Risperidone M-TAB

Product NDC: 50458-603
11-digit product format: 504580603
Labeler code: 50458
Product ID: 50458-603_3e524f1e-7ea8-11e8-83da-f59c9d46d017
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: risperidone
Dosage form: TABLET, ORALLY DISINTEGRATING
Route: ORAL
Labeler: Janssen Pharmaceutical, Inc.
Application: NDA021444
Marketing category: NDA
Marketing start: 2003-04-02
Marketing end: 0000-00-00
Substance: RISPERIDONE
Active strength: 2 mg/1
Pharmacologic classes: Atypical Antipsychotic [EPC]
NDC exclude flag: No
Listing certified through: 2020-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	50458-603		D	Discontinued by firm		2026-08-03
excluded package	package	50458-603	50458-603-28	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 · 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	50458-603-28	`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	50458-603-28	`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	50458-603-28	`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	50458-603-28	`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	50458-603-28	`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	50458-603-28	`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	50458-603-28	`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	50458-603-28	`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	50458-603-28	`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	50458-603-28	`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	50458-603-28	`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	50458-603-28	`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…`

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
50458-603-28	Risperidone M-TAB	7 in 1 BOX	TABLET, ORALLY DISINTEGRATING	7		33
50458-603-28	Risperidone M-TAB	4 in 1 BLISTER PACK	TABLET, ORALLY DISINTEGRATING	4		33

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50458-603-28	EA - Each	50458-603	c69ec553-462d-4335-bca3-430c897149bb	1	2012-07-24

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50458-603	RISPERIDONE TABLET RISPERIDONE SOLUTION RISPERIDONE M-TAB (RISPERIDONE) TABLET, ORALLY DISINTEGRATING [JANSSEN PHARMACEUTICAL, INC.]	32	Legacy NDC, 2 package rows	20250302_701e1cd8-2868-4d29-85a9-a2212c88165f.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Risperidone	RISPERIDONE	Janssen Pharmaceutical, Inc.	701e1cd8-2868-4d29-85a9-a2212c88165f	2026-06-12	Boxed warning, Warnings, Adverse reactions	Exact identifier ndc (product): 50458-603
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

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
403825	risperiDONE 0.5 MG Disintegrating Oral Tablet	PSN	701e1cd8-2868-4d29-85a9-a2212c88165f	33
312829	risperiDONE 0.5 MG Oral Tablet	PSN	701e1cd8-2868-4d29-85a9-a2212c88165f	33
401953	risperiDONE 1 MG Disintegrating Oral Tablet	PSN	701e1cd8-2868-4d29-85a9-a2212c88165f	33
199387	risperiDONE 1 MG in 1 mL Oral Solution	PSN	701e1cd8-2868-4d29-85a9-a2212c88165f	33
312830	risperiDONE 1 MG Oral Tablet	PSN	701e1cd8-2868-4d29-85a9-a2212c88165f	33
401954	risperiDONE 2 MG Disintegrating Oral Tablet	PSN	701e1cd8-2868-4d29-85a9-a2212c88165f	33
312831	risperiDONE 2 MG Oral Tablet	PSN	701e1cd8-2868-4d29-85a9-a2212c88165f	33
616698	risperiDONE 3 MG Disintegrating Oral Tablet	PSN	701e1cd8-2868-4d29-85a9-a2212c88165f	33
312832	risperiDONE 3 MG Oral Tablet	PSN	701e1cd8-2868-4d29-85a9-a2212c88165f	33
616705	risperiDONE 4 MG Disintegrating Oral Tablet	PSN	701e1cd8-2868-4d29-85a9-a2212c88165f	33
314211	risperiDONE 4 MG Oral Tablet	PSN	701e1cd8-2868-4d29-85a9-a2212c88165f	33
403825	risperidone 0.5 MG Disintegrating Oral Tablet	SCD	701e1cd8-2868-4d29-85a9-a2212c88165f	33
312829	risperidone 0.5 MG Oral Tablet	SCD	701e1cd8-2868-4d29-85a9-a2212c88165f	33
401953	risperidone 1 MG Disintegrating Oral Tablet	SCD	701e1cd8-2868-4d29-85a9-a2212c88165f	33
312830	risperidone 1 MG Oral Tablet	SCD	701e1cd8-2868-4d29-85a9-a2212c88165f	33
199387	risperidone 1 MG/ML Oral Solution	SCD	701e1cd8-2868-4d29-85a9-a2212c88165f	33
401954	risperidone 2 MG Disintegrating Oral Tablet	SCD	701e1cd8-2868-4d29-85a9-a2212c88165f	33
312831	risperidone 2 MG Oral Tablet	SCD	701e1cd8-2868-4d29-85a9-a2212c88165f	33
616698	risperidone 3 MG Disintegrating Oral Tablet	SCD	701e1cd8-2868-4d29-85a9-a2212c88165f	33
312832	risperidone 3 MG Oral Tablet	SCD	701e1cd8-2868-4d29-85a9-a2212c88165f	33
616705	risperidone 4 MG Disintegrating Oral Tablet	SCD	701e1cd8-2868-4d29-85a9-a2212c88165f	33
314211	risperidone 4 MG Oral Tablet	SCD	701e1cd8-2868-4d29-85a9-a2212c88165f	33
199387	risperidone 1 MG per 1 ML Oral Solution	SY	701e1cd8-2868-4d29-85a9-a2212c88165f	33

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
50458-603-28	50458060328	7 in 1 BOX	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Risperidone	Janssen Pharmaceutical, Inc. \| Janssen Pharmaceutica, N.V. \| Janssen Pharmaceutica, N.V. (Geel) \| Janssen Ortho, LLC \| Janssen Pharmaceutical Sciences Unlimited Company	2026-06-12	HUMAN PRESCRIPTION DRUG LABEL	34