RISPERDAL M-TAB

Product NDC: 50458-325
11-digit product format: 504580325
Labeler code: 50458
Product ID: 50458-325_b7f7983b-0d54-4910-9399-5b83d218bd74
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: 2 mg/1
Pharmacologic classes: Atypical Antipsychotic [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
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	50458-325	50458-325-28	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 · 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 44.

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 · 220 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	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	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	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	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	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	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	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	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	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	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	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	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	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	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	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	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	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	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	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	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	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	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	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	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	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	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	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	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	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	`caaa826d4ba7…`
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…`

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…`

Reported adverse events (FAERS/openFDA)#

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

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	2 mg/1

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
50458-325-28	RISPERDAL M-TAB	7 in 1 BOX	TABLET, ORALLY DISINTEGRATING	7		42
50458-325-28	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
50458-325-28	EA - Each	50458-325	0eb5aad1-080b-4e85-8c2c-b018dc632002	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
50458-325	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

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
50458-325-28	50458032528	7 in 1 BOX	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
RISPERDAL	Janssen Pharmaceuticals, Inc. \| Janssen Pharmaceutica NV \| Janssen Ortho LLC \| Janssen Pharmaceutical Sciences Unlimited Company \| LUSOMEDICAMENTA - SOCIEDADE TÉCNICA FARMACÊUTICA, S.A.	2026-10-23	HUMAN PRESCRIPTION DRUG LABEL	46