Paliperidone

Product NDC: 72162-2649
11-digit product format: 721622649
Labeler code: 72162
Product ID: 72162-2649_f63cd03e-3a35-414c-95cf-8727d9c5f245
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Paliperidone
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA218755
Marketing category: ANDA
Marketing start: 2025-12-09
Substance: PALIPERIDONE
Active strength: 3 mg/1
Pharmacologic classes: Atypical Antipsychotic [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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	TE codes	Approval date
A218755-001	PALIPERIDONE	PALIPERIDONE	1.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2025-09-04
A218755-002	PALIPERIDONE	PALIPERIDONE	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	2025-09-04
A218755-003	PALIPERIDONE	PALIPERIDONE	6MG	TABLET, EXTENDED RELEASE / ORAL	AB	2025-09-04
A218755-004	PALIPERIDONE	PALIPERIDONE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2025-09-04

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A218755-001	AB
A218755-002	AB
A218755-003	AB
A218755-004	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A218755-001	PALIPERIDONE	1.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2025-09-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A218755-002	PALIPERIDONE	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	2025-09-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A218755-003	PALIPERIDONE	6MG	TABLET, EXTENDED RELEASE / ORAL	AB	2025-09-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A218755-004	PALIPERIDONE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2025-09-04	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A218755-001	PALIPERIDONE	1.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2025-09-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A218755-002	PALIPERIDONE	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	2025-09-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A218755-003	PALIPERIDONE	6MG	TABLET, EXTENDED RELEASE / ORAL	AB	2025-09-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A218755-004	PALIPERIDONE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2025-09-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A218755-001	PALIPERIDONE	1.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2025-09-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218755-002	PALIPERIDONE	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	2025-09-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218755-003	PALIPERIDONE	6MG	TABLET, EXTENDED RELEASE / ORAL	AB	2025-09-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218755-004	PALIPERIDONE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2025-09-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218755-001	PALIPERIDONE	1.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2025-09-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218755-002	PALIPERIDONE	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	2025-09-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218755-003	PALIPERIDONE	6MG	TABLET, EXTENDED RELEASE / ORAL	AB	2025-09-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218755-004	PALIPERIDONE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2025-09-04	`31067a03dcf5…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218755-001	PALIPERIDONE	1.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2025-09-04	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218755-002	PALIPERIDONE	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	2025-09-04	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218755-003	PALIPERIDONE	6MG	TABLET, EXTENDED RELEASE / ORAL	AB	2025-09-04	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218755-004	PALIPERIDONE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2025-09-04	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A218755-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A218755-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A218755-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A218755-004	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A218755-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A218755-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A218755-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A218755-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A218755-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218755-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218755-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218755-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218755-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218755-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218755-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218755-004	AB	1	`31067a03dcf5…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218755-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218755-002	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218755-003	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218755-004	AB	1	`a50c72e98297…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PALIPERIDONE	3 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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
672567	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
c7472b50-fa6c-4127-a4b3-3645436274ee	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
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
fd328049-536a-4914-b42e-93bf4d93db24	Product name	1	20220307
0f0756fc-4d63-4f75-afcc-9c5e62a38d69	Product name	2	20220304
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
72162-2649-3	Paliperidone	30 in 1 BOTTLE	TABLET, EXTENDED RELEASE	30		100

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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Paliperidone	PALIPERIDONE	Bryant Ranch Prepack	ff5ef11c-5c22-4a8e-89dd-4740f0ebf634	2026-05-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 218755 application number: ANDA218755
Paliperidone	PALIPERIDONE	Bryant Ranch Prepack	f75e884e-1883-45d7-ac9b-4a6c63f2185e	2026-05-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 218755 application number: ANDA218755
Paliperidone	PALIPERIDONE	Bryant Ranch Prepack	f0c13f91-0232-48b0-aa13-121805b8da13	2026-05-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 218755 application number: ANDA218755
Paliperidone	PALIPERIDONE	Bryant Ranch Prepack	c7472b50-fa6c-4127-a4b3-3645436274ee	2026-05-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 218755 application number: ANDA218755 ndc (product): 72162-2649
Paliperidone	PALIPERIDONE	Westminster Pharmaceuticals, LLC	1745a460-5e3a-4a1f-8eb3-64bb112f47a4	2026-04-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 218755 application number: ANDA218755
PALIPERIDONE	PALIPERIDONE	Eskayef Pharmaceuticals Limited	de95e29f-a030-4777-a601-874500ab8e91	2025-09-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 218755 application number: ANDA218755

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
672567	paliperidone 3 MG 24HR Extended Release Oral Tablet	PSN	c7472b50-fa6c-4127-a4b3-3645436274ee	100
672567	24 HR paliperidone 3 MG Extended Release Oral Tablet	SCD	c7472b50-fa6c-4127-a4b3-3645436274ee	100
672567	paliperidone 3 MG 24 HR Extended Release Oral Tablet	SY	c7472b50-fa6c-4127-a4b3-3645436274ee	100

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
72162-2649-3	72162264903	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (72162-2649-3)	2026-05-27	No	No	Current