RISPERDAL M-TAB

Product NDC: 50458-355
11-digit product format: 504580355
Labeler code: 50458
Product ID: 50458-355_43556c05-69ec-1276-e063-6294a90a968e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: risperidone
Dosage form: TABLET, ORALLY DISINTEGRATING
Route: ORAL
Labeler: Janssen Pharmaceuticals, Inc.
Application: NDA021444
Marketing category: NDA
Marketing start: 2003-04-02
Substance: RISPERIDONE
Active strength: 4 mg/1
Pharmacologic classes: Atypical Antipsychotic [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	50458-355	50458-355-28	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 · 12 matching rows.

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

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

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	RLD / RS	Approval date
N021444-001	RISPERDAL	RISPERIDONE	0.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2003-04-02
N021444-002	RISPERDAL	RISPERIDONE	1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2003-04-02
N021444-003	RISPERDAL	RISPERIDONE	2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2003-04-02
N021444-004	RISPERDAL	RISPERIDONE	3MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2004-12-23
N021444-005	RISPERDAL	RISPERIDONE	4MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2004-12-23

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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021444-001	RISPERDAL	0.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2003-04-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021444-002	RISPERDAL	1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2003-04-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021444-003	RISPERDAL	2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2003-04-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021444-004	RISPERDAL	3MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2004-12-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021444-005	RISPERDAL	4MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2004-12-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021444-001	RISPERDAL	0.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2003-04-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021444-002	RISPERDAL	1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2003-04-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021444-003	RISPERDAL	2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2003-04-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021444-004	RISPERDAL	3MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2004-12-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021444-005	RISPERDAL	4MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2004-12-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021444-001	RISPERDAL	0.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2003-04-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021444-002	RISPERDAL	1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2003-04-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021444-003	RISPERDAL	2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2003-04-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021444-004	RISPERDAL	3MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2004-12-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021444-005	RISPERDAL	4MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2004-12-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021444-001	RISPERDAL	0.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2003-04-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021444-002	RISPERDAL	1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2003-04-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021444-003	RISPERDAL	2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2003-04-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021444-004	RISPERDAL	3MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2004-12-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021444-005	RISPERDAL	4MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2004-12-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021444-001	RISPERDAL	0.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2003-04-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021444-002	RISPERDAL	1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2003-04-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021444-003	RISPERDAL	2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2003-04-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021444-004	RISPERDAL	3MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2004-12-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021444-005	RISPERDAL	4MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2004-12-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021444-001	RISPERDAL	0.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2003-04-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021444-002	RISPERDAL	1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2003-04-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021444-003	RISPERDAL	2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2003-04-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021444-004	RISPERDAL	3MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2004-12-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021444-005	RISPERDAL	4MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2004-12-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021444-001	RISPERDAL	0.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2003-04-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021444-002	RISPERDAL	1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2003-04-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021444-003	RISPERDAL	2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2003-04-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021444-004	RISPERDAL	3MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2004-12-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021444-005	RISPERDAL	4MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2004-12-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021444-001	RISPERDAL	0.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2003-04-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021444-002	RISPERDAL	1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2003-04-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021444-003	RISPERDAL	2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2003-04-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021444-004	RISPERDAL	3MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2004-12-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021444-005	RISPERDAL	4MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2004-12-23	`5bbf6a4d5a75…`

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	N021444-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021444-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021444-003	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021444-004	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021444-005	AB	1	`74a2ff9319b5…`
2021-03-12 10:30 UTC	2021-03	N021444-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021444-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021444-003	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021444-004	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021444-005	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021444-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021444-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021444-003	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021444-004	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021444-005	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021444-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021444-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021444-003	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021444-004	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021444-005	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021444-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021444-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021444-003	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021444-004	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021444-005	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021444-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021444-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021444-003	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021444-004	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021444-005	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021444-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021444-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021444-003	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021444-004	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021444-005	AB	1	`ea99ee380514…`

