Risperidone

Product NDC: 0904-6358
Requested package NDC: 0904-6358-61
11-digit product format: 009046358
Labeler code: 0904
Product ID: 0904-6358_f68fdc24-2093-4ac8-9a03-5f03f5bf0b8a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Risperidone
Dosage form: TABLET
Route: ORAL
Labeler: Major Pharmaceuticals
Application: ANDA079088
Marketing category: ANDA
Marketing start: 2013-11-30
Marketing end: 0000-00-00
Substance: RISPERIDONE
Active strength: 1 mg/1
Pharmacologic classes: Atypical Antipsychotic [EPC]
NDC exclude flag: No
Listing certified through: 2023-12-31
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	0904-6358	0904-6358-61	D	Discontinued by firm		2026-09-14

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 · 6 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…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A079088-001	RISPERIDONE	RISPERIDONE	0.25MG	TABLET / ORAL	AB	2008-10-30
A079088-002	RISPERIDONE	RISPERIDONE	0.5MG	TABLET / ORAL	AB	2008-10-30
A079088-003	RISPERIDONE	RISPERIDONE	1MG	TABLET / ORAL	AB	2008-10-30
A079088-004	RISPERIDONE	RISPERIDONE	2MG	TABLET / ORAL	AB	2008-10-30
A079088-005	RISPERIDONE	RISPERIDONE	3MG	TABLET / ORAL	AB	2008-10-30
A079088-006	RISPERIDONE	RISPERIDONE	4MG	TABLET / ORAL	AB	2008-10-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A079088-001	AB
A079088-002	AB
A079088-003	AB
A079088-004	AB
A079088-005	AB
A079088-006	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 · 258 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
2026-09-14 22:38:34	2026-08	A079088-001	RISPERIDONE	0.25MG	TABLET / ORAL	AB	2008-10-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A079088-002	RISPERIDONE	0.5MG	TABLET / ORAL	AB	2008-10-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A079088-003	RISPERIDONE	1MG	TABLET / ORAL	AB	2008-10-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A079088-004	RISPERIDONE	2MG	TABLET / ORAL	AB	2008-10-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A079088-005	RISPERIDONE	3MG	TABLET / ORAL	AB	2008-10-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A079088-006	RISPERIDONE	4MG	TABLET / ORAL	AB	2008-10-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A079088-001	RISPERIDONE	0.25MG	TABLET / ORAL	AB	2008-10-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A079088-002	RISPERIDONE	0.5MG	TABLET / ORAL	AB	2008-10-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A079088-003	RISPERIDONE	1MG	TABLET / ORAL	AB	2008-10-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A079088-004	RISPERIDONE	2MG	TABLET / ORAL	AB	2008-10-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A079088-005	RISPERIDONE	3MG	TABLET / ORAL	AB	2008-10-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A079088-006	RISPERIDONE	4MG	TABLET / ORAL	AB	2008-10-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A079088-001	RISPERIDONE	0.25MG	TABLET / ORAL	AB	2008-10-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079088-002	RISPERIDONE	0.5MG	TABLET / ORAL	AB	2008-10-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079088-003	RISPERIDONE	1MG	TABLET / ORAL	AB	2008-10-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079088-004	RISPERIDONE	2MG	TABLET / ORAL	AB	2008-10-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079088-005	RISPERIDONE	3MG	TABLET / ORAL	AB	2008-10-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079088-006	RISPERIDONE	4MG	TABLET / ORAL	AB	2008-10-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079088-001	RISPERIDONE	0.25MG	TABLET / ORAL	AB	2008-10-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079088-002	RISPERIDONE	0.5MG	TABLET / ORAL	AB	2008-10-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079088-003	RISPERIDONE	1MG	TABLET / ORAL	AB	2008-10-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079088-004	RISPERIDONE	2MG	TABLET / ORAL	AB	2008-10-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079088-005	RISPERIDONE	3MG	TABLET / ORAL	AB	2008-10-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079088-006	RISPERIDONE	4MG	TABLET / ORAL	AB	2008-10-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079088-001	RISPERIDONE	0.25MG	TABLET / ORAL	AB	2008-10-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079088-002	RISPERIDONE	0.5MG	TABLET / ORAL	AB	2008-10-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079088-003	RISPERIDONE	1MG	TABLET / ORAL	AB	2008-10-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079088-004	RISPERIDONE	2MG	TABLET / ORAL	AB	2008-10-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079088-005	RISPERIDONE	3MG	TABLET / ORAL	AB	2008-10-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079088-006	RISPERIDONE	4MG	TABLET / ORAL	AB	2008-10-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079088-001	RISPERIDONE	0.25MG	TABLET / ORAL	AB	2008-10-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079088-002	RISPERIDONE	0.5MG	TABLET / ORAL	AB	2008-10-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079088-003	RISPERIDONE	1MG	TABLET / ORAL	AB	2008-10-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079088-004	RISPERIDONE	2MG	TABLET / ORAL	AB	2008-10-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079088-005	RISPERIDONE	3MG	TABLET / ORAL	AB	2008-10-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079088-006	RISPERIDONE	4MG	TABLET / ORAL	AB	2008-10-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079088-001	RISPERIDONE	0.25MG	TABLET / ORAL	AB	2008-10-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079088-002	RISPERIDONE	0.5MG	TABLET / ORAL	AB	2008-10-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079088-003	RISPERIDONE	1MG	TABLET / ORAL	AB	2008-10-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079088-004	RISPERIDONE	2MG	TABLET / ORAL	AB	2008-10-30	`b8a1b40f171c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 258 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A079088-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A079088-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A079088-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A079088-004	