INVEGA

Product NDC: 50458-554
11-digit product format: 504580554
Labeler code: 50458
Product ID: 50458-554_3c5e5b30-a841-4dfe-88ce-361806c9275f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: paliperidone
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Janssen Pharmaceuticals, Inc.
Application: NDA021999
Marketing category: NDA
Marketing start: 2009-09-10
Substance: PALIPERIDONE
Active strength: 1.5 mg/1
Pharmacologic classes: Atypical Antipsychotic [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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 package	package	50458-554	50458-554-01	D	Discontinued by firm	2026-08-07
excluded package	package	50458-554	50458-554-10	D	Discontinued by firm	2026-08-07
excluded package	package	50458-554	50458-554-98	D	Discontinued by firm	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 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Package NDC, Snapshot table
Captured / source date	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	50458-554-98	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	50458-554-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	50458-554-98	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	50458-554-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	50458-554-98	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	50458-554-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	50458-554-98	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	50458-554-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	50458-554-98	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	50458-554-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	50458-554-98	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	50458-554-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	50458-554-01	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	50458-554-98	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	50458-554-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	50458-554-98	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	50458-554-01	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	50458-554-98	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	50458-554-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	50458-554-98	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	50458-554-01	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	50458-554-98	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	50458-554-01	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	50458-554-98	`557ba5c1ecfa…`	`9c80585c8c6e…`

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…`

Additional Listing Data#

Finished product: Yes
Brand name base: INVEGA
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PALIPERIDONE	1.5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
838F01T721	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 8 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
672567	Internal RxNorm lookup
672569	Internal RxNorm lookup
672571	Internal RxNorm lookup
686441	Internal RxNorm lookup
686443	Internal RxNorm lookup
686445	Internal RxNorm lookup
866103	Internal RxNorm lookup
866105	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
7b8e5b26-b9e4-4704-921b-3c3c0d159916	Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
50458-554-01	INVEGA	30 in 1 BOTTLE	TABLET, EXTENDED RELEASE	30	43
50458-554-10	INVEGA	10 in 1 BLISTER PACK	TABLET, EXTENDED RELEASE	10	43
50458-554-10	INVEGA	10 in 1 BOX, UNIT-DOSE	TABLET, EXTENDED RELEASE	10	43
50458-554-98	INVEGA	7 in 1 BOTTLE	TABLET, EXTENDED RELEASE	7	43

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50458-554-01	EA - Each	50458-554	cf14bcab-d3d8-4cfb-9126-8fc2743acae3	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 [JANSSEN PHARMACEUTICALS, INC.]	17
paliperidone	ACTIVE MOIETY	838F01T721	INVEGA (PALIPERIDONE) TABLET, EXTENDED RELEASE [JANSSEN PHARMACEUTICALS, INC.]	17
butylated hydroxytoluene	INACTIVE INGREDIENT	1P9D0Z171K	INVEGA (PALIPERIDONE) TABLET, EXTENDED RELEASE [JANSSEN PHARMACEUTICALS, INC.]	17
carnauba wax	INACTIVE INGREDIENT	R12CBM0EIZ	INVEGA (PALIPERIDONE) TABLET, EXTENDED RELEASE [JANSSEN PHARMACEUTICALS, INC.]	17
cellulose acetate	INACTIVE INGREDIENT	3J2P07GVB6	INVEGA (PALIPERIDONE) TABLET, EXTENDED RELEASE [JANSSEN PHARMACEUTICALS, INC.]	17
ferrosoferric oxide	INACTIVE INGREDIENT	XM0M87F357	INVEGA (PALIPERIDONE) TABLET, EXTENDED RELEASE [JANSSEN PHARMACEUTICALS, INC.]	17
hypromelloses	INACTIVE INGREDIENT	3NXW29V3WO	INVEGA (PALIPERIDONE) TABLET, EXTENDED RELEASE [JANSSEN PHARMACEUTICALS, INC.]	17
lactose monohydrate	INACTIVE INGREDIENT	EWQ57Q8I5X	INVEGA (PALIPERIDONE) TABLET, EXTENDED RELEASE [JANSSEN PHARMACEUTICALS, INC.]	17
polyethylene glycols	INACTIVE INGREDIENT	3WJQ0SDW1A	INVEGA (PALIPERIDONE) TABLET, EXTENDED RELEASE [JANSSEN PHARMACEUTICALS, INC.]	17
povidones	INACTIVE INGREDIENT	FZ989GH94E	INVEGA (PALIPERIDONE) TABLET, EXTENDED RELEASE [JANSSEN PHARMACEUTICALS, INC.]	17
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	INVEGA (PALIPERIDONE) TABLET, EXTENDED RELEASE [JANSSEN PHARMACEUTICALS, INC.]	17
sodium chloride	INACTIVE INGREDIENT	451W47IQ8X	INVEGA (PALIPERIDONE) TABLET, EXTENDED RELEASE [JANSSEN PHARMACEUTICALS, INC.]	17
stearic acid	INACTIVE INGREDIENT	4ELV7Z65AP	INVEGA (PALIPERIDONE) TABLET, EXTENDED RELEASE [JANSSEN PHARMACEUTICALS, INC.]	17
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	INVEGA (PALIPERIDONE) TABLET, EXTENDED RELEASE [JANSSEN PHARMACEUTICALS, INC.]	17
triacetin	INACTIVE INGREDIENT	XHX3C3X673	INVEGA (PALIPERIDONE) TABLET, EXTENDED RELEASE [JANSSEN PHARMACEUTICALS, INC.]	17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50458-554	INVEGA (PALIPERIDONE) TABLET, EXTENDED RELEASE [JANSSEN PHARMACEUTICALS, INC.]	40	Current NDC, Legacy NDC, 4 package rows	20250209_7b8e5b26-b9e4-4704-921b-3c3c0d159916.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 ndc (product): 50458-554

