Paliperidone

Product NDC: 10147-0954
11-digit product format: 101470954
Labeler code: 10147
Product ID: 10147-0954_ef450fb4-b6a3-11ec-b9d7-d1fdddc23fea
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: paliperidone
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Patriot Pharmaceuticals, LLC
Application: NDA021999
Marketing category: NDA
Marketing start: 2015-09-24
Marketing end: 0000-00-00
Substance: PALIPERIDONE
Active strength: 9 mg/1
Pharmacologic classes: Atypical Antipsychotic [EPC]
NDC exclude flag: No
Listing certified through: 2023-12-31
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	10147-0954		D	Discontinued by firm	2026-08-17
excluded package	package	10147-0954	10147-0954-1	D	Discontinued by firm	2026-08-17
excluded package	package	10147-0954	10147-0954-3	D	Discontinued by firm	2026-08-17

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 · 35 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	10147-0954-3	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	10147-0954-1	`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	10147-0954-3	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	10147-0954-1	`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	10147-0954-3	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	10147-0954-1	`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	10147-0954-3	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	10147-0954-1	`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	10147-0954-3	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	10147-0954-1	`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	10147-0954-3	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	10147-0954-1	`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	10147-0954-3	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	10147-0954-1	`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	10147-0954-3	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	10147-0954-1	`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	10147-0954-3	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	10147-0954-1	`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	10147-0954-3	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	10147-0954-1	`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	10147-0954-3	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	10147-0954-1	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	10147-0954-3	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	10147-0954-1	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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 · 210 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
2026-08-18 06:07:40	2026-07	N021999-001	INVEGA	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2006-12-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021999-002	INVEGA	6MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2006-12-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021999-003	INVEGA	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2006-12-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	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	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	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	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 152 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N021999-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021999-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021999-003	AB	1	`caaa826d4ba7…`
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…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
10147-0954-1	EA - Each	10147-0954	b63407c8-7e40-4565-aed0-232336bc2cdf	1	2015-10-02
10147-0954-3	EA - Each	10147-0954	caf77f92-6cb9-4215-a4b1-7df50fcba16a	1	2015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
paliperidone	ACTIVE INGREDIENT	838F01T721	PALIPERIDONE TABLET, EXTENDED RELEASE [PATRIOT PHARMACEUTICALS, LLC]	1
paliperidone	ACTIVE MOIETY	838F01T721	PALIPERIDONE TABLET, EXTENDED RELEASE [PATRIOT PHARMACEUTICALS, LLC]	1
butylated hydroxytoluene	INACTIVE INGREDIENT	1P9D0Z171K	PALIPERIDONE TABLET, EXTENDED RELEASE [PATRIOT PHARMACEUTICALS, LLC]	1
carnauba wax	INACTIVE INGREDIENT	R12CBM0EIZ	PALIPERIDONE TABLET, EXTENDED RELEASE [PATRIOT PHARMACEUTICALS, LLC]	1
cellulose acetate	INACTIVE INGREDIENT	3J2P07GVB6	PALIPERIDONE TABLET, EXTENDED RELEASE [PATRIOT PHARMACEUTICALS, LLC]	1
ferrosoferric oxide	INACTIVE INGREDIENT	XM0M87F357	PALIPERIDONE TABLET, EXTENDED RELEASE [PATRIOT PHARMACEUTICALS, LLC]	1
hypromelloses	INACTIVE INGREDIENT	3NXW29V3WO	PALIPERIDONE TABLET, EXTENDED RELEASE [PATRIOT PHARMACEUTICALS, LLC]	1
lactose monohydrate	INACTIVE INGREDIENT	EWQ57Q8I5X	PALIPERIDONE TABLET, EXTENDED RELEASE [PATRIOT PHARMACEUTICALS, LLC]	1
polyethylene glycols	INACTIVE INGREDIENT	3WJQ0SDW1A	PALIPERIDONE TABLET, EXTENDED RELEASE [PATRIOT PHARMACEUTICALS, LLC]	1
povidones	INACTIVE INGREDIENT	FZ989GH94E	PALIPERIDONE TABLET, EXTENDED RELEASE [PATRIOT PHARMACEUTICALS, LLC]	1
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	PALIPERIDONE TABLET, EXTENDED RELEASE [PATRIOT PHARMACEUTICALS, LLC]	1
sodium chloride	INACTIVE INGREDIENT	451W47IQ8X	PALIPERIDONE TABLET, EXTENDED RELEASE [PATRIOT PHARMACEUTICALS, LLC]	1
stearic acid	INACTIVE INGREDIENT	4ELV7Z65AP	PALIPERIDONE TABLET, EXTENDED RELEASE [PATRIOT PHARMACEUTICALS, LLC]	1
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	PALIPERIDONE TABLET, EXTENDED RELEASE [PATRIOT PHARMACEUTICALS, LLC]	1
triacetin	INACTIVE INGREDIENT	XHX3C3X673	PALIPERIDONE TABLET, EXTENDED RELEASE [PATRIOT PHARMACEUTICALS, LLC]	1

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
10147-0954-1	10147095401	10 BLISTER PACK in 1 BOX, UNIT-DOSE (10147-0954-1) > 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK	10 blister pack	2015-09-24	0000-00-00	No	No	Current
10147-0954-3	10147095403	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (10147-0954-3)		2015-09-24	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Paliperidone	Patriot Pharmaceuticals, LLC \| Janssen Pharmaceuticals, Inc. \| Janssen Cilag Manufacturing, LLC \| Janssen Pharmaceutical Sciences Unlimited Company	2023-08-17	HUMAN PRESCRIPTION DRUG LABEL	18
Paliperidone	REMEDYREPACK INC.	2019-04-24	HUMAN PRESCRIPTION DRUG LABEL	3