Paliperidone

Product NDC: 72819-159
Requested package NDC: 72819-159-03
11-digit product format: 728190159
Labeler code: 72819
Product ID: 72819-159_4745a6d1-d9f5-2ff9-e063-6394a90a2825
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: paliperidone
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: Archis Pharma LLC
Application: ANDA203802
Marketing category: ANDA
Marketing start: 2022-04-27
Substance: PALIPERIDONE
Active strength: 6 mg/1
Pharmacologic classes: Atypical Antipsychotic [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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 · 176 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
2026-10-15 13:18:30	2026-09	A203802-001	PALIPERIDONE	1.5MG	TABLET, EXTENDED RELEASE / ORAL		2015-09-24	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A203802-002	PALIPERIDONE	3MG	TABLET, EXTENDED RELEASE / ORAL		2015-09-24	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A203802-003	PALIPERIDONE	6MG	TABLET, EXTENDED RELEASE / ORAL		2015-09-24	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A203802-004	PALIPERIDONE	9MG	TABLET, EXTENDED RELEASE / ORAL		2015-09-24	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A203802-001	PALIPERIDONE	1.5MG	TABLET, EXTENDED RELEASE / ORAL		2015-09-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203802-002	PALIPERIDONE	3MG	TABLET, EXTENDED RELEASE / ORAL		2015-09-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203802-003	PALIPERIDONE	6MG	TABLET, EXTENDED RELEASE / ORAL		2015-09-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203802