RISPERDAL

Product NDC: 21695-115
11-digit product format: 216950115
Labeler code: 21695
Product ID: 21695-115_fca1c3cd-45f3-45cc-bb1d-656c65e91c8a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: risperidone
Dosage form: TABLET
Route: ORAL
Labeler: Rebel Distributors Corp
Application: NDA020272
Marketing category: NDA
Marketing start: 1993-12-29
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	21695-115		I	Inactivated by FDA	2026-10-28
excluded package	package	21695-115	21695-115-30	I	Inactivated by FDA	2026-10-28
excluded package	package	21695-115	21695-115-60	I	Inactivated by FDA	2026-10-28

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 · 66 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	21695-115-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	21695-115-30	`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	21695-115-60	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	21695-115-30	`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	21695-115-60	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	21695-115-30	`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	21695-115-60	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	21695-115-30	`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	21695-115-60	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	21695-115-30	`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	21695-115-60	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	21695-115-30	`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	21695-115-60	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	21695-115-30	`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	21695-115-60	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	21695-115-30	`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	21695-115-60	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	21695-115-30	`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	21695-115-60	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	21695-115-30	`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	21695-115-60	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	21695-115-30	`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	21695-115-60	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	21695-115-30	`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	21695-115-60	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	21695-115-30	`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	21695-115-60	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	21695-115-30	`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	21695-115-60	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	21695-115-30	`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	21695-115-60	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	21695-115-30	`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	21695-115-60	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	21695-115-30	`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	21695-115-60	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	21695-115-30	`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	21695-115-60	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	21695-115-30	`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	21695-115-60	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	21695-115-30	`e2bbac7714bc…`	`27bdfed8d636…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 7 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N020272-001	RISPERDAL	RISPERIDONE	1MG	TABLET / ORAL	AB	RLD, RS	1993-12-29
N020272-002	RISPERDAL	RISPERIDONE	2MG	TABLET / ORAL	AB	RLD	1993-12-29
N020272-003	RISPERDAL	RISPERIDONE	3MG	TABLET / ORAL	AB	RLD	1993-12-29
N020272-004	RISPERDAL	RISPERIDONE	4MG	TABLET / ORAL	AB	RLD	1993-12-29
N020272-005	RISPERDAL	RISPERIDONE	5MG	TABLET / ORAL			1993-12-29
N020272-007	RISPERDAL	RISPERIDONE	0.5MG	TABLET / ORAL	AB	RLD	1999-01-27
N020272-008	RISPERDAL	RISPERIDONE	0.25MG	TABLET / ORAL	AB	RLD	1999-05-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N020272-001	AB
N020272-002	AB
N020272-003	AB
N020272-004	AB
N020272-007	AB
N020272-008	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 8 · 308 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	N020272-001	RISPERDAL	1MG	TABLET / ORAL	AB	RLD, RS	1993-12-29	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N020272-002	RISPERDAL	2MG	TABLET / ORAL	AB	RLD	1993-12-29	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N020272-003	RISPERDAL	3MG	TABLET / ORAL	AB	RLD	1993-12-29	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N020272-004	RISPERDAL	4MG	TABLET / ORAL	AB	RLD	1993-12-29	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N020272-005	RISPERDAL	5MG	TABLET / ORAL			1993-12-29	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N020272-007	RISPERDAL	0.5MG	TABLET / ORAL	AB	RLD	1999-01-27	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N020272-008	RISPERDAL	0.25MG	TABLET / ORAL	AB	RLD	1999-05-10	