RISPERIDONE

Product NDC: 64725-0319
11-digit product format: 647250319
Labeler code: 64725
Product ID: 64725-0319_ee72430a-f6cd-4cbc-a312-102c266bf965
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: RISPERIDONE
Dosage form: TABLET
Route: ORAL
Labeler: TYA Pharmaceuticals
Application: ANDA201003
Marketing category: ANDA
Marketing start: 2012-04-25
Marketing end: 0000-00-00
Substance: RISPERIDONE
Active strength: 2 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	64725-0319		I	Inactivated by FDA		2026-08-03
excluded package	package	64725-0319	64725-0319-1	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	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	64725-0319-1	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	64725-0319-1	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	64725-0319-1	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	64725-0319-1	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	64725-0319-1	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	64725-0319-1	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	64725-0319-1	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	64725-0319-1	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	64725-0319-1	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	64725-0319-1	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	64725-0319-1	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	64725-0319-1	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	64725-0319-1	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	64725-0319-1	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	64725-0319-1	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	64725-0319-1	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	64725-0319-1	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	64725-0319-1	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	64725-0319-1	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
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	64725-0319-1	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	64725-0319-1	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	64725-0319-1	E	Excluded after deficient or non-compliant submission was not corrected	`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
A201003-001	RISPERIDONE	RISPERIDONE	0.25MG	TABLET / ORAL	AB	2011-08-24
A201003-002	RISPERIDONE	RISPERIDONE	0.5MG	TABLET / ORAL	AB	2011-08-24
A201003-003	RISPERIDONE	RISPERIDONE	1MG	TABLET / ORAL	AB	2011-08-24
A201003-004	RISPERIDONE	RISPERIDONE	2MG	TABLET / ORAL	AB	2011-08-24
A201003-005	RISPERIDONE	RISPERIDONE	3MG	TABLET / ORAL	AB	2011-08-24
A201003-006	RISPERIDONE	RISPERIDONE	4MG	TABLET / ORAL	AB	2011-08-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A201003-001	AB
A201003-002	AB
A201003-003	AB
A201003-004	AB
A201003-005	AB
A201003-006	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	A201003-001	RISPERIDONE	0.25MG	TABLET / ORAL	AB	2011-08-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201003-002	RISPERIDONE	0.5MG	TABLET / ORAL	AB	2011-08-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201003-003	RISPERIDONE	1MG	TABLET / ORAL	AB	2011-08-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201003-004	RISPERIDONE	2MG	TABLET / ORAL	AB	2011-08-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201003-005	RISPERIDONE	3MG	TABLET / ORAL	AB	2011-08-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201003-006	RISPERIDONE	4MG	TABLET / ORAL	AB	2011-08-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201003-001	RISPERIDONE	0.25MG	TABLET / ORAL	AB	2011-08-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201003-002	RISPERIDONE	0.5MG	TABLET / ORAL	AB	2011-08-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201003-003	RISPERIDONE	1MG	TABLET / ORAL	AB	2011-08-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201003-004	RISPERIDONE	2MG	TABLET / ORAL	AB	2011-08-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201003-005	RISPERIDONE	3MG	TABLET / ORAL	AB	2011-08-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201003-006	RISPERIDONE	4MG	TABLET / ORAL	AB	2011-08-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201003-001	RISPERIDONE	0.25MG	TABLET / ORAL	AB	2011-08-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201003-002	RISPERIDONE	0.5MG	TABLET / ORAL	AB	2011-08-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201003-003	RISPERIDONE	1MG	TABLET / ORAL	AB	2011-08-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201003-004	RISPERIDONE	2MG	TABLET / ORAL	AB	2011-08-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201003-005	RISPERIDONE	3MG	TABLET / ORAL	AB	2011-08-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201003-006	RISPERIDONE	4MG	TABLET / ORAL	AB	2011-08-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201003-001	RISPERIDONE	0.25MG	TABLET / ORAL	AB	2011-08-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201003-002	RISPERIDONE	0.5MG	TABLET / ORAL	AB	2011-08-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201003-003	RISPERIDONE	1MG	TABLET / ORAL	AB	2011-08-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201003-004	RISPERIDONE	2MG	TABLET / ORAL	AB	2011-08-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201003-005	