Additional Listing Data#

Finished product: Yes
Brand name base: RISPERDAL M-TAB
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
RISPERIDONE	4 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 2 · 22 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
104781	Internal RxNorm lookup
104782	Internal RxNorm lookup
104783	Internal RxNorm lookup
104784	Internal RxNorm lookup
199387	Internal RxNorm lookup
211489	Internal RxNorm lookup
262222	Internal RxNorm lookup
312829	Internal RxNorm lookup
312830	Internal RxNorm lookup
312831	Internal RxNorm lookup
312832	Internal RxNorm lookup
314211	Internal RxNorm lookup
401953	Internal RxNorm lookup
401954	Internal RxNorm lookup
403825	Internal RxNorm lookup
616698	Internal RxNorm lookup
616705	Internal RxNorm lookup
630890	Internal RxNorm lookup
630974	Internal RxNorm lookup
806297	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
7e117c7e-02fc-4343-92a1-230061dfc5e0	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
c6f86816-7da6-43ea-8c25-ac9758311cc5	Product name	1	20220118
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50458-355-28	RISPERDAL M-TAB	7 in 1 BOX	TABLET, ORALLY DISINTEGRATING	7		42
50458-355-28	RISPERDAL M-TAB	4 in 1 BLISTER PACK	TABLET, ORALLY DISINTEGRATING	4		42