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N020272-001	RISPERDAL	1MG	TABLET / ORAL	AB	RLD, RS	1993-12-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020272-002	RISPERDAL	2MG	TABLET / ORAL	AB	RLD	1993-12-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020272-003	RISPERDAL	3MG	TABLET / ORAL	AB	RLD	1993-12-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020272-004	RISPERDAL	4MG	TABLET / ORAL	AB	RLD	1993-12-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020272-005	RISPERDAL	5MG	TABLET / ORAL			1993-12-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020272-007	RISPERDAL	0.5MG	TABLET / ORAL	AB	RLD	1999-01-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020272-008	RISPERDAL	0.25MG	TABLET / ORAL	AB	RLD	1999-05-10	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N020272-001	RISPERDAL	1MG	TABLET / ORAL	AB	RLD, RS	1993-12-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020272-002	RISPERDAL	2MG	TABLET / ORAL	AB	RLD	1993-12-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020272-003	RISPERDAL	3MG	TABLET / ORAL	AB	RLD	1993-12-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020272-004	RISPERDAL	4MG	TABLET / ORAL	AB	RLD	1993-12-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020272-005	RISPERDAL	5MG	TABLET / ORAL			1993-12-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020272-007	RISPERDAL	0.5MG	TABLET / ORAL	AB	RLD	1999-01-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020272-008	RISPERDAL	0.25MG	TABLET / ORAL	AB	RLD	1999-05-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020272-001	RISPERDAL	1MG	TABLET / ORAL	AB	RLD, RS	1993-12-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020272-002	RISPERDAL	2MG	TABLET / ORAL	AB	RLD	1993-12-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020272-003	RISPERDAL	3MG	TABLET / ORAL	AB	RLD	1993-12-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020272-004	RISPERDAL	4MG	TABLET / ORAL	AB	RLD	1993-12-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020272-005	RISPERDAL	5MG	TABLET / ORAL			1993-12-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020272-007	RISPERDAL	0.5MG	TABLET / ORAL	AB	RLD	1999-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020272-008	RISPERDAL	0.25MG	TABLET / ORAL	AB	RLD	1999-05-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020272-001	RISPERDAL	1MG	TABLET / ORAL	AB	RLD, RS	1993-12-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020272-002	RISPERDAL	2MG	TABLET / ORAL	AB	RLD	1993-12-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020272-003	RISPERDAL	3MG	TABLET / ORAL	AB	RLD	1993-12-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020272-004	RISPERDAL	4MG	TABLET / ORAL	AB	RLD	1993-12-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020272-005	RISPERDAL	5MG	TABLET / ORAL			1993-12-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020272-007	RISPERDAL	0.5MG	TABLET / ORAL	AB	RLD	1999-01-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020272-008	RISPERDAL	0.25MG	TABLET / ORAL	AB	RLD	1999-05-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020272-001	RISPERDAL	1MG	TABLET / ORAL	AB	RLD, RS	1993-12-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020272-002	RISPERDAL	2MG	TABLET / ORAL	AB	RLD	1993-12-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020272-003	RISPERDAL	3MG	TABLET / ORAL	AB	RLD	1993-12-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020272-004	RISPERDAL	4MG	TABLET / ORAL	AB	RLD	1993-12-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020272-005	RISPERDAL	5MG	TABLET / ORAL			1993-12-29	`6a471c1ec25d…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 264 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	N020272-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N020272-002	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N020272-003	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N020272-004	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N020272-007	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N020272-008	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N020272-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020272-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020272-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020272-004	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020272-007	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020272-008	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N020272-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020272-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020272-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020272-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020272-007	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020272-008	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020272-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020272-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020272-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020272-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020272-007	