RISPERIDONE	3MG	TABLET / ORAL	AB	2011-08-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201003-006	RISPERIDONE	4MG	TABLET / ORAL	AB	2011-08-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201003-001	RISPERIDONE	0.25MG	TABLET / ORAL	AB	2011-08-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201003-002	RISPERIDONE	0.5MG	TABLET / ORAL	AB	2011-08-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201003-003	RISPERIDONE	1MG	TABLET / ORAL	AB	2011-08-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201003-004	RISPERIDONE	2MG	TABLET / ORAL	AB	2011-08-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201003-005	RISPERIDONE	3MG	TABLET / ORAL	AB	2011-08-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201003-006	RISPERIDONE	4MG	TABLET / ORAL	AB	2011-08-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201003-001	RISPERIDONE	0.25MG	TABLET / ORAL	AB	2011-08-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201003-002	RISPERIDONE	0.5MG	TABLET / ORAL	AB	2011-08-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201003-003	RISPERIDONE	1MG	TABLET / ORAL	AB	2011-08-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201003-004	RISPERIDONE	2MG	TABLET / ORAL	AB	2011-08-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201003-005	RISPERIDONE	3MG	TABLET / ORAL	AB	2011-08-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201003-006	RISPERIDONE	4MG	TABLET / ORAL	AB	2011-08-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201003-001	RISPERIDONE	0.25MG	TABLET / ORAL	AB	2011-08-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201003-002	RISPERIDONE	0.5MG	TABLET / ORAL	AB	2011-08-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201003-003	RISPERIDONE	1MG	TABLET / ORAL	AB	2011-08-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201003-004	RISPERIDONE	2MG	TABLET / ORAL	AB	2011-08-24	`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	A201003-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201003-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201003-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201003-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201003-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201003-006	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201003-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201003-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201003-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201003-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201003-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201003-006	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201003-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201003-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201003-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201003-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201003-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201003-006	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201003-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201003-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201003-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201003-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201003-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201003-006	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201003-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201003-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201003-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201003-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201003-005	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201003-006	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201003-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201003-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201003-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201003-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201003-005	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201003-006	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201003-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201003-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201003-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201003-004	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
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
64725-0319-1	2020-01-31	C162847	48780-1	9d75b9cf-e19b-f424-e053-dadaa90a57ce	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 USP Initial U.S. Approval: 1993

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
64725-0319-1	RISPERIDONE	30 in 1 CONTAINER	TABLET	30		4

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
RISPERIDONE	ACTIVE INGREDIENT	L6UH7ZF8HC	RISPERIDONE TABLET [TYA PHARMACEUTICALS]	4
RISPERIDONE	ACTIVE MOIETY	L6UH7ZF8HC	RISPERIDONE TABLET [TYA PHARMACEUTICALS]	4
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	RISPERIDONE TABLET [TYA PHARMACEUTICALS]	4
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	RISPERIDONE TABLET [TYA PHARMACEUTICALS]	4
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	RISPERIDONE TABLET [TYA PHARMACEUTICALS]	4