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50458-355-28	EA - Each	50458-355	f918d4e4-01b4-4f9a-ad2b-0d8566f5c3cc	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
risperidone	ACTIVE INGREDIENT	L6UH7ZF8HC	RISPERDAL (RISPERIDONE) TABLET RISPERDAL M-TAB (RISPERIDONE) TABLET, ORALLY DISINTEGRATING RISPERDAL (RISPERIDONE) SOLUTION [JANSSEN PHARMACEUTICALS, INC.]	15
risperidone	ACTIVE MOIETY	L6UH7ZF8HC	RISPERDAL (RISPERIDONE) TABLET RISPERDAL M-TAB (RISPERIDONE) TABLET, ORALLY DISINTEGRATING RISPERDAL (RISPERIDONE) SOLUTION [JANSSEN PHARMACEUTICALS, INC.]	15
Aluminum Oxide	INACTIVE INGREDIENT	LMI26O6933	RISPERDAL (RISPERIDONE) TABLET RISPERDAL M-TAB (RISPERIDONE) TABLET, ORALLY DISINTEGRATING RISPERDAL (RISPERIDONE) SOLUTION [JANSSEN PHARMACEUTICALS, INC.]	15
anhydrous lactose	INACTIVE INGREDIENT	3SY5LH9PMK	RISPERDAL (RISPERIDONE) TABLET RISPERDAL M-TAB (RISPERIDONE) TABLET, ORALLY DISINTEGRATING RISPERDAL (RISPERIDONE) SOLUTION [JANSSEN PHARMACEUTICALS, INC.]	15
aspartame	INACTIVE INGREDIENT	Z0H242BBR1	RISPERDAL (RISPERIDONE) TABLET RISPERDAL M-TAB (RISPERIDONE) TABLET, ORALLY DISINTEGRATING RISPERDAL (RISPERIDONE) SOLUTION [JANSSEN PHARMACEUTICALS, INC.]	15
benzoic acid	INACTIVE INGREDIENT	8SKN0B0MIM	RISPERDAL (RISPERIDONE) TABLET RISPERDAL M-TAB (RISPERIDONE) TABLET, ORALLY DISINTEGRATING RISPERDAL (RISPERIDONE) SOLUTION [JANSSEN PHARMACEUTICALS, INC.]	15
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)	INACTIVE INGREDIENT	4Q93RCW27E	RISPERDAL (RISPERIDONE) TABLET RISPERDAL M-TAB (RISPERIDONE) TABLET, ORALLY DISINTEGRATING RISPERDAL (RISPERIDONE) SOLUTION [JANSSEN PHARMACEUTICALS, INC.]	15
cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	RISPERDAL (RISPERIDONE) TABLET RISPERDAL M-TAB (RISPERIDONE) TABLET, ORALLY DISINTEGRATING RISPERDAL (RISPERIDONE) SOLUTION [JANSSEN PHARMACEUTICALS, INC.]	15
D&C Yellow No. 10	INACTIVE INGREDIENT	35SW5USQ3G	RISPERDAL (RISPERIDONE) TABLET RISPERDAL M-TAB (RISPERIDONE) TABLET, ORALLY DISINTEGRATING RISPERDAL (RISPERIDONE) SOLUTION [JANSSEN PHARMACEUTICALS, INC.]	15
FD&C Blue No. 2	INACTIVE INGREDIENT	L06K8R7DQK	RISPERDAL (RISPERIDONE) TABLET RISPERDAL M-TAB (RISPERIDONE) TABLET, ORALLY DISINTEGRATING RISPERDAL (RISPERIDONE) SOLUTION [JANSSEN PHARMACEUTICALS, INC.]	15
FD&C Yellow No. 6	INACTIVE INGREDIENT	H77VEI93A8	RISPERDAL (RISPERIDONE) TABLET RISPERDAL M-TAB (RISPERIDONE) TABLET, ORALLY DISINTEGRATING RISPERDAL (RISPERIDONE) SOLUTION [JANSSEN PHARMACEUTICALS, INC.]	15
ferric oxide red	INACTIVE INGREDIENT	1K09F3G675	RISPERDAL (RISPERIDONE) TABLET RISPERDAL M-TAB (RISPERIDONE) TABLET, ORALLY DISINTEGRATING RISPERDAL (RISPERIDONE) SOLUTION [JANSSEN PHARMACEUTICALS, INC.]	15
ferric oxide yellow	INACTIVE INGREDIENT	EX438O2MRT	RISPERDAL (RISPERIDONE) TABLET RISPERDAL M-TAB (RISPERIDONE) TABLET, ORALLY DISINTEGRATING RISPERDAL (RISPERIDONE) SOLUTION [JANSSEN PHARMACEUTICALS, INC.]	15
gelatin	INACTIVE INGREDIENT	2G86QN327L	RISPERDAL (RISPERIDONE) TABLET RISPERDAL M-TAB (RISPERIDONE) TABLET, ORALLY DISINTEGRATING RISPERDAL (RISPERIDONE) SOLUTION [JANSSEN PHARMACEUTICALS, INC.]	15
glycine	INACTIVE INGREDIENT	TE7660XO1C	RISPERDAL (RISPERIDONE) TABLET RISPERDAL M-TAB (RISPERIDONE) TABLET, ORALLY DISINTEGRATING RISPERDAL (RISPERIDONE) SOLUTION [JANSSEN PHARMACEUTICALS, INC.]	15
hypromelloses	INACTIVE INGREDIENT	3NXW29V3WO	RISPERDAL (RISPERIDONE) TABLET RISPERDAL M-TAB (RISPERIDONE) TABLET, ORALLY DISINTEGRATING RISPERDAL (RISPERIDONE) SOLUTION [JANSSEN PHARMACEUTICALS, INC.]	15
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	RISPERDAL (RISPERIDONE) TABLET RISPERDAL M-TAB (RISPERIDONE) TABLET, ORALLY DISINTEGRATING RISPERDAL (RISPERIDONE) SOLUTION [JANSSEN PHARMACEUTICALS, INC.]	15
