risperidone

Product NDC: 64725-0114
11-digit product format: 647250114
Labeler code: 64725
Product ID: 64725-0114_271f3da1-d81a-4938-94bd-84486e946655
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: risperidone
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: TYA Pharmaceuticals
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: 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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	64725-0114		I	Inactivated by FDA		2026-08-03
excluded package	package	64725-0114	64725-0114-1	I	Inactivated by FDA		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 · 44 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	64725-0114-1	`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	64725-0114-1	`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	64725-0114-1	`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	64725-0114-1	`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	64725-0114-1	`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	64725-0114-1	`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	64725-0114-1	`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	64725-0114-1	`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	64725-0114-1	`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	64725-0114-1	`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	64725-0114-1	`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	64725-0114-1	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	64725-0114-1	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	64725-0114-1	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	64725-0114-1	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	64725-0114-1	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	64725-0114-1	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	64725-0114-1	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	64725-0114-1	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	64725-0114-1	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	64725-0114-1	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	64725-0114-1	`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
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…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6ab2126a-0ca2-c16c-ab6d-b3a031ba7ac6	Product name	5	20250303
0efa9fd6-2fb6-4cd3-8b0f-2a2bf9c4a09e	Product name	1	20250128
e457a910-2c3a-4bfd-90b9-0310982c50dd	Product name	1	20241218
42b1a2d5-888a-4386-ab9f-0979e0d7b4aa	Product name	1	20231010
66685e90-862d-4873-a0c5-2be73b803c36	Product name	1	20230921
92d220a1-2a4c-4393-9080-7335ca8223cc	Product name	1	20230823

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
64725-0114-1	2019-11-27	C162847	48780-1	9855e2a2-33ae-60a7-e053-dbdaa90a05bd	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 Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
64725-0114-1	risperidone	60 in 1 BOTTLE	TABLET, FILM COATED	60		4

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
RISPERIDONE	ACTIVE INGREDIENT	L6UH7ZF8HC	RISPERIDONE TABLET, FILM COATED [TYA PHARMACEUTICALS]	4
RISPERIDONE	ACTIVE MOIETY	L6UH7ZF8HC	RISPERIDONE TABLET, FILM COATED [TYA PHARMACEUTICALS]	4
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	RISPERIDONE TABLET, FILM COATED [TYA PHARMACEUTICALS]	4
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	RISPERIDONE TABLET, FILM COATED [TYA PHARMACEUTICALS]	4
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	RISPERIDONE TABLET, FILM COATED [TYA PHARMACEUTICALS]	4
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	RISPERIDONE TABLET, FILM COATED [TYA PHARMACEUTICALS]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	RISPERIDONE TABLET, FILM COATED [TYA PHARMACEUTICALS]	4
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	RISPERIDONE TABLET, FILM COATED [TYA PHARMACEUTICALS]	4
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	RISPERIDONE TABLET, FILM COATED [TYA PHARMACEUTICALS]	4
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	RISPERIDONE TABLET, FILM COATED [TYA PHARMACEUTICALS]	4
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	RISPERIDONE TABLET, FILM COATED [TYA PHARMACEUTICALS]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
64725-0114	RISPERIDONE TABLET, FILM COATED [TYA PHARMACEUTICALS]	4	Legacy NDC, 1 package rows	20140902_10bf6ea7-fc6d-4cf1-8074-f80f6af9cf5c.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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
312829	risperiDONE 0.5 MG Oral Tablet	PSN	10bf6ea7-fc6d-4cf1-8074-f80f6af9cf5c	4
312830	risperiDONE 1 MG Oral Tablet	PSN	10bf6ea7-fc6d-4cf1-8074-f80f6af9cf5c	4
312829	risperidone 0.5 MG Oral Tablet	SCD	10bf6ea7-fc6d-4cf1-8074-f80f6af9cf5c	4
312830	risperidone 1 MG Oral Tablet	SCD	10bf6ea7-fc6d-4cf1-8074-f80f6af9cf5c	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
64725-0114-1	64725011401	60 in 1 BOTTLE	Historical