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	RISPERIDONE TABLET [TYA PHARMACEUTICALS]	4
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	RISPERIDONE TABLET [TYA PHARMACEUTICALS]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	RISPERIDONE TABLET [TYA PHARMACEUTICALS]	4
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	RISPERIDONE TABLET [TYA PHARMACEUTICALS]	4
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	RISPERIDONE TABLET [TYA PHARMACEUTICALS]	4
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	RISPERIDONE TABLET [TYA PHARMACEUTICALS]	4
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	RISPERIDONE TABLET [TYA PHARMACEUTICALS]	4
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	RISPERIDONE TABLET [TYA PHARMACEUTICALS]	4
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	RISPERIDONE TABLET [TYA PHARMACEUTICALS]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
64725-0319	RISPERIDONE TABLET [TYA PHARMACEUTICALS]	4	Legacy NDC, 1 package rows	20141020_1097d343-413d-49fc-8bc9-34a1fdc0b643.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 2 · 25 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
RISPERIDONE	RISPERIDONE	Coupler LLC	5643c32b-310e-4888-e063-6394a90ab62f	2026-07-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201003 application number: ANDA201003
RISPERIDONE	RISPERIDONE	REMEDYREPACK INC.	ee495f20-c668-4d8f-9684-1029a4f232db	2026-07-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201003 application number: ANDA201003
RISPERIDONE	RISPERIDONE	REMEDYREPACK INC.	03d3b52d-3a7d-4595-84c9-332da6ca9171	2026-06-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201003 application number: ANDA201003
RISPERIDONE	RISPERIDONE	Coupler LLC	52bb35ac-1f7d-bfbe-e063-6294a90aa2b9	2026-06-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201003 application number: ANDA201003
RISPERIDONE	RISPERIDONE	A-S Medication Solutions	a6767972-2d3f-482b-80bd-ac93e28fdd05	2026-04-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201003 application number: ANDA201003
RISPERIDONE	RISPERIDONE	PD-Rx Pharmaceuticals, Inc.	bdb08381-dbfc-442e-8d3c-22d3a0f2f6c5	2026-03-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201003 application number: ANDA201003
RISPERIDONE	RISPERIDONE	REMEDYREPACK INC.	2776a647-678d-465c-9db3-4a9459ce779e	2026-01-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201003 application number: ANDA201003
RISPERIDONE	RISPERIDONE	REMEDYREPACK INC.	5d9519af-5a5e-47ce-8a0f-9b9cfac00e19	2026-01-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201003 application number: ANDA201003
RISPERIDONE	RISPERIDONE	REMEDYREPACK INC.	ee7d6779-7421-4761-99d2-ccbfde9385a8	2026-01-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201003 application number: ANDA201003
RISPERIDONE	RISPERIDONE	REMEDYREPACK INC.	101b2d4d-4740-4225-94bc-aecc05d82c6b	2026-01-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201003 application number: ANDA201003
RISPERIDONE	RISPERIDONE	Ajanta Pharma USA Inc.	095630bd-a77e-434e-94ee-f13da445d8f2	2025-09-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201003 application number: ANDA201003
RISPERIDONE	RISPERIDONE	PD-Rx Pharmaceuticals, Inc.	be388943-fe0c-4c82-ac8e-3df9f77b2891	2025-04-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201003 application number: ANDA201003
Risperidone	RISPERIDONE	Direct_Rx	0b784f21-fc02-6542-e063-6294a90a285e	2025-01-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201003 application number: ANDA201003
RISPERIDONE	RISPERIDONE	NuCare Pharmaceuticals,Inc.	79648a52-1364-c25b-e053-2a91aa0a8ea4	2024-06-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201003 application number: ANDA201003
RISPERIDONE	RISPERIDONE	Bryant Ranch Prepack	420cfeef-0061-43b9-9491-dbd6ad866e55	2024-05-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201003 application number: ANDA201003
RISPERIDONE	RISPERIDONE	Bryant Ranch Prepack	aab773b2-a605-4cf8-a301-57e390fe67a6	2024-05-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201003 application number: ANDA201003
RISPERIDONE	RISPERIDONE	Bryant Ranch Prepack	2f83d3e9-04ab-4b24-ad1f-7ed2e784298a	2024-05-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201003 application number: ANDA201003
RISPERIDONE	RISPERIDONE	Bryant Ranch Prepack	e35be034-6275-41fb-bec4-9ae451458701	2024-04-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201003 application number: ANDA201003
RISPERIDONE	RISPERIDONE	A-S Medication Solutions	523d4f99-1d6f-413f-9d6e-2ca430aaac14	2024-01-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201003 application number: ANDA201003
RISPERIDONE	RISPERIDONE	Aphena Pharma Solutions - Tennessee, LLC	bda104ac-1eea-4a1a-836a-24bcc034b90f	2022-11-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201003 application number: ANDA201003

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
312831	risperiDONE 2 MG Oral Tablet	PSN	1097d343-413d-49fc-8bc9-34a1fdc0b643	4
314211	risperiDONE 4 MG Oral Tablet	PSN	1097d343-413d-49fc-8bc9-34a1fdc0b643	4
312831	risperidone 2 MG Oral Tablet	SCD	1097d343-413d-49fc-8bc9-34a1fdc0b643	4
314211	risperidone 4 MG Oral Tablet	SCD	1097d343-413d-49fc-8bc9-34a1fdc0b643	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
64725-0319-1	64725031901	30 in 1 CONTAINER	Historical