Risperidone

Product NDC: 0781-5313
11-digit product format: 007815313
Labeler code: 0781
Product ID: 0781-5313_483b5267-344e-4ba9-b6d8-a8bff8f7108e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Risperidone
Dosage form: TABLET, ORALLY DISINTEGRATING
Route: ORAL
Labeler: Sandoz Inc
Application: ANDA078116
Marketing category: ANDA
Marketing start: 2009-12-22
Marketing end: 0000-00-00
Substance: RISPERIDONE
Active strength: 3 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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	0781-5313		D	Discontinued by firm		2026-10-16
excluded package	package	0781-5313	0781-5313-08	D	Discontinued by firm		2026-10-16

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	0781-5313-08	`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	0781-5313-08	`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	0781-5313-08	`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	0781-5313-08	`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	0781-5313-08	`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	0781-5313-08	`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	0781-5313-08	`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	0781-5313-08	`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	0781-5313-08	`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	0781-5313-08	`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	0781-5313-08	`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	0781-5313-08	`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	TE codes	Approval date
A078116-001	RISPERIDONE	RISPERIDONE	0.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-12-22
A078116-002	RISPERIDONE	RISPERIDONE	1MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-12-22
A078116-003	RISPERIDONE	RISPERIDONE	2MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-12-22
A078116-004	RISPERIDONE	RISPERIDONE	3MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-12-22
A078116-005	RISPERIDONE	RISPERIDONE	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-12-22

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-product	TE code
A078116-001	AB
A078116-002	AB
A078116-003	AB
A078116-004	AB
A078116-005	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 6 · 220 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
2026-10-15 13:18:30	2026-09	A078116-001	RISPERIDONE	0.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-12-22	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A078116-002	RISPERIDONE	1MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-12-22	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A078116-003	RISPERIDONE	2MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-12-22	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A078116-004	RISPERIDONE	3MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-12-22	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A078116-005	RISPERIDONE	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-12-22	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A078116-001	RISPERIDONE	0.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-12-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078116-002	RISPERIDONE	1MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-12-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078116-003	RISPERIDONE	2MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-12-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078116-004	RISPERIDONE	3MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-12-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078116-005	RISPERIDONE	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-12-22	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078116-001	RISPERIDONE	0.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-12-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078116-002	RISPERIDONE	1MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-12-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078116-003	RISPERIDONE	2MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-12-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078116-004	RISPERIDONE	3MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-12-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078116-005	RISPERIDONE	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-12-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078116-001	RISPERIDONE	0.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-12-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078116-002	RISPERIDONE	1MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-12-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078116-003	RISPERIDONE	2MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-12-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078116-004	RISPERIDONE	3MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-12-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078116-005	RISPERIDONE	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-12-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078116-001	RISPERIDONE	0.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-12-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078116-002	RISPERIDONE	1MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-12-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078116-003	RISPERIDONE	2MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-12-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078116-004	RISPERIDONE	3MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-12-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078116-005	RISPERIDONE	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-12-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078116-001	RISPERIDONE	0.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-12-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078116-002	RISPERIDONE	1MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-12-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078116-003	RISPERIDONE	2MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-12-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078116-004	RISPERIDONE	3MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-12-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078116-005	RISPERIDONE	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-12-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078116-001	RISPERIDONE	0.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-12-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078116-002	RISPERIDONE	1MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-12-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078116-003	RISPERIDONE	2MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-12-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078116-004	RISPERIDONE	3MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-12-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078116-005	RISPERIDONE	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-12-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078116-001	RISPERIDONE	0.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-12-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078116-002	RISPERIDONE	1MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-12-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078116-003	RISPERIDONE	2MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-12-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078116-004	RISPERIDONE	3MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-12-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078116-005	RISPERIDONE	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-12-22	`b8a1b40f171c…`

Observed Orange Book normalized TE history#

Normalized TE history page 4 of 6 · 220 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2021-03-12 10:30 UTC	2021-03	A078116-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A078116-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A078116-003	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A078116-004	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A078116-005	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078116-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A078116-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A078116-003	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A078116-004	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A078116-005	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078116-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A078116-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A078116-003	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A078116-004	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A078116-005	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078116-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A078116-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A078116-003	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A078116-004	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A078116-005	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078116-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A078116-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A078116-003	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A078116-004	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A078116-005	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078116-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A078116-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A078116-003	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A078116-004	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A078116-005	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078116-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078116-002	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078116-003	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078116-004	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078116-005	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078116-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A078116-002	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A078116-003	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A078116-004	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A078116-005	AB	1	`1c564ffb4f44…`

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
0781-5313-06	EA - Each	0781-5313	2af3023a-956b-42aa-93ce-3f8aa246d5ed	1	2016-12-07
0781-5313-08	EA - Each	0781-5313	9dc37606-a7cc-4b25-b820-86cbd866cd20	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
RISPERIDONE	ACTIVE INGREDIENT	L6UH7ZF8HC	RISPERIDONE TABLET, ORALLY DISINTEGRATING [SANDOZ INC]	8
RISPERIDONE	ACTIVE MOIETY	L6UH7ZF8HC	RISPERIDONE TABLET, ORALLY DISINTEGRATING [SANDOZ INC]	8
ACESULFAME	INACTIVE INGREDIENT	MA3UYZ6K1H	RISPERIDONE TABLET, ORALLY DISINTEGRATING [SANDOZ INC]	8
AMMONIUM GLYCYRRHIZATE	INACTIVE INGREDIENT	3VRD35U26C	RISPERIDONE TABLET, ORALLY DISINTEGRATING [SANDOZ INC]	8
ASPARTAME	INACTIVE INGREDIENT	Z0H242BBR1	RISPERIDONE TABLET, ORALLY DISINTEGRATING [SANDOZ INC]	8
CALCIUM STEARATE	INACTIVE INGREDIENT	776XM7047L	RISPERIDONE TABLET, ORALLY DISINTEGRATING [SANDOZ INC]	8
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	RISPERIDONE TABLET, ORALLY DISINTEGRATING [SANDOZ INC]	8
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	RISPERIDONE TABLET, ORALLY DISINTEGRATING [SANDOZ INC]	8
MALTODEXTRIN	INACTIVE INGREDIENT	7CVR7L4A2D	RISPERIDONE TABLET, ORALLY DISINTEGRATING [SANDOZ INC]	8
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	RISPERIDONE TABLET, ORALLY DISINTEGRATING [SANDOZ INC]	8
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)	INACTIVE INGREDIENT	461P5CJN6T	RISPERIDONE TABLET, ORALLY DISINTEGRATING [SANDOZ INC]	8
SUCROSE	INACTIVE INGREDIENT	C151H8M554	RISPERIDONE TABLET, ORALLY DISINTEGRATING [SANDOZ INC]	8

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
0781-5313-08	00781531308	28 BLISTER PACK in 1 CARTON (0781-5313-08) > 1 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (0781-5313-06)	28 blister pack	2009-12-22	0000-00-00	No	No	Current