Risperidone

Product NDC: 13107-122
11-digit product format: 131070122
Labeler code: 13107
Product ID: 13107-122_a8e32e4d-cb0a-491b-acbd-2627068e3a70
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Risperidone
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Aurolife Pharma LLC
Application: ANDA078269
Marketing category: ANDA
Marketing start: 2009-10-25
Marketing end: 0000-00-00
Substance: RISPERIDONE
Active strength: 2 mg/1
Pharmacologic classes: Atypical Antipsychotic [EPC]
NDC exclude flag: E
Listing certified through: 2018-12-31
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	13107-122		I	Inactivated by FDA	2026-10-05
excluded package	package	13107-122	13107-122-05	I	Inactivated by FDA	2026-10-05
excluded package	package	13107-122	13107-122-10	I	Inactivated by FDA	2026-10-05
excluded package	package	13107-122	13107-122-60	I	Inactivated by FDA	2026-10-05

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 · 88 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	13107-122-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	13107-122-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	13107-122-05	`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	13107-122-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	13107-122-60	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	13107-122-05	`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	13107-122-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	13107-122-60	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	13107-122-05	`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	13107-122-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	13107-122-60	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	13107-122-05	`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	13107-122-10	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	13107-122-60	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	13107-122-05	`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	13107-122-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	13107-122-60	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	13107-122-05	`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	13107-122-10	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	13107-122-60	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	13107-122-05	`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	13107-122-10	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	13107-122-60	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	13107-122-05	`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	13107-122-10	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	13107-122-60	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	13107-122-05	`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	13107-122-10	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	13107-122-60	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	13107-122-05	`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	13107-122-10	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	13107-122-60	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	13107-122-05	`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	13107-122-10	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	13107-122-60	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	13107-122-05	`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	13107-122-10	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	13107-122-60	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	13107-122-05	`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	13107-122-10	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	13107-122-60	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	13107-122-05	`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	13107-122-10	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	13107-122-60	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	13107-122-05	`1332a3947898…`	`d4bfe170f9cd…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A078269-001	RISPERIDONE	RISPERIDONE	0.25MG	TABLET / ORAL	AB	2008-10-08
A078269-002	RISPERIDONE	RISPERIDONE	0.5MG	TABLET / ORAL	AB	2008-10-08
A078269-003	RISPERIDONE	RISPERIDONE	1MG	TABLET / ORAL	AB	2008-10-08
A078269-004	RISPERIDONE	RISPERIDONE	2MG	TABLET / ORAL	AB	2008-10-08
A078269-005	RISPERIDONE	RISPERIDONE	3MG	TABLET / ORAL	AB	2008-10-08
A078269-006	RISPERIDONE	RISPERIDONE	4MG	TABLET / ORAL	AB	2008-10-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078269-001	AB
A078269-002	AB
A078269-003	AB
A078269-004	AB
A078269-005	AB
A078269-006	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 · 258 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
