Paliperidone

Product NDC: 0378-3978
11-digit product format: 003783978
Labeler code: 0378
Product ID: 0378-3978_222509f8-7c2a-404d-b942-e876b7c636ee
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: paliperidone
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: Mylan Pharmaceuticals Inc.
Application: ANDA203802
Marketing category: ANDA
Marketing start: 2015-09-24
Marketing end: 2023-11-29
Substance: PALIPERIDONE
Active strength: 2 mg/1
Pharmacologic classes: Atypical Antipsychotic [EPC]
NDC exclude flag: No
Listing certified through: 0000-00-00
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	0378-3978		D	Discontinued by firm		2026-08-10
excluded package	package	0378-3978	0378-3978-93	D	Discontinued by firm		2026-08-10

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, 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	0378-3978-93	`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	0378-3978-93	`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	0378-3978-93	`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	0378-3978-93	`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	0378-3978-93	`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	0378-3978-93	`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	0378-3978-93	`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	0378-3978-93	`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	0378-3978-93	`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	0378-3978-93	`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	0378-3978-93	`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	0378-3978-93	`557ba5c1ecfa…`	`9c80585c8c6e…`

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A203802-001	PALIPERIDONE	PALIPERIDONE	1.5MG	TABLET, EXTENDED RELEASE / ORAL	2015-09-24
A203802-002	PALIPERIDONE	PALIPERIDONE	3MG	TABLET, EXTENDED RELEASE / ORAL	2015-09-24
A203802-003	PALIPERIDONE	PALIPERIDONE	6MG	TABLET, EXTENDED RELEASE / ORAL	2015-09-24
A203802-004	PALIPERIDONE	PALIPERIDONE	9MG	TABLET, EXTENDED RELEASE / ORAL	2015-09-24

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 5 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A203802-001	PALIPERIDONE	1.5MG	TABLET, EXTENDED RELEASE / ORAL		2015-09-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203802-002	PALIPERIDONE	3MG	TABLET, EXTENDED RELEASE / ORAL		2015-09-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203802-003	PALIPERIDONE	6MG	TABLET, EXTENDED RELEASE / ORAL		2015-09-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203802-004	PALIPERIDONE	9MG	TABLET, EXTENDED RELEASE / ORAL		2015-09-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203802-001	PALIPERIDONE	1.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-09-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203802-002	PALIPERIDONE	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-09-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203802-003	PALIPERIDONE	6MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-09-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203802-004	PALIPERIDONE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-09-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203802-001	PALIPERIDONE	1.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-09-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203802-002	PALIPERIDONE	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-09-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203802-003	PALIPERIDONE	6MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-09-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203802-004	PALIPERIDONE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-09-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203802-001	PALIPERIDONE	1.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-09-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203802-002	PALIPERIDONE	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-09-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203802-003	PALIPERIDONE	6MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-09-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203802-004	PALIPERIDONE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-09-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203802-001	PALIPERIDONE	1.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-09-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203802-002	PALIPERIDONE	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-09-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203802-003	PALIPERIDONE	6MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-09-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203802-004	PALIPERIDONE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-09-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203802-001	PALIPERIDONE	1.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-09-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203802-002	PALIPERIDONE	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-09-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203802-003	PALIPERIDONE	6MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-09-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203802-004	PALIPERIDONE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-09-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203802-001	PALIPERIDONE	1.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-09-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203802-002	PALIPERIDONE	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-09-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203802-003	PALIPERIDONE	6MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-09-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203802-004	PALIPERIDONE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-09-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203802-001	PALIPERIDONE	1.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-09-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203802-002	PALIPERIDONE	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-09-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203802-003	PALIPERIDONE	6MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-09-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203802-004	PALIPERIDONE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-09-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203802-001	PALIPERIDONE	1.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-09-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203802-002	PALIPERIDONE	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-09-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203802-003	PALIPERIDONE	6MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-09-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203802-004	PALIPERIDONE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-09-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203802-001	PALIPERIDONE	1.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-09-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203802-002	PALIPERIDONE	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-09-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203802-003	PALIPERIDONE	6MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-09-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203802-004	PALIPERIDONE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-09-24	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 156 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203802-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203802-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203802-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203802-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203802-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203802-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203802-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203802-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203802-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203802-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203802-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203802-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203802-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203802-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203802-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203802-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203802-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203802-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203802-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203802-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203802-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203802-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203802-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203802-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203802-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203802-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203802-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203802-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203802-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203802-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203802-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203802-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203802-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203802-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203802-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203802-004	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203802-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203802-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203802-003	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203802-004	AB	1	`79d66fd596c7…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0378-3978-93	EA - Each	0378-3978	1c560dc4-521c-496c-9327-6e4205f2e5d5	1	2015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PALIPERIDONE	ACTIVE INGREDIENT	838F01T721	PALIPERIDONE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	2
PALIPERIDONE	ACTIVE MOIETY	838F01T721	PALIPERIDONE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	2
BUTYLATED HYDROXYTOLUENE	INACTIVE INGREDIENT	1P9D0Z171K	PALIPERIDONE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	2
CELLULOSE ACETATE	INACTIVE INGREDIENT	3J2P07GVB6	PALIPERIDONE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	2
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	PALIPERIDONE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	2
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	PALIPERIDONE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	2
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	PALIPERIDONE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	2
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	PALIPERIDONE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	2
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	PALIPERIDONE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	PALIPERIDONE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	2
POLYDEXTROSE	INACTIVE INGREDIENT	VH2XOU12IE	PALIPERIDONE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	2
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	PALIPERIDONE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	2
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	PALIPERIDONE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	PALIPERIDONE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	PALIPERIDONE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	2
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	PALIPERIDONE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	2
SODIUM STEARYL FUMARATE	INACTIVE INGREDIENT	7CV7WJK4UI	PALIPERIDONE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	PALIPERIDONE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	PALIPERIDONE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	2

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
Paliperidone	PALIPERIDONE	Archis Pharma LLC	e713556e-028e-0f4c-e053-2995a90a9e9f	2025-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203802 application number: ANDA203802

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	Marketing start	Marketing end	Sample	Exclude flag	Status
0378-3978-93	00378397893	30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-3978-93)	2015-09-24	2023-11-29	No	No	Current