mannitol	INACTIVE INGREDIENT	3OWL53L36A	RISPERDAL (RISPERIDONE) TABLET RISPERDAL M-TAB (RISPERIDONE) TABLET, ORALLY DISINTEGRATING RISPERDAL (RISPERIDONE) SOLUTION [JANSSEN PHARMACEUTICALS, INC.]	15
peppermint oil	INACTIVE INGREDIENT	AV092KU4JH	RISPERDAL (RISPERIDONE) TABLET RISPERDAL M-TAB (RISPERIDONE) TABLET, ORALLY DISINTEGRATING RISPERDAL (RISPERIDONE) SOLUTION [JANSSEN PHARMACEUTICALS, INC.]	15
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	RISPERDAL (RISPERIDONE) TABLET RISPERDAL M-TAB (RISPERIDONE) TABLET, ORALLY DISINTEGRATING RISPERDAL (RISPERIDONE) SOLUTION [JANSSEN PHARMACEUTICALS, INC.]	15
silicon dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	RISPERDAL (RISPERIDONE) TABLET RISPERDAL M-TAB (RISPERIDONE) TABLET, ORALLY DISINTEGRATING RISPERDAL (RISPERIDONE) SOLUTION [JANSSEN PHARMACEUTICALS, INC.]	15
sodium hydroxide	INACTIVE INGREDIENT	55X04QC32I	RISPERDAL (RISPERIDONE) TABLET RISPERDAL M-TAB (RISPERIDONE) TABLET, ORALLY DISINTEGRATING RISPERDAL (RISPERIDONE) SOLUTION [JANSSEN PHARMACEUTICALS, INC.]	15
sodium lauryl sulfate	INACTIVE INGREDIENT	368GB5141J	RISPERDAL (RISPERIDONE) TABLET RISPERDAL M-TAB (RISPERIDONE) TABLET, ORALLY DISINTEGRATING RISPERDAL (RISPERIDONE) SOLUTION [JANSSEN PHARMACEUTICALS, INC.]	15
starch, corn	INACTIVE INGREDIENT	O8232NY3SJ	RISPERDAL (RISPERIDONE) TABLET RISPERDAL M-TAB (RISPERIDONE) TABLET, ORALLY DISINTEGRATING RISPERDAL (RISPERIDONE) SOLUTION [JANSSEN PHARMACEUTICALS, INC.]	15
talc	INACTIVE INGREDIENT	7SEV7J4R1U	RISPERDAL (RISPERIDONE) TABLET RISPERDAL M-TAB (RISPERIDONE) TABLET, ORALLY DISINTEGRATING RISPERDAL (RISPERIDONE) SOLUTION [JANSSEN PHARMACEUTICALS, INC.]	15
tartaric acid	INACTIVE INGREDIENT	W4888I119H	RISPERDAL (RISPERIDONE) TABLET RISPERDAL M-TAB (RISPERIDONE) TABLET, ORALLY DISINTEGRATING RISPERDAL (RISPERIDONE) SOLUTION [JANSSEN PHARMACEUTICALS, INC.]	15
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	RISPERDAL (RISPERIDONE) TABLET RISPERDAL M-TAB (RISPERIDONE) TABLET, ORALLY DISINTEGRATING RISPERDAL (RISPERIDONE) SOLUTION [JANSSEN PHARMACEUTICALS, INC.]	15
water	INACTIVE INGREDIENT	059QF0KO0R	RISPERDAL (RISPERIDONE) TABLET RISPERDAL M-TAB (RISPERIDONE) TABLET, ORALLY DISINTEGRATING RISPERDAL (RISPERIDONE) SOLUTION [JANSSEN PHARMACEUTICALS, INC.]	15
xanthan gum	INACTIVE INGREDIENT	TTV12P4NEE	RISPERDAL (RISPERIDONE) TABLET RISPERDAL M-TAB (RISPERIDONE) TABLET, ORALLY DISINTEGRATING RISPERDAL (RISPERIDONE) SOLUTION [JANSSEN PHARMACEUTICALS, INC.]	15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50458-355	RISPERDAL (RISPERIDONE) TABLET RISPERDAL M-TAB (RISPERIDONE) TABLET, ORALLY DISINTEGRATING RISPERDAL (RISPERIDONE) SOLUTION [JANSSEN PHARMACEUTICALS, INC.]	40	Current NDC, Legacy NDC, 2 package rows	20250228_7e117c7e-02fc-4343-92a1-230061dfc5e0.zip

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
RISPERDAL	RISPERIDONE	Janssen Pharmaceuticals, Inc.	7e117c7e-02fc-4343-92a1-230061dfc5e0	2026-05-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021444 application number: NDA021444 ndc (product): 50458-355

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
L6UH7ZF8HC	RISPERIDONE	106266-06-2	RISPERIDONE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
50458-355-28	50458035528	7 in 1 BOX	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
RISPERDAL	Janssen Pharmaceuticals, Inc. \| Janssen Pharmaceutica, N.V \| Janssen Pharmaceutica, N.V. \| Janssen Ortho LLC \| Janssen Pharmaceutical Sciences Unlimited Company	2026-05-28	HUMAN PRESCRIPTION DRUG LABEL	43