Risperidone

Product NDC: 70518-2969
11-digit product format: 705182969
Labeler code: 70518
Product ID: 70518-2969_d7abf12b-b5f2-1426-e053-2995a90af240
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Risperidone
Dosage form: TABLET
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA077493
Marketing category: ANDA
Marketing start: 2020-12-15
Marketing end: 0000-00-00
Substance: RISPERIDONE
Active strength: 4 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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	70518-2969		D	Discontinued by firm	2026-08-03
excluded package	package	70518-2969	70518-2969-0	D	Discontinued by firm	2026-08-03
excluded package	package	70518-2969	70518-2969-1	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 · 16 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	70518-2969-0	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	70518-2969-1	`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	70518-2969-0	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	70518-2969-1	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	70518-2969-0	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	70518-2969-0	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	70518-2969-0	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	70518-2969-0	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	70518-2969-0	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	70518-2969-0	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	70518-2969-0	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	70518-2969-0	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	70518-2969-0	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	70518-2969-0	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
A077493-001	RISPERIDONE	RISPERIDONE	0.25MG	TABLET / ORAL	AB	2011-11-29
A077493-002	RISPERIDONE	RISPERIDONE	0.5MG	TABLET / ORAL	AB	2011-11-29
A077493-003	RISPERIDONE	RISPERIDONE	1MG	TABLET / ORAL	AB	2011-11-29
A077493-004	RISPERIDONE	RISPERIDONE	2MG	TABLET / ORAL	AB	2011-11-29
A077493-005	RISPERIDONE	RISPERIDONE	3MG	TABLET / ORAL	AB	2011-11-29
A077493-006	RISPERIDONE	RISPERIDONE	4MG	TABLET / ORAL	AB	2011-11-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077493-001	AB
A077493-002	AB
A077493-003	AB
A077493-004	AB
A077493-005	AB
A077493-006	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	A077493-001	RISPERIDONE	0.25MG	TABLET / ORAL	AB	2011-11-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077493-002	RISPERIDONE	0.5MG	TABLET / ORAL	AB	2011-11-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077493-003	RISPERIDONE	1MG	TABLET / ORAL	AB	2011-11-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077493-004	RISPERIDONE	2MG	TABLET / ORAL	AB	2011-11-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077493-005	RISPERIDONE	3MG	TABLET / ORAL	AB	2011-11-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077493-006	RISPERIDONE	4MG	TABLET / ORAL	AB	2011-11-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077493-001	RISPERIDONE	0.25MG	TABLET / ORAL	AB	2011-11-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077493-002	RISPERIDONE	0.5MG	TABLET / ORAL	AB	2011-11-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077493-003	RISPERIDONE	1MG	TABLET / ORAL	AB	2011-11-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077493-004	RISPERIDONE	2MG	TABLET / ORAL	AB	2011-11-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077493-005	RISPERIDONE	3MG	TABLET / ORAL	AB	2011-11-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077493-006	RISPERIDONE	4MG	TABLET / ORAL	AB	2011-11-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077493-001	RISPERIDONE	0.25MG	TABLET / ORAL	AB	2011-11-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077493-002	RISPERIDONE	0.5MG	TABLET / ORAL	AB	2011-11-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077493-003	RISPERIDONE	1MG	TABLET / ORAL	AB	2011-11-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077493-004	RISPERIDONE	2MG	TABLET / ORAL	AB	2011-11-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077493-005	RISPERIDONE	3MG	TABLET / ORAL	AB	2011-11-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077493-006	RISPERIDONE	4MG	TABLET / ORAL	AB	2011-11-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077493-001	RISPERIDONE	0.25MG	TABLET / ORAL	AB	2011-11-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077493-002	RISPERIDONE	0.5MG	TABLET / ORAL	AB	2011-11-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077493-003	RISPERIDONE	1MG	TABLET / ORAL	AB	2011-11-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077493-004	RISPERIDONE	2MG	TABLET / ORAL	AB	2011-11-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077493-005	RISPERIDONE	3MG	TABLET / ORAL	AB	2011-11-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077493-006	RISPERIDONE	4MG	TABLET / ORAL	AB	2011-11-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077493-001	RISPERIDONE	0.25MG	TABLET / ORAL	AB	2011-11-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077493-002	RISPERIDONE	0.5MG	TABLET / ORAL	AB	2011-11-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077493-003	RISPERIDONE	1MG	TABLET / ORAL	AB	2011-11-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077493-004	RISPERIDONE	2MG	TABLET / ORAL	AB	2011-11-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077493-005	RISPERIDONE	3MG	TABLET / ORAL	AB	2011-11-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077493-006	RISPERIDONE	4MG	TABLET / ORAL	AB	2011-11-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077493-001	RISPERIDONE	0.25MG	TABLET / ORAL	AB	2011-11-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077493-002	RISPERIDONE	0.5MG	TABLET / ORAL	AB	2011-11-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077493-003	RISPERIDONE	1MG	TABLET / ORAL	AB	2011-11-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077493-004	RISPERIDONE	2MG	TABLET / ORAL	AB	2011-11-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077493-005	RISPERIDONE	3MG	TABLET / ORAL	AB	2011-11-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077493-006	RISPERIDONE	4MG	TABLET / ORAL	AB	2011-11-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077493-001	RISPERIDONE	0.25MG	TABLET / ORAL	AB	2011-11-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077493-002	RISPERIDONE	0.5MG	TABLET / ORAL	AB	2011-11-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077493-003	RISPERIDONE	1MG	TABLET / ORAL	AB	2011-11-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077493-004	RISPERIDONE	2MG	TABLET / ORAL	AB	2011-11-29	`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	A077493-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077493-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077493-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077493-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077493-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077493-006	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077493-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077493-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077493-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077493-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077493-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077493-006	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077493-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077493-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077493-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077493-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077493-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077493-006	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077493-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077493-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077493-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077493-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077493-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077493-006	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077493-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077493-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077493-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077493-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077493-005	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077493-006	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077493-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077493-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077493-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077493-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077493-005	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077493-006	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077493-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077493-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077493-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077493-004	AB	1	`2680178bc6a6…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
70518-2969-0	2022-02-10	C162847	48780-1	d6a99b3a-0116-a426-e053-dadaa90af4c2	These highlights do not include all the information needed to use RISPERIDONE TABLETS safely and effectively. See full prescribing information for RISPERIDONE TABLETS. RISPERIDONE tablets, for oral use Initial U.S. Approval: 1993
70518-2969-0	2022-01-28	C162847	48780-1	d6a99b3a-0116-a426-e053-dadaa90af4c2	These highlights do not include all the information needed to use RISPERIDONE TABLETS safely and effectively. See full prescribing information for RISPERIDONE TABLETS. RISPERIDONE tablets, for oral use Initial U.S. Approval: 1993