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A079088-005	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A079088-006	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A079088-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A079088-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A079088-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A079088-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A079088-005	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A079088-006	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A079088-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079088-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079088-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079088-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079088-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079088-006	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079088-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079088-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079088-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079088-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079088-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079088-006	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079088-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079088-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079088-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079088-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079088-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079088-006	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079088-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079088-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079088-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079088-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079088-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079088-006	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079088-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079088-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079088-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079088-004	AB	1	`b8a1b40f171c…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0904-6358-61	EA - Each	0904-6358	cf9b2306-d5ae-49b2-9995-fadbeb3db24a	1	2014-01-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
RISPERIDONE	ACTIVE INGREDIENT	L6UH7ZF8HC	RISPERIDONE TABLET [CARDINAL HEALTH]	6
RISPERIDONE	ACTIVE MOIETY	L6UH7ZF8HC	RISPERIDONE TABLET [CARDINAL HEALTH]	6
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	RISPERIDONE TABLET [CARDINAL HEALTH]	6
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	RISPERIDONE TABLET [CARDINAL HEALTH]	6
HYPROMELLOSE 2208 (100 MPA.S)	INACTIVE INGREDIENT	B1QE5P712K	RISPERIDONE TABLET [CARDINAL HEALTH]	6
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	RISPERIDONE TABLET [CARDINAL HEALTH]	6
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	RISPERIDONE TABLET [CARDINAL HEALTH]	6
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	RISPERIDONE TABLET [CARDINAL HEALTH]	6
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	RISPERIDONE TABLET [CARDINAL HEALTH]	6
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	RISPERIDONE TABLET [CARDINAL HEALTH]	6
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	RISPERIDONE TABLET [CARDINAL HEALTH]	6
STARCH, POTATO	INACTIVE INGREDIENT	8I089SAH3T	RISPERIDONE TABLET [CARDINAL HEALTH]	6
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	RISPERIDONE TABLET [CARDINAL HEALTH]	6
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	RISPERIDONE TABLET [CARDINAL HEALTH]	6
RISPERIDONE	ACTIVE INGREDIENT	L6UH7ZF8HC	RISPERIDONE TABLET [MAJOR PHARMACEUTICALS]	1
RISPERIDONE	ACTIVE MOIETY	L6UH7ZF8HC	RISPERIDONE TABLET [MAJOR PHARMACEUTICALS]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	RISPERIDONE TABLET [MAJOR PHARMACEUTICALS]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	RISPERIDONE TABLET [MAJOR PHARMACEUTICALS]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	RISPERIDONE TABLET [MAJOR PHARMACEUTICALS]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	RISPERIDONE TABLET [MAJOR PHARMACEUTICALS]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	RISPERIDONE TABLET [MAJOR PHARMACEUTICALS]	1
HYPROMELLOSE 2208 (100 MPA.S)	INACTIVE INGREDIENT	B1QE5P712K	RISPERIDONE TABLET [MAJOR PHARMACEUTICALS]	1
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	RISPERIDONE TABLET [MAJOR PHARMACEUTICALS]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	RISPERIDONE TABLET [MAJOR PHARMACEUTICALS]	1
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	RISPERIDONE TABLET [MAJOR PHARMACEUTICALS]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	RISPERIDONE TABLET [MAJOR PHARMACEUTICALS]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	RISPERIDONE TABLET [MAJOR PHARMACEUTICALS]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	RISPERIDONE TABLET [MAJOR PHARMACEUTICALS]	1
STARCH, POTATO	INACTIVE INGREDIENT	8I089SAH3T	RISPERIDONE TABLET [MAJOR PHARMACEUTICALS]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	RISPERIDONE TABLET [MAJOR PHARMACEUTICALS]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	RISPERIDONE TABLET [MAJOR PHARMACEUTICALS]	1

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	PD-Rx Pharmaceuticals, Inc.	e72a2768-815f-47bf-b2f9-16a93dd10684	2026-04-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079088 application number: ANDA079088
Risperidone	RISPERIDONE	Torrent Pharmaceuticals Limited	a6347895-5f16-43b4-92a0-b9904ac81937	2026-03-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079088 application number: ANDA079088

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	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0904-6358-61	00904635861	100 TABLET in 1 BOX, UNIT-DOSE (0904-6358-61)	100 tablet	2013-11-30	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Risperidone	Cardinal Health 107, LLC	2024-09-17	HUMAN PRESCRIPTION DRUG LABEL	15
Risperidone	Major Pharmaceuticals	2024-06-26	HUMAN PRESCRIPTION DRUG LABEL	7