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020272-008	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020272-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020272-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020272-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020272-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020272-007	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020272-008	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020272-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020272-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020272-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020272-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020272-007	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020272-008	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020272-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020272-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020272-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020272-004	AB	1	`fd3edfee7708…`

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
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
21695-115-30	2019-09-24	C162847	48780-1	934fe258-4c47-48b1-e053-8cdaa90a720a	These highlights do not include all the information needed to use RISPERDAL ® safely and effectively. See full prescribing information for RISPERDAL ® . RISPERDAL ® (risperidone) tablets, RISPERDAL® (risperidone) oral solution, RISPERDAL ® M-TAB ® (risperidone) orally disintegrating tablets Initial U.S. Approval: 1993
21695-115-60	2019-09-24	C162847	48780-1	934fe258-4c47-48b1-e053-8cdaa90a720a	These highlights do not include all the information needed to use RISPERDAL ® safely and effectively. See full prescribing information for RISPERDAL ® . RISPERDAL ® (risperidone) tablets, RISPERDAL® (risperidone) oral solution, RISPERDAL ® M-TAB ® (risperidone) orally disintegrating tablets Initial U.S. Approval: 1993

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
21695-115-30	RISPERDAL	30 in 1 BOTTLE	TABLET	30		2
21695-115-60	RISPERDAL	60 in 1 BOTTLE	TABLET	60		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
21695-115-30	EA - Each	21695-115	98ac321c-8cfc-42be-ab35-7899b9df60a4	1	2012-07-24
21695-115-60	EA - Each	21695-115	9363e9c3-6d3e-4508-b851-a24e98c08682	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
risperidone	ACTIVE INGREDIENT	L6UH7ZF8HC	RISPERDAL (RISPERIDONE) TABLET [REBEL DISTRIBUTORS CORP]	2
risperidone	ACTIVE MOIETY	L6UH7ZF8HC	RISPERDAL (RISPERIDONE) TABLET [REBEL DISTRIBUTORS CORP]	2
anhydrous lactose	INACTIVE INGREDIENT	3SY5LH9PMK	RISPERDAL (RISPERIDONE) TABLET [REBEL DISTRIBUTORS CORP]	2
cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	RISPERDAL (RISPERIDONE) TABLET [REBEL DISTRIBUTORS CORP]	2
D&C Yellow No. 10	INACTIVE INGREDIENT	35SW5USQ3G	RISPERDAL (RISPERIDONE) TABLET [REBEL DISTRIBUTORS CORP]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	RISPERDAL (RISPERIDONE) TABLET [REBEL DISTRIBUTORS CORP]	2
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	RISPERDAL (RISPERIDONE) TABLET [REBEL DISTRIBUTORS CORP]	2
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	RISPERDAL (RISPERIDONE) TABLET [REBEL DISTRIBUTORS CORP]	2
silicon dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	RISPERDAL (RISPERIDONE) TABLET [REBEL DISTRIBUTORS CORP]	2
sodium lauryl sulfate	INACTIVE INGREDIENT	368GB5141J	RISPERDAL (RISPERIDONE) TABLET [REBEL DISTRIBUTORS CORP]	2
starch, corn	INACTIVE INGREDIENT	O8232NY3SJ	RISPERDAL (RISPERIDONE) TABLET [REBEL DISTRIBUTORS CORP]	2
talc	INACTIVE INGREDIENT	7SEV7J4R1U	RISPERDAL (RISPERIDONE) TABLET [REBEL DISTRIBUTORS CORP]	2
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	RISPERDAL (RISPERIDONE) TABLET [REBEL DISTRIBUTORS CORP]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
21695-115	RISPERDAL (RISPERIDONE) TABLET [REBEL DISTRIBUTORS CORP]	2	Legacy NDC, 2 package rows	20110815_01859e07-1262-4cc6-b7ed-5a273cbf0c36.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
104781	RisperDAL 1 MG Oral Tablet	PSN	01859e07-1262-4cc6-b7ed-5a273cbf0c36	2
104783	RisperDAL 3 MG Oral Tablet	PSN	01859e07-1262-4cc6-b7ed-5a273cbf0c36	2
312830	risperiDONE 1 MG Oral Tablet	PSN	01859e07-1262-4cc6-b7ed-5a273cbf0c36	2
312832	risperiDONE 3 MG Oral Tablet	PSN	01859e07-1262-4cc6-b7ed-5a273cbf0c36	2
104781	risperidone 1 MG Oral Tablet [Risperdal]	SBD	01859e07-1262-4cc6-b7ed-5a273cbf0c36	2
104783	risperidone 3 MG Oral Tablet [Risperdal]	SBD	01859e07-1262-4cc6-b7ed-5a273cbf0c36	2
312830	risperidone 1 MG Oral Tablet	SCD	01859e07-1262-4cc6-b7ed-5a273cbf0c36	2
312832	risperidone 3 MG Oral Tablet	SCD	01859e07-1262-4cc6-b7ed-5a273cbf0c36	2
104781	Risperdal 1 MG Oral Tablet	SY	01859e07-1262-4cc6-b7ed-5a273cbf0c36	2
104783	Risperdal 3 MG Oral Tablet	SY	01859e07-1262-4cc6-b7ed-5a273cbf0c36	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
21695-115-30	21695011530	30 in 1 BOTTLE	Historical
21695-115-60	21695011560	60 in 1 BOTTLE	Historical