Risperidone

Product NDC: 63629-4505
11-digit product format: 636294505
Labeler code: 63629
Product ID: 63629-4505_be0fe24f-621c-4187-823f-bcb587c2ef73
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: risperidone
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA078707
Marketing category: ANDA
Marketing start: 2008-12-29
Marketing end: 0000-00-00
Substance: RISPERIDONE
Active strength: 3 mg/1
Pharmacologic classes: Atypical Antipsychotic [EPC]
NDC exclude flag: E
Listing certified through: 2017-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	63629-4505		D	Discontinued by firm	2026-08-03
excluded package	package	63629-4505	63629-4505-1	D	Discontinued by firm	2026-08-03
excluded package	package	63629-4505	63629-4505-2	D	Discontinued by firm	2026-08-03
excluded package	package	63629-4505	63629-4505-3	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 · 57 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63629-4505-2	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63629-4505-3	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63629-4505-1	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63629-4505-2	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63629-4505-3	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63629-4505-1	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63629-4505-2	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63629-4505-3	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63629-4505-1	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63629-4505-2	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63629-4505-3	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63629-4505-1	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63629-4505-2	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63629-4505-3	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63629-4505-1	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63629-4505-2	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63629-4505-3	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63629-4505-1	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63629-4505-2	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63629-4505-3	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63629-4505-1	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	63629-4505-2	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	63629-4505-3	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	63629-4505-1	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	63629-4505-2	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	63629-4505-3	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	63629-4505-1	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	63629-4505-2	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	63629-4505-3	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	63629-4505-1	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	63629-4505-2	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	63629-4505-3	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	63629-4505-1	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	63629-4505-2	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	63629-4505-3	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	63629-4505-1	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	63629-4505-2	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	63629-4505-1	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	63629-4505-2	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	63629-4505-1	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		I	Inactivated by FDA	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	63629-4505-2	I	Inactivated by FDA	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	63629-4505-1	I	Inactivated by FDA	`110d247fa046…`	`a55b01930146…`

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
A078707-001	RISPERIDONE	RISPERIDONE	0.25MG	TABLET / ORAL	AB	2008-12-29
A078707-002	RISPERIDONE	RISPERIDONE	0.5MG	TABLET / ORAL	AB	2008-12-29
A078707-003	RISPERIDONE	RISPERIDONE	1MG	TABLET / ORAL	AB	2008-12-29
A078707-004	RISPERIDONE	RISPERIDONE	2MG	TABLET / ORAL	AB	2008-12-29
A078707-005	RISPERIDONE	RISPERIDONE	3MG	TABLET / ORAL	AB	2008-12-29
A078707-006	RISPERIDONE	RISPERIDONE	4MG	TABLET / ORAL	AB	2008-12-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078707-001	AB
A078707-002	AB
A078707-003	AB
A078707-004	AB
A078707-005	AB
A078707-006	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	A078707-001	RISPERIDONE	0.25MG	TABLET / ORAL	AB	2008-12-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078707-002	RISPERIDONE	0.5MG	TABLET / ORAL	AB	2008-12-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078707-003	RISPERIDONE	1MG	TABLET / ORAL	AB	2008-12-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078707-004	RISPERIDONE	2MG	TABLET / ORAL	AB	2008-12-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078707-005	RISPERIDONE	3MG	TABLET / ORAL	AB	2008-12-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078707-006	RISPERIDONE	4MG	TABLET / ORAL	AB	2008-12-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078707-001	RISPERIDONE	0.25MG	TABLET / ORAL	AB	2008-12-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078707-002	RISPERIDONE	0.5MG	TABLET / ORAL	AB	2008-12-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078707-003	RISPERIDONE	1MG	TABLET / ORAL	AB	2008-12-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078707-004	RISPERIDONE	2MG	TABLET / ORAL	AB	2008-12-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078707-005	RISPERIDONE	3MG	TABLET / ORAL	AB	2008-12-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078707-006	RISPERIDONE	4MG	TABLET / ORAL	AB	2008-12-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078707-001	RISPERIDONE	0.25MG	TABLET / ORAL	AB	2008-12-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078707-002	RISPERIDONE	0.5MG	TABLET / ORAL	AB	2008-12-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078707-003	RISPERIDONE	1MG	TABLET / ORAL	AB	2008-12-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078707-004	RISPERIDONE	2MG	TABLET / ORAL	AB	2008-12-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078707-005	RISPERIDONE	3MG	TABLET / ORAL	AB	2008-12-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078707-006	RISPERIDONE	4MG	TABLET / ORAL	AB	2008-12-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078707-001	RISPERIDONE	0.25MG	TABLET / ORAL	AB	2008-12-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078707-002	RISPERIDONE	0.5MG	TABLET / ORAL	AB	2008-12-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078707-003	RISPERIDONE	1MG	TABLET / ORAL	AB	2008-12-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078707-004	RISPERIDONE	2MG	TABLET / ORAL	AB	2008-12-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078707-005	RISPERIDONE	3MG	TABLET / ORAL	AB	2008-12-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078707-006	RISPERIDONE	4MG	TABLET / ORAL	AB	2008-12-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078707-001	RISPERIDONE	0.25MG	TABLET / ORAL	AB	2008-12-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078707-002	RISPERIDONE	0.5MG	TABLET / ORAL	AB	2008-12-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078707-003	RISPERIDONE	1MG	TABLET / ORAL	AB	2008-12-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078707-004	RISPERIDONE	2MG	TABLET / ORAL	AB	2008-12-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078707-005	RISPERIDONE	3MG	TABLET / ORAL	AB	2008-12-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078707-006	RISPERIDONE	4MG	TABLET / ORAL	AB	2008-12-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078707-001	RISPERIDONE	0.25MG	TABLET / ORAL	AB	2008-12-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078707-002	RISPERIDONE	0.5MG	TABLET / ORAL	AB	2008-12-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078707-003	RISPERIDONE	1MG	TABLET / ORAL	AB	2008-12-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078707-004	RISPERIDONE	2MG	TABLET / ORAL	AB	2008-12-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078707-005	RISPERIDONE	3MG	TABLET / ORAL	AB	2008-12-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078707-006	RISPERIDONE	4MG	TABLET / ORAL	AB	2008-12-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078707-001	RISPERIDONE	0.25MG	TABLET / ORAL	AB	2008-12-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078707-002	RISPERIDONE	0.5MG	TABLET / ORAL	AB	2008-12-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078707-003	RISPERIDONE	1MG	TABLET / ORAL	AB	2008-12-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078707-004	RISPERIDONE	2MG	TABLET / ORAL	AB	2008-12-29	`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	A078707-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078707-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078707-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078707-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078707-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078707-006	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078707-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078707-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078707-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078707-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078707-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078707-006	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078707-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078707-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078707-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078707-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078707-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078707-006	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078707-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078707-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078707-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078707-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078707-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078707-006	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078707-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078707-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078707-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078707-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078707-005	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078707-006	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078707-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078707-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078707-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078707-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078707-005	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078707-006	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078707-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078707-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078707-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078707-004	AB	1	`2680178bc6a6…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
63629-4505-1	2021-06-01	These highlights do not include all the information needed to use Risperidone tablets USP safely and effectively. See full prescribing information for Risperidone tablets USP. Risperidone Tablets USP, for oral use Initial U.S. Approval: 1993
63629-4505-2	2021-06-01	These highlights do not include all the information needed to use Risperidone tablets USP safely and effectively. See full prescribing information for Risperidone tablets USP. Risperidone Tablets USP, for oral use Initial U.S. Approval: 1993
63629-4505-1	2019-11-27	These highlights do not include all the information needed to use Risperidone tablets USP safely and effectively. See full prescribing information for Risperidone tablets USP. Risperidone Tablets USP, for oral use Initial U.S. Approval: 1993
63629-4505-2	2019-11-27	These highlights do not include all the information needed to use Risperidone tablets USP safely and effectively. See full prescribing information for Risperidone tablets USP. 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 [BRYANT RANCH PREPACK]	1000
RISPERIDONE	ACTIVE MOIETY	L6UH7ZF8HC	RISPERIDONE TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	RISPERIDONE TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	RISPERIDONE TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	RISPERIDONE TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	RISPERIDONE TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	RISPERIDONE TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	RISPERIDONE TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	RISPERIDONE TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	RISPERIDONE TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	RISPERIDONE TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	RISPERIDONE TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	RISPERIDONE TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	RISPERIDONE TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Risperidone	RISPERIDONE	Westminster Pharmaceuticals, LLC	07d43bf6-a695-453a-a5c7-9581effe585c	2025-12-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078707 application number: ANDA078707
Risperidone	RISPERIDONE	AvKARE	3d4c51e2-b09b-9fd0-e063-6294a90ae699	2025-08-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078707 application number: ANDA078707
Risperidone	RISPERIDONE	AvKARE	2f9ea0cc-b86b-a11f-e063-6294a90a9620	2025-03-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078707 application number: ANDA078707