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	2026-08-07
excluded package	package	21695-115	21695-115-30	I	Inactivated by FDA	2026-08-07
excluded package	package	21695-115	21695-115-60	I	Inactivated by FDA	2026-08-07

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 1.

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 · 287 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
2026-02-19 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…`
2025-08-23 18:47 UTC	2025-08	N020272-007	RISPERDAL	0.5MG	TABLET / ORAL	AB	RLD	1999-01-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020272-008	RISPERDAL	0.25MG	TABLET / ORAL	AB	RLD	1999-05-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020272-001	RISPERDAL	1MG	TABLET / ORAL	AB	RLD, RS	1993-12-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020272-002	RISPERDAL	2MG	TABLET / ORAL	AB	RLD	1993-12-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020272-003	RISPERDAL	3MG	TABLET / ORAL	AB	RLD	1993-12-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020272-004	RISPERDAL	4MG	TABLET / ORAL	AB	RLD	1993-12-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020272-005	RISPERDAL	5MG	TABLET / ORAL			1993-12-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020272-007	RISPERDAL	0.5MG	TABLET / ORAL	AB	RLD	1999-01-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020272-008	RISPERDAL	0.25MG	TABLET / ORAL	AB	RLD	1999-05-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020272-001	RISPERDAL	1MG	TABLET / ORAL	AB	RLD, RS	1993-12-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020272-002	RISPERDAL	2MG	TABLET / ORAL	AB	RLD	1993-12-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020272-003	RISPERDAL	3MG	TABLET / ORAL	AB	RLD	1993-12-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020272-004	RISPERDAL	4MG	TABLET / ORAL	AB	RLD	1993-12-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020272-005	RISPERDAL	5MG	TABLET / ORAL			1993-12-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020272-007	RISPERDAL	0.5MG	TABLET / ORAL	AB	RLD	1999-01-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020272-008	RISPERDAL	0.25MG	TABLET / ORAL	AB	RLD	1999-05-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020272-001	RISPERDAL	1MG	TABLET / ORAL	AB	RLD, RS	1993-12-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020272-002	RISPERDAL	2MG	TABLET / ORAL	AB	RLD	1993-12-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020272-003	RISPERDAL	3MG	TABLET / ORAL	AB	RLD	1993-12-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020272-004	RISPERDAL	4MG	TABLET / ORAL	AB	RLD	1993-12-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020272-005	RISPERDAL	5MG	TABLET / ORAL			1993-12-29	`03ed91905a0d…`

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	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…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020272-007	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020272-008	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020272-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020272-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020272-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020272-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020272-007	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020272-008	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020272-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020272-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020272-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020272-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020272-007	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020272-008	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020272-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020272-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020272-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020272-004	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
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

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
RISPERDAL	RISPERIDONE	Janssen Pharmaceuticals, Inc.	7e117c7e-02fc-4343-92a1-230061dfc5e0	2026-05-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 020272 application number: NDA020272

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