risperidone

Product NDC: 58118-0077
Requested package NDC: 58118-0077-8
11-digit product format: 581180077
Labeler code: 58118
Product ID: 58118-0077_b0269c97-f38b-4da4-e053-2a95a90a0b52
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: risperidone
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Clinical Solutions Wholesale, LLC
Application: ANDA078040
Marketing category: ANDA
Marketing start: 2008-11-13
Marketing end: 0000-00-00
Substance: RISPERIDONE
Active strength: 1 mg/1
Pharmacologic classes: Atypical Antipsychotic [EPC]
NDC exclude flag: No
Listing certified through: 2021-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	58118-0077	58118-0077-8	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 · 15 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…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`

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	TE codes	Approval date
A078040-001	RISPERIDONE	RISPERIDONE	0.25MG	TABLET / ORAL	AB	2008-10-16
A078040-002	RISPERIDONE	RISPERIDONE	0.5MG	TABLET / ORAL	AB	2008-10-16
A078040-003	RISPERIDONE	RISPERIDONE	1MG	TABLET / ORAL	AB	2008-10-16
A078040-004	RISPERIDONE	RISPERIDONE	2MG	TABLET / ORAL	AB	2008-10-16
A078040-005	RISPERIDONE	RISPERIDONE	3MG	TABLET / ORAL	AB	2008-10-16
A078040-006	RISPERIDONE	RISPERIDONE	4MG	TABLET / ORAL	AB	2008-10-16

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 6 matching rows.

Application-product, TE code table
Application-product	TE code
A078040-001	AB
A078040-002	AB
A078040-003	AB
A078040-004	AB
A078040-005	AB
A078040-006	AB

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	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A078040-001	RISPERIDONE	0.25MG	TABLET / ORAL	AB	2008-10-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078040-002	RISPERIDONE	0.5MG	TABLET / ORAL	AB	2008-10-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078040-003	RISPERIDONE	1MG	TABLET / ORAL	AB	2008-10-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078040-004	RISPERIDONE	2MG	TABLET / ORAL	AB	2008-10-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078040-005	RISPERIDONE	3MG	TABLET / ORAL	AB	2008-10-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078040-006	RISPERIDONE	4MG	TABLET / ORAL	AB	2008-10-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078040-001	RISPERIDONE	0.25MG	TABLET / ORAL	AB	2008-10-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078040-002	RISPERIDONE	0.5MG	TABLET / ORAL	AB	2008-10-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078040-003	RISPERIDONE	1MG	TABLET / ORAL	AB	2008-10-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078040-004	RISPERIDONE	2MG	TABLET / ORAL	AB	2008-10-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078040-005	RISPERIDONE	3MG	TABLET / ORAL	AB	2008-10-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078040-006	RISPERIDONE	4MG	TABLET / ORAL	AB	2008-10-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078040-001	RISPERIDONE	0.25MG	TABLET / ORAL	AB	2008-10-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078040-002	RISPERIDONE	0.5MG	TABLET / ORAL	AB	2008-10-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078040-003	RISPERIDONE	1MG	TABLET / ORAL	AB	2008-10-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078040-004	RISPERIDONE	2MG	TABLET / ORAL	AB	2008-10-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078040-005	RISPERIDONE	3MG	TABLET / ORAL	AB	2008-10-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078040-006	RISPERIDONE	4MG	TABLET / ORAL	AB	2008-10-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078040-001	RISPERIDONE	0.25MG	TABLET / ORAL	AB	2008-10-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078040-002	RISPERIDONE	0.5MG	TABLET / ORAL	AB	2008-10-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078040-003	RISPERIDONE	1MG	TABLET / ORAL	AB	2008-10-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078040-004	RISPERIDONE	2MG	TABLET / ORAL	AB	2008-10-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078040-005	RISPERIDONE	3MG	TABLET / ORAL	AB	2008-10-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078040-006	RISPERIDONE	4MG	TABLET / ORAL	AB	2008-10-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078040-001	RISPERIDONE	0.25MG	TABLET / ORAL	AB	2008-10-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078040-002	RISPERIDONE	0.5MG	TABLET / ORAL	AB	2008-10-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078040-003	RISPERIDONE	1MG	TABLET / ORAL	AB	2008-10-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078040-004	RISPERIDONE	2MG	TABLET / ORAL	AB	2008-10-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078040-005	RISPERIDONE	3MG	TABLET / ORAL	AB	2008-10-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078040-006	RISPERIDONE	4MG	TABLET / ORAL	AB	2008-10-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078040-001	RISPERIDONE	0.25MG	TABLET / ORAL	AB	2008-10-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078040-002	RISPERIDONE	0.5MG	TABLET / ORAL	AB	2008-10-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078040-003	RISPERIDONE	1MG	TABLET / ORAL	AB	2008-10-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078040-004	RISPERIDONE	2MG	TABLET / ORAL	AB	2008-10-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078040-005	RISPERIDONE	3MG	TABLET / ORAL	AB	2008-10-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078040-006	RISPERIDONE	4MG	TABLET / ORAL	AB	2008-10-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078040-001	RISPERIDONE	0.25MG	TABLET / ORAL	AB	2008-10-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078040-002	RISPERIDONE	0.5MG	TABLET / ORAL	AB	2008-10-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078040-003	RISPERIDONE	1MG	TABLET / ORAL	AB	2008-10-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078040-004	RISPERIDONE	2MG	TABLET / ORAL	AB	2008-10-16	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 246 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A078040-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078040-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078040-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078040-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078040-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078040-006	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078040-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078040-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078040-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078040-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078040-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078040-006	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078040-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078040-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078040-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078040-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078040-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078040-006	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078040-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078040-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078040-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078040-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078040-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078040-006	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078040-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078040-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078040-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078040-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078040-005	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078040-006	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078040-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078040-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078040-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078040-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078040-005	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078040-006	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078040-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078040-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078040-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078040-004	AB	1	`2680178bc6a6…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
58118-0077-8	2024-01-30	C162847	48780-1	1030e365-107e-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use RISPERIDONE safely and effectively. See full prescribing information for RISPERIDONE. RISPERIDONE tablets USP, for oral use Initial U.S. Approval: 1993