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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Risperidone	RISPERIDONE	Coupler LLC	55f3ebec-a742-48fc-e063-6394a90a1452	2026-07-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077493 application number: ANDA077493
Risperidone	RISPERIDONE	REMEDYREPACK INC.	c84807bd-35d7-4138-8989-42617d69293a	2026-06-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077493 application number: ANDA077493
Risperidone	RISPERIDONE	Solco Healthcare US, LLC	43aa2a4f-1123-4f86-800b-9218882f7bcd	2026-03-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077493 application number: ANDA077493
Risperidone	RISPERIDONE	REMEDYREPACK INC.	3261e8cf-cc6e-4011-9246-aee623ad8971	2025-08-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077493 application number: ANDA077493
Risperidone	RISPERIDONE	REMEDYREPACK INC.	339ec0af-c0f0-4115-8cdb-8f052e633f47	2025-08-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077493 application number: ANDA077493
Risperidone	RISPERIDONE	NuCare Pharmaceuticals, Inc.	390904c2-fcfa-466e-e063-6394a90a03af	2025-07-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077493 application number: ANDA077493
Risperidone	RISPERIDONE	Bryant Ranch Prepack	684dcda4-d270-400c-9798-7d920a038bbb	2025-06-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077493 application number: ANDA077493
Risperidone	RISPERIDONE	NCS HealthCare of KY, LLC dba Vangard Labs	7bbc37f1-6d6a-4021-8976-1f103ce1cfbd	2023-02-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077493 application number: ANDA077493
Risperidone	RISPERIDONE	Aphena Pharma Solutions - Tennessee, LLC	58e422ec-da66-41b0-83c1-aefd940beda0	2019-04-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077493 application number: ANDA077493

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
70518-2969-0	70518296900	28 TABLET in 1 BLISTER PACK (70518-2969-0)	28 tablet	2020-12-15	0000-00-00	No	No	Current