INVEGA

Product NDC: 21695-455
11-digit product format: 216950455
Labeler code: 21695
Product ID: 21695-455_8de6a6eb-9ed8-4e05-9a4c-d657b5634f76
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: paliperidone
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Rebel Distributors Corp
Application: NDA021999
Marketing category: NDA
Marketing start: 2006-12-19
Marketing end: 0000-00-00
Substance: PALIPERIDONE
Active strength: 6 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	21695-455		I	Inactivated by FDA		2026-08-07
excluded package	package	21695-455	21695-455-30	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 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	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	21695-455-30	`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	21695-455-30	`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	21695-455-30	`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	21695-455-30	`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	21695-455-30	`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	21695-455-30	`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	21695-455-30	`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	21695-455-30	`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	21695-455-30	`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	21695-455-30	`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	21695-455-30	`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	21695-455-30	`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	21695-455-30	`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	21695-455-30	`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	21695-455-30	`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	21695-455-30	`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	21695-455-30	`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	21695-455-30	`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	21695-455-30	`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	21695-455-30	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	21695-455-30	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	21695-455-30	`110d247fa046…`	`a55b01930146…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021999-001	INVEGA	PALIPERIDONE	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2006-12-19
N021999-002	INVEGA	PALIPERIDONE	6MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2006-12-19
N021999-003	INVEGA	PALIPERIDONE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2006-12-19
N021999-004	INVEGA	PALIPERIDONE	12MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD	2006-12-19
N021999-006	INVEGA	PALIPERIDONE	1.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD	2008-08-26

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
N021999-001	AB
N021999-002	AB
N021999-003	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 6 · 205 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	N021999-001	INVEGA	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2006-12-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021999-002	INVEGA	6MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2006-12-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021999-003	INVEGA	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2006-12-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021999-004	INVEGA	12MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD	2006-12-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021999-006	INVEGA	1.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD	2008-08-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021999-001	INVEGA	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2006-12-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021999-002	INVEGA	6MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2006-12-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021999-003	INVEGA	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2006-12-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021999-004	INVEGA	12MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD	2006-12-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021999-006	INVEGA	1.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD	2008-08-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021999-001	INVEGA	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2006-12-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021999-002	INVEGA	6MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2006-12-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021999-003	INVEGA	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2006-12-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021999-004	INVEGA	12MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD	2006-12-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021999-006	INVEGA	1.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD	2008-08-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021999-001	INVEGA	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2006-12-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021999-002	INVEGA	6MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2006-12-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021999-003	INVEGA	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2006-12-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021999-004	INVEGA	12MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD	2006-12-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021999-006	INVEGA	1.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD	2008-08-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021999-001	INVEGA	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2006-12-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021999-002	INVEGA	6MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2006-12-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021999-003	INVEGA	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2006-12-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021999-004	INVEGA	12MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD	2006-12-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021999-006	INVEGA	1.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD	2008-08-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021999-001	INVEGA	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2006-12-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021999-002	INVEGA	6MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2006-12-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021999-003	INVEGA	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2006-12-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021999-004	INVEGA	12MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD	2006-12-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021999-006	INVEGA	1.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD	2008-08-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021999-001	INVEGA	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2006-12-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021999-002	INVEGA	6MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2006-12-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021999-003	INVEGA	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2006-12-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021999-004	INVEGA	12MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD	2006-12-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021999-006	INVEGA	1.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD	2008-08-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021999-001	INVEGA	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2006-12-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021999-002	INVEGA	6MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2006-12-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021999-003	INVEGA	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2006-12-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021999-004	INVEGA	12MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD	2006-12-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021999-006	INVEGA	1.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD	2008-08-26	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 149 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	N021999-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021999-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021999-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021999-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021999-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021999-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021999-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021999-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021999-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021999-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021999-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021999-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021999-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021999-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021999-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021999-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021999-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021999-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021999-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021999-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021999-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021999-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021999-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021999-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021999-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021999-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021999-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021999-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021999-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021999-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021999-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021999-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021999-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021999-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021999-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021999-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021999-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021999-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021999-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021999-001	AB	1	`8072bd15b7f6…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
3752075e-d817-45ea-9aa1-8dc0301cf2aa	Product name	1	20251114
893dce58-6330-4a9a-ab03-5ffd7148e184	Product name	1	20250311
b6847380-b533-d626-e29e-10b60b2ad451	Product name	9	20250303
fd328049-536a-4914-b42e-93bf4d93db24	Product name	1	20220307
0f0756fc-4d63-4f75-afcc-9c5e62a38d69	Product name	2	20220304

