Risperidone

Product NDC: 33261-849
11-digit product format: 332610849
Labeler code: 33261
Product ID: 33261-849_dcae48af-ca48-4448-92b6-4ad661582bf4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Risperidone
Dosage form: TABLET
Route: ORAL
Labeler: Aidarex Pharmaceuticals LLC
Application: ANDA079088
Marketing category: ANDA
Marketing start: 2009-01-01
Marketing end: 0000-00-00
Substance: RISPERIDONE
Active strength: 1 mg/1
Pharmacologic classes: Atypical Antipsychotic [EPC]
NDC exclude flag: No
Listing certified through: 2019-12-31
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	33261-849		I	Inactivated by FDA	2026-08-03
excluded package	package	33261-849	33261-849-30	I	Inactivated by FDA	2026-08-03
excluded package	package	33261-849	33261-849-60	I	Inactivated by FDA	2026-08-03
excluded package	package	33261-849	33261-849-90	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 2 · 84 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	33261-849-90	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	33261-849-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	33261-849-60	`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	33261-849-90	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	33261-849-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	33261-849-60	`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	33261-849-90	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	33261-849-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	33261-849-60	`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	33261-849-90	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	33261-849-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	33261-849-60	`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	33261-849-90	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	33261-849-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	33261-849-60	`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	33261-849-90	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	33261-849-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	33261-849-60	`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	33261-849-90	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	33261-849-30	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	33261-849-60	`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	33261-849-90	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	33261-849-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	33261-849-60	`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	33261-849-90	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	33261-849-30	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	33261-849-60	`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	33261-849-90	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	33261-849-30	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	33261-849-60	`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	33261-849-90	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	33261-849-30	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	33261-849-60	`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	33261-849-90	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	33261-849-30	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	33261-849-60	`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	33261-849-90	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	33261-849-30	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	33261-849-60	`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	33261-849-90	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	33261-849-30	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	33261-849-60	`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	33261-849-90	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	33261-849-30	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	33261-849-60	`1332a3947898…`	`d4bfe170f9cd…`

