513-91	`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	0378-3513-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0378-3513-91	`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	0378-3513-05	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0378-3513-91	`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	0378-3513-05	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0378-3513-91	`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	0378-3513-05	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0378-3513-91	`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	0378-3513-05	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0378-3513-91	`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	0378-3513-05	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0378-3513-91	`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	0378-3513-05	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0378-3513-91	`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	0378-3513-05	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0378-3513-91	`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	0378-3513-05	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0378-3513-91	`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	0378-3513-05	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0378-3513-91	`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 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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0378-3513-05	EA - Each	0378-3513	394fd0b8-270f-4625-a999-31ae09a8201f	1	2012-07-24
0378-3513-91	EA - Each	0378-3513	dbef1ea5-d3c8-4f85-b6b5-57bb48db4b6d	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 PHARMACEUTICALS INC.]	8
RISPERIDONE	ACTIVE MOIETY	L6UH7ZF8HC	RISPERIDONE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	8
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	RISPERIDONE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	8
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	RISPERIDONE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	8
DOCUSATE SODIUM	INACTIVE INGREDIENT	F05Q2T2JA0	RISPERIDONE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	8
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	RISPERIDONE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	8
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	RISPERIDONE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	8
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	RISPERIDONE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	8
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	RISPERIDONE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	8
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	RISPERIDONE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	8
POLYDEXTROSE	INACTIVE INGREDIENT	VH2XOU12IE	RISPERIDONE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	8
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	RISPERIDONE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	8
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	RISPERIDONE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	8
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	RISPERIDONE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	8
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	RISPERIDONE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	8
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	RISPERIDONE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	8
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	RISPERIDONE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	8
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
RISPERIDONE	ACTIVE INGREDIENT	L6UH7ZF8HC	RISPERIDONE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	3
RISPERIDONE	ACTIVE MOIETY	L6UH7ZF8HC	RISPERIDONE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	RISPERIDONE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	3
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	RISPERIDONE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	3
DOCUSATE SODIUM	INACTIVE INGREDIENT	F05Q2T2JA0	RISPERIDONE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	3
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	RISPERIDONE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	3
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	RISPERIDONE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	3
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	RISPERIDONE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	3
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	RISPERIDONE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	RISPERIDONE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	3
POLYDEXTROSE	INACTIVE INGREDIENT	VH2XOU12IE	RISPERIDONE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	3
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	RISPERIDONE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	3
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	RISPERIDONE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	3
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	RISPERIDONE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	3
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	RISPERIDONE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	RISPERIDONE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	3
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	RISPERIDONE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	3

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
312830	risperiDONE 1 MG Oral Tablet	PSN	50aec836-fbfd-49af-9448-912b8279a7f9	3
312831	risperiDONE 2 MG Oral Tablet	PSN	50aec836-fbfd-49af-9448-912b8279a7f9	3
312832	risperiDONE 3 MG Oral Tablet	PSN	50aec836-fbfd-49af-9448-912b8279a7f9	3
314211	risperiDONE 4 MG Oral Tablet	PSN	50aec836-fbfd-49af-9448-912b8279a7f9	3
312830	risperidone 1 MG Oral Tablet	SCD	50aec836-fbfd-49af-9448-912b8279a7f9	3
312831	risperidone 2 MG Oral Tablet	SCD	50aec836-fbfd-49af-9448-912b8279a7f9	3
312832	risperidone 3 MG Oral Tablet	SCD	50aec836-fbfd-49af-9448-912b8279a7f9	3
314211	risperidone 4 MG Oral Tablet	SCD	50aec836-fbfd-49af-9448-912b8279a7f9	3

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Risperidone	Mylan Institutional Inc.	2020-04-16	HUMAN PRESCRIPTION DRUG LABEL	12
Risperidone	Mylan Pharmaceuticals Inc.	2020-02-17	HUMAN PRESCRIPTION DRUG LABEL	16
Risperidone	Aphena Pharma Solutions - Tennessee, LLC	2014-05-07	HUMAN PRESCRIPTION DRUG LABEL	3