2026-09-14 22:38:34	2026-08	A078269-001	RISPERIDONE	0.25MG	TABLET / ORAL	AB	2008-10-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078269-002	RISPERIDONE	0.5MG	TABLET / ORAL	AB	2008-10-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078269-003	RISPERIDONE	1MG	TABLET / ORAL	AB	2008-10-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078269-004	RISPERIDONE	2MG	TABLET / ORAL	AB	2008-10-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078269-005	RISPERIDONE	3MG	TABLET / ORAL	AB	2008-10-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078269-006	RISPERIDONE	4MG	TABLET / ORAL	AB	2008-10-08	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078269-001	RISPERIDONE	0.25MG	TABLET / ORAL	AB	2008-10-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078269-002	RISPERIDONE	0.5MG	TABLET / ORAL	AB	2008-10-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078269-003	RISPERIDONE	1MG	TABLET / ORAL	AB	2008-10-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078269-004	RISPERIDONE	2MG	TABLET / ORAL	AB	2008-10-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078269-005	RISPERIDONE	3MG	TABLET / ORAL	AB	2008-10-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078269-006	RISPERIDONE	4MG	TABLET / ORAL	AB	2008-10-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078269-001	RISPERIDONE	0.25MG	TABLET / ORAL	AB	2008-10-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078269-002	RISPERIDONE	0.5MG	TABLET / ORAL	AB	2008-10-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078269-003	RISPERIDONE	1MG	TABLET / ORAL	AB	2008-10-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078269-004	RISPERIDONE	2MG	TABLET / ORAL	AB	2008-10-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078269-005	RISPERIDONE	3MG	TABLET / ORAL	AB	2008-10-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078269-006	RISPERIDONE	4MG	TABLET / ORAL	AB	2008-10-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078269-001	RISPERIDONE	0.25MG	TABLET / ORAL	AB	2008-10-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078269-002	RISPERIDONE	0.5MG	TABLET / ORAL	AB	2008-10-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078269-003	RISPERIDONE	1MG	TABLET / ORAL	AB	2008-10-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078269-004	RISPERIDONE	2MG	TABLET / ORAL	AB	2008-10-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078269-005	RISPERIDONE	3MG	TABLET / ORAL	AB	2008-10-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078269-006	RISPERIDONE	4MG	TABLET / ORAL	AB	2008-10-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078269-001	RISPERIDONE	0.25MG	TABLET / ORAL	AB	2008-10-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078269-002	RISPERIDONE	0.5MG	TABLET / ORAL	AB	2008-10-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078269-003	RISPERIDONE	1MG	TABLET / ORAL	AB	2008-10-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078269-004	RISPERIDONE	2MG	TABLET / ORAL	AB	2008-10-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078269-005	RISPERIDONE	3MG	TABLET / ORAL	AB	2008-10-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078269-006	RISPERIDONE	4MG	TABLET / ORAL	AB	2008-10-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078269-001	RISPERIDONE	0.25MG	TABLET / ORAL	AB	2008-10-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078269-002	RISPERIDONE	0.5MG	TABLET / ORAL	AB	2008-10-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078269-003	RISPERIDONE	1MG	TABLET / ORAL	AB	2008-10-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078269-004	RISPERIDONE	2MG	TABLET / ORAL	AB	2008-10-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078269-005	RISPERIDONE	3MG	TABLET / ORAL	AB	2008-10-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078269-006	RISPERIDONE	4MG	TABLET / ORAL	AB	2008-10-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078269-001	RISPERIDONE	0.25MG	TABLET / ORAL	AB	2008-10-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078269-002	RISPERIDONE	0.5MG	TABLET / ORAL	AB	2008-10-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078269-003	RISPERIDONE	1MG	TABLET / ORAL	AB	2008-10-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078269-004	RISPERIDONE	2MG	TABLET / ORAL	AB	2008-10-08	`b8a1b40f171c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 258 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A078269-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078269-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078269-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078269-004	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078269-005	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078269-006	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078269-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078269-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078269-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078269-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078269-005	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078269-006	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078269-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078269-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078269-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078269-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078269-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078269-006	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078269-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078269-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078269-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078269-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078269-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078269-006	