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
RISPERIDONE	ACTIVE INGREDIENT	L6UH7ZF8HC	RISPERIDONE TABLET, FILM COATED [CLINICAL SOLUTIONS WHOLESALE, LLC]	1
RISPERIDONE	ACTIVE MOIETY	L6UH7ZF8HC	RISPERIDONE TABLET, FILM COATED [CLINICAL SOLUTIONS WHOLESALE, LLC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	RISPERIDONE TABLET, FILM COATED [CLINICAL SOLUTIONS WHOLESALE, LLC]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	RISPERIDONE TABLET, FILM COATED [CLINICAL SOLUTIONS WHOLESALE, LLC]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	RISPERIDONE TABLET, FILM COATED [CLINICAL SOLUTIONS WHOLESALE, LLC]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	RISPERIDONE TABLET, FILM COATED [CLINICAL SOLUTIONS WHOLESALE, LLC]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	RISPERIDONE TABLET, FILM COATED [CLINICAL SOLUTIONS WHOLESALE, LLC]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	RISPERIDONE TABLET, FILM COATED [CLINICAL SOLUTIONS WHOLESALE, LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	RISPERIDONE TABLET, FILM COATED [CLINICAL SOLUTIONS WHOLESALE, LLC]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	RISPERIDONE TABLET, FILM COATED [CLINICAL SOLUTIONS WHOLESALE, LLC]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	RISPERIDONE TABLET, FILM COATED [CLINICAL SOLUTIONS WHOLESALE, LLC]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	RISPERIDONE TABLET, FILM COATED [CLINICAL SOLUTIONS WHOLESALE, LLC]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	RISPERIDONE TABLET, FILM COATED [CLINICAL SOLUTIONS WHOLESALE, LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
58118-0077	RISPERIDONE TABLET, FILM COATED [CLINICAL SOLUTIONS WHOLESALE, LLC]	6	Legacy NDC	20200926_a5cf7d9a-0014-44df-b6b9-d6f54f541bb7.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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
risperidone	RISPERIDONE	Cardinal Health 107, LLC	3ce21196-4aa0-469b-8f04-6650b2c48cb5	2026-04-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078040 application number: ANDA078040
risperidone	RISPERIDONE	Major Pharmaceuticals	d5abd75f-7f4a-4a7d-b849-82fce88f5ff7	2026-01-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078040 application number: ANDA078040
Risperidone	RISPERIDONE	American Health Packaging	f11dae15-b057-4258-9229-3819d0c980fe	2025-11-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078040 application number: ANDA078040
risperidone	RISPERIDONE	Zydus Pharmaceuticals USA Inc.	713b5ac7-53d6-4139-8599-3028f789de4b	2025-06-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078040 application number: ANDA078040
risperidone	RISPERIDONE	Zydus Lifesciences Limited	23993d21-80bf-41c4-b57d-88a620173b6b	2024-08-12		Exact identifier application applno (ANDA): 078040 application number: ANDA078040
risperidone	RISPERIDONE	Proficient Rx LP	b611fe52-1787-47e6-8a6b-1999a4e4f22c	2021-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078040 application number: ANDA078040

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	Marketing start	Marketing end	Sample	Exclude flag	Status
58118-0077-8	58118007708	30 TABLET, FILM COATED in 1 BLISTER PACK (58118-0077-8)	2015-11-09	0000-00-00	No	No	Current