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
A079088-001	RISPERIDONE	RISPERIDONE	0.25MG	TABLET / ORAL	AB	2008-10-30
A079088-002	RISPERIDONE	RISPERIDONE	0.5MG	TABLET / ORAL	AB	2008-10-30
A079088-003	RISPERIDONE	RISPERIDONE	1MG	TABLET / ORAL	AB	2008-10-30
A079088-004	RISPERIDONE	RISPERIDONE	2MG	TABLET / ORAL	AB	2008-10-30
A079088-005	RISPERIDONE	RISPERIDONE	3MG	TABLET / ORAL	AB	2008-10-30
A079088-006	RISPERIDONE	RISPERIDONE	4MG	TABLET / ORAL	AB	2008-10-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A079088-001	AB
A079088-002	AB
A079088-003	AB
A079088-004	AB
A079088-005	AB
A079088-006	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	A079088-001	RISPERIDONE	0.25MG	TABLET / ORAL	AB	2008-10-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079088-002	RISPERIDONE	0.5MG	TABLET / ORAL	AB	2008-10-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079088-003	RISPERIDONE	1MG	TABLET / ORAL	AB	2008-10-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079088-004	RISPERIDONE	2MG	TABLET / ORAL	AB	2008-10-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079088-005	RISPERIDONE	3MG	TABLET / ORAL	AB	2008-10-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079088-006	RISPERIDONE	4MG	TABLET / ORAL	AB	2008-10-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079088-001	RISPERIDONE	0.25MG	TABLET / ORAL	AB	2008-10-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079088-002	RISPERIDONE	0.5MG	TABLET / ORAL	AB	2008-10-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079088-003	RISPERIDONE	1MG	TABLET / ORAL	AB	2008-10-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079088-004	RISPERIDONE	2MG	TABLET / ORAL	AB	2008-10-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079088-005	RISPERIDONE	3MG	TABLET / ORAL	AB	2008-10-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079088-006	RISPERIDONE	4MG	TABLET / ORAL	AB	2008-10-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079088-001	RISPERIDONE	0.25MG	TABLET / ORAL	AB	2008-10-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079088-002	RISPERIDONE	0.5MG	TABLET / ORAL	AB	2008-10-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079088-003	RISPERIDONE	1MG	TABLET / ORAL	AB	2008-10-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079088-004	RISPERIDONE	2MG	TABLET / ORAL	AB	2008-10-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079088-005	RISPERIDONE	3MG	TABLET / ORAL	AB	2008-10-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079088-006	RISPERIDONE	4MG	TABLET / ORAL	AB	2008-10-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079088-001	RISPERIDONE	0.25MG	TABLET / ORAL	AB	2008-10-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079088-002	RISPERIDONE	0.5MG	TABLET / ORAL	AB	2008-10-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079088-003	RISPERIDONE	1MG	TABLET / ORAL	AB	2008-10-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079088-004	RISPERIDONE	2MG	TABLET / ORAL	AB	2008-10-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079088-005	RISPERIDONE	3MG	TABLET / ORAL	AB	2008-10-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079088-006	RISPERIDONE	4MG	TABLET / ORAL	AB	2008-10-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079088-001	RISPERIDONE	0.25MG	TABLET / ORAL	AB	2008-10-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079088-002	RISPERIDONE	0.5MG	TABLET / ORAL	AB	2008-10-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079088-003	RISPERIDONE	1MG	TABLET / ORAL	AB	2008-10-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079088-004	RISPERIDONE	2MG	TABLET / ORAL	AB	2008-10-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079088-005	RISPERIDONE	3MG	TABLET / ORAL	AB	2008-10-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079088-006	RISPERIDONE	4MG	TABLET / ORAL	AB	2008-10-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079088-001	RISPERIDONE	0.25MG	TABLET / ORAL	AB	2008-10-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079088-002	RISPERIDONE	0.5MG	TABLET / ORAL	AB	2008-10-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079088-003	RISPERIDONE	1MG	TABLET / ORAL	AB	2008-10-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079088-004	RISPERIDONE	2MG	TABLET / ORAL	AB	2008-10-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079088-005	RISPERIDONE	3MG	TABLET / ORAL	AB	2008-10-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079088-006	RISPERIDONE	4MG	TABLET / ORAL	AB	2008-10-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079088-001	RISPERIDONE	0.25MG	TABLET / ORAL	AB	2008-10-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079088-002	RISPERIDONE	0.5MG	TABLET / ORAL	AB	2008-10-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079088-003	RISPERIDONE	1MG	TABLET / ORAL	AB	2008-10-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079088-004	RISPERIDONE	2MG	TABLET / ORAL	AB	2008-10-30	`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	A079088-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079088-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079088-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079088-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079088-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079088-006	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079088-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079088-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079088-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079088-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079088-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079088-006	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079088-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079088-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079088-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079088-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079088-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079088-006	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079088-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079088-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079088-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079088-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079088-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079088-006	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079088-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079088-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079088-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079088-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079088-005	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079088-006	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079088-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079088-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079088-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079088-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079088-005	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079088-006	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079088-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079088-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079088-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079088-004	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
33261-849-30	2020-01-31	C162847	48780-1	9d75b9d0-fa93-f424-e053-dadaa90a57ce	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
33261-849-60	2020-01-31	C162847	48780-1	9d75b9d0-fa93-f424-e053-dadaa90a57ce	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
33261-849-90	2020-01-31	C162847	48780-1	9d75b9d0-fa93-f424-e053-dadaa90a57ce	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	SPL version
33261-849-30	Risperidone	30 in 1 BOTTLE, PLASTIC	TABLET	30	1
33261-849-60	Risperidone	60 in 1 BOTTLE, PLASTIC	TABLET	60	1
33261-849-90	Risperidone	90 in 1 BOTTLE, PLASTIC	TABLET	90	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
33261-849-30	EA - Each	33261-849	b2942503-e1a1-46d2-803f-42b18c890e55	1	2015-10-02
33261-849-60	EA - Each	33261-849	965ab303-1258-477e-8836-555bbe4fe2a2	1	2015-10-02
33261-849-90	EA - Each	33261-849	e57601e6-23bb-4d30-8413-0791446667ed	1	2015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
RISPERIDONE	ACTIVE INGREDIENT	L6UH7ZF8HC	RISPERIDONE TABLET [AIDAREX PHARMACEUTICALS LLC]	1
RISPERIDONE	ACTIVE MOIETY	L6UH7ZF8HC	RISPERIDONE TABLET [AIDAREX PHARMACEUTICALS LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
33261-849	RISPERIDONE TABLET [AIDAREX PHARMACEUTICALS LLC]	1	Legacy NDC, 3 package rows	20140213_c0a1be95-f691-4e0f-8d4e-ae7e26a00f1f.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Risperidone	RISPERIDONE	PD-Rx Pharmaceuticals, Inc.	e72a2768-815f-47bf-b2f9-16a93dd10684	2026-04-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079088 application number: ANDA079088
Risperidone	RISPERIDONE	Torrent Pharmaceuticals Limited	a6347895-5f16-43b4-92a0-b9904ac81937	2026-03-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079088 application number: ANDA079088

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
312830	risperiDONE 1 MG Oral Tablet	PSN	c0a1be95-f691-4e0f-8d4e-ae7e26a00f1f	1
312830	risperidone 1 MG Oral Tablet	SCD	c0a1be95-f691-4e0f-8d4e-ae7e26a00f1f	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
33261-849-30	33261084930	30 in 1 BOTTLE, PLASTIC	Historical
33261-849-60	33261084960	60 in 1 BOTTLE, PLASTIC	Historical
33261-849-90	33261084990	90 in 1 BOTTLE, PLASTIC	Historical