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
866105	INVEGA 1.5 MG 24HR Extended Release Oral Tablet	PSN	7b8e5b26-b9e4-4704-921b-3c3c0d159916	43
686441	INVEGA 3 MG 24HR Extended Release Oral Tablet	PSN	7b8e5b26-b9e4-4704-921b-3c3c0d159916	43
686443	INVEGA 6 MG 24HR Extended Release Oral Tablet	PSN	7b8e5b26-b9e4-4704-921b-3c3c0d159916	43
686445	INVEGA 9 MG 24HR Extended Release Oral Tablet	PSN	7b8e5b26-b9e4-4704-921b-3c3c0d159916	43
866103	paliperidone 1.5 MG 24HR Extended Release Oral Tablet	PSN	7b8e5b26-b9e4-4704-921b-3c3c0d159916	43
672567	paliperidone 3 MG 24HR Extended Release Oral Tablet	PSN	7b8e5b26-b9e4-4704-921b-3c3c0d159916	43
672569	paliperidone 6 MG 24HR Extended Release Oral Tablet	PSN	7b8e5b26-b9e4-4704-921b-3c3c0d159916	43
672571	paliperidone 9 MG 24HR Extended Release Oral Tablet	PSN	7b8e5b26-b9e4-4704-921b-3c3c0d159916	43
866105	24 HR paliperidone 1.5 MG Extended Release Oral Tablet [Invega]	SBD	7b8e5b26-b9e4-4704-921b-3c3c0d159916	43
686441	24 HR paliperidone 3 MG Extended Release Oral Tablet [Invega]	SBD	7b8e5b26-b9e4-4704-921b-3c3c0d159916	43
686443	24 HR paliperidone 6 MG Extended Release Oral Tablet [Invega]	SBD	7b8e5b26-b9e4-4704-921b-3c3c0d159916	43
686445	24 HR paliperidone 9 MG Extended Release Oral Tablet [Invega]	SBD	7b8e5b26-b9e4-4704-921b-3c3c0d159916	43
866103	24 HR paliperidone 1.5 MG Extended Release Oral Tablet	SCD	7b8e5b26-b9e4-4704-921b-3c3c0d159916	43
672567	24 HR paliperidone 3 MG Extended Release Oral Tablet	SCD	7b8e5b26-b9e4-4704-921b-3c3c0d159916	43
672569	24 HR paliperidone 6 MG Extended Release Oral Tablet	SCD	7b8e5b26-b9e4-4704-921b-3c3c0d159916	43
672571	24 HR paliperidone 9 MG Extended Release Oral Tablet	SCD	7b8e5b26-b9e4-4704-921b-3c3c0d159916	43
686441	24 HR Invega 3 MG Extended Release Oral Tablet	SY	7b8e5b26-b9e4-4704-921b-3c3c0d159916	43
686443	24 HR Invega 6 MG Extended Release Oral Tablet	SY	7b8e5b26-b9e4-4704-921b-3c3c0d159916	43
686445	24 HR Invega 9 MG Extended Release Oral Tablet	SY	7b8e5b26-b9e4-4704-921b-3c3c0d159916	43
866105	Invega 1.5 MG 24 HR Extended Release Oral Tablet	SY	7b8e5b26-b9e4-4704-921b-3c3c0d159916	43
686441	Invega 3 MG 24 HR Extended Release Oral Tablet	SY	7b8e5b26-b9e4-4704-921b-3c3c0d159916	43
686443	Invega 6 MG 24 HR Extended Release Oral Tablet	SY	7b8e5b26-b9e4-4704-921b-3c3c0d159916	43
686445	Invega 9 MG 24 HR Extended Release Oral Tablet	SY	7b8e5b26-b9e4-4704-921b-3c3c0d159916	43
866103	paliperidone 1.5 MG 24 HR Extended Release Oral Tablet	SY	7b8e5b26-b9e4-4704-921b-3c3c0d159916	43
672567	paliperidone 3 MG 24 HR Extended Release Oral Tablet	SY	7b8e5b26-b9e4-4704-921b-3c3c0d159916	43
672569	paliperidone 6 MG 24 HR Extended Release Oral Tablet	SY	7b8e5b26-b9e4-4704-921b-3c3c0d159916	43
672571	paliperidone 9 MG 24 HR Extended Release Oral Tablet	SY	7b8e5b26-b9e4-4704-921b-3c3c0d159916	43

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50458-554-01	50458055401	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (50458-554-01)		2009-09-10	0000-00-00	No	No	Current
50458-554-10	50458055410	10 BLISTER PACK in 1 BOX, UNIT-DOSE (50458-554-10) > 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK	10 blister pack	2009-09-10	0000-00-00	No	No	Current
50458-554-98	50458055498	7 in 1 BOTTLE						Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
INVEGA	Janssen Pharmaceuticals, Inc. \| Janssen-Cilag Manufacturing, LLC \| Janssen Pharmaceutical Sciences Unlimited Company	2025-01-31	HUMAN PRESCRIPTION DRUG LABEL	43