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078269-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078269-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078269-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078269-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078269-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078269-006	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078269-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078269-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078269-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078269-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078269-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078269-006	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078269-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078269-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078269-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078269-004	AB	1	`b8a1b40f171c…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
13107-122-05	2020-01-31	C162847	48780-1	9d75b9d0-1960-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use risperidone safely and effectively. See full prescribing information for risperidone tablets, USP. Risperidone Tablets, USP Initial U.S. Approval: 1993
13107-122-10	2020-01-31	C162847	48780-1	9d75b9d0-1960-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use risperidone safely and effectively. See full prescribing information for risperidone tablets, USP. Risperidone Tablets, USP Initial U.S. Approval: 1993
13107-122-60	2020-01-31	C162847	48780-1	9d75b9d0-1960-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use risperidone safely and effectively. See full prescribing information for risperidone tablets, USP. Risperidone Tablets, USP Initial U.S. Approval: 1993

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
13107-122-05	Risperidone	500 in 1 BOTTLE	TABLET, FILM COATED	500	3
13107-122-10	Risperidone	10 in 1 BLISTER PACK	TABLET, FILM COATED	10	3
13107-122-10	Risperidone	10 in 1 CARTON	TABLET, FILM COATED	10	3
13107-122-60	Risperidone	60 in 1 BOTTLE	TABLET, FILM COATED	60	3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
13107-122-05	EA - Each	13107-122	ebc3f9ee-5097-43a9-8b26-e5a8519fe417	1	2012-07-24
13107-122-60	EA - Each	13107-122	8ce365f6-8561-4e17-9e9e-bce750d1c322	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
RISPERIDONE	ACTIVE INGREDIENT	L6UH7ZF8HC	RISPERIDONE TABLET, FILM COATED [AUROLIFE PHARMA LLC]	3
RISPERIDONE	ACTIVE MOIETY	L6UH7ZF8HC	RISPERIDONE TABLET, FILM COATED [AUROLIFE PHARMA LLC]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	RISPERIDONE TABLET, FILM COATED [AUROLIFE PHARMA LLC]	3
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	RISPERIDONE TABLET, FILM COATED [AUROLIFE PHARMA LLC]	3
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	RISPERIDONE TABLET, FILM COATED [AUROLIFE PHARMA LLC]	3
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	RISPERIDONE TABLET, FILM COATED [AUROLIFE PHARMA LLC]	3
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	RISPERIDONE TABLET, FILM COATED [AUROLIFE PHARMA LLC]	3
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	RISPERIDONE TABLET, FILM COATED [AUROLIFE PHARMA LLC]	3
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	RISPERIDONE TABLET, FILM COATED [AUROLIFE PHARMA LLC]	3
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	RISPERIDONE TABLET, FILM COATED [AUROLIFE PHARMA LLC]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	RISPERIDONE TABLET, FILM COATED [AUROLIFE PHARMA LLC]	3
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	RISPERIDONE TABLET, FILM COATED [AUROLIFE PHARMA LLC]	3
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	RISPERIDONE TABLET, FILM COATED [AUROLIFE PHARMA LLC]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	RISPERIDONE TABLET, FILM COATED [AUROLIFE PHARMA LLC]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
13107-122	RISPERIDONE TABLET, FILM COATED [AUROLIFE PHARMA LLC]	3	Legacy NDC, 4 package rows	20120515_24a02cd6-667c-4e03-8055-aaa094567864.zip

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
312828	risperiDONE 0.25 MG Oral Tablet	PSN	24a02cd6-667c-4e03-8055-aaa094567864	3
312829	risperiDONE 0.5 MG Oral Tablet	PSN	24a02cd6-667c-4e03-8055-aaa094567864	3
312830	risperiDONE 1 MG Oral Tablet	PSN	24a02cd6-667c-4e03-8055-aaa094567864	3
312831	risperiDONE 2 MG Oral Tablet	PSN	24a02cd6-667c-4e03-8055-aaa094567864	3
312832	risperiDONE 3 MG Oral Tablet	PSN	24a02cd6-667c-4e03-8055-aaa094567864	3
314211	risperiDONE 4 MG Oral Tablet	PSN	24a02cd6-667c-4e03-8055-aaa094567864	3
312828	risperidone 0.25 MG Oral Tablet	SCD	24a02cd6-667c-4e03-8055-aaa094567864	3
312829	risperidone 0.5 MG Oral Tablet	SCD	24a02cd6-667c-4e03-8055-aaa094567864	3
312830	risperidone 1 MG Oral Tablet	SCD	24a02cd6-667c-4e03-8055-aaa094567864	3
312831	risperidone 2 MG Oral Tablet	SCD	24a02cd6-667c-4e03-8055-aaa094567864	3
312832	risperidone 3 MG Oral Tablet	SCD	24a02cd6-667c-4e03-8055-aaa094567864	3
314211	risperidone 4 MG Oral Tablet	SCD	24a02cd6-667c-4e03-8055-aaa094567864	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
13107-122-05	13107012205	500 in 1 BOTTLE	Historical
13107-122-10	13107012210	10 in 1 BLISTER PACK	Historical
13107-122-60	13107012260	60 in 1 BOTTLE	Historical