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
21695-455-30	2019-09-24	C162847	48780-1	934fe258-49c5-48b1-e053-8cdaa90a720a	These highlights do not include all the information needed to use INVEGA ® safely and effectively. See full prescribing information for INVEGA ® . INVEGA ® (paliperidone) Extended-Release Tablets Initial U.S. Approval: 2006

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
21695-455-30	INVEGA	30 in 1 BOTTLE	TABLET, EXTENDED RELEASE	30		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
21695-455-30	EA - Each	21695-455	462923c2-bafb-4a57-95f1-2abcd7be7c07	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
paliperidone	ACTIVE INGREDIENT	838F01T721	INVEGA (PALIPERIDONE) TABLET, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]	1
paliperidone	ACTIVE MOIETY	838F01T721	INVEGA (PALIPERIDONE) TABLET, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]	1
butylated hydroxytoluene	INACTIVE INGREDIENT	1P9D0Z171K	INVEGA (PALIPERIDONE) TABLET, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]	1
carnauba wax	INACTIVE INGREDIENT	R12CBM0EIZ	INVEGA (PALIPERIDONE) TABLET, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]	1
cellulose acetate	INACTIVE INGREDIENT	3J2P07GVB6	INVEGA (PALIPERIDONE) TABLET, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]	1
ferrosoferric oxide	INACTIVE INGREDIENT	XM0M87F357	INVEGA (PALIPERIDONE) TABLET, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	INVEGA (PALIPERIDONE) TABLET, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]	1
polyethylene glycol	INACTIVE INGREDIENT	3WJQ0SDW1A	INVEGA (PALIPERIDONE) TABLET, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]	1
povidone	INACTIVE INGREDIENT	FZ989GH94E	INVEGA (PALIPERIDONE) TABLET, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]	1
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	INVEGA (PALIPERIDONE) TABLET, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]	1
sodium chloride	INACTIVE INGREDIENT	451W47IQ8X	INVEGA (PALIPERIDONE) TABLET, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]	1
stearic acid	INACTIVE INGREDIENT	4ELV7Z65AP	INVEGA (PALIPERIDONE) TABLET, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]	1
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	INVEGA (PALIPERIDONE) TABLET, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
21695-455	INVEGA (PALIPERIDONE) TABLET, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]	1	Legacy NDC, 1 package rows	20110104_8de6a6eb-9ed8-4e05-9a4c-d657b5634f76.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
INVEGA	PALIPERIDONE	Janssen Pharmaceuticals, Inc.	7b8e5b26-b9e4-4704-921b-3c3c0d159916	2025-01-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021999 application number: NDA021999

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
838F01T721	PALIPERIDONE	144598-75-4	PALIPERIDONE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
686443	INVEGA 6 MG 24HR Extended Release Oral Tablet	PSN	8de6a6eb-9ed8-4e05-9a4c-d657b5634f76	1
672569	paliperidone 6 MG 24HR Extended Release Oral Tablet	PSN	8de6a6eb-9ed8-4e05-9a4c-d657b5634f76	1
686443	24 HR paliperidone 6 MG Extended Release Oral Tablet [Invega]	SBD	8de6a6eb-9ed8-4e05-9a4c-d657b5634f76	1
672569	24 HR paliperidone 6 MG Extended Release Oral Tablet	SCD	8de6a6eb-9ed8-4e05-9a4c-d657b5634f76	1
686443	24 HR Invega 6 MG Extended Release Oral Tablet	SY	8de6a6eb-9ed8-4e05-9a4c-d657b5634f76	1
686443	Invega 6 MG 24 HR Extended Release Oral Tablet	SY	8de6a6eb-9ed8-4e05-9a4c-d657b5634f76	1
672569	paliperidone 6 MG 24 HR Extended Release Oral Tablet	SY	8de6a6eb-9ed8-4e05-9a4c-d657b5634f76	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
21695-455-30	21695045530	30 in 1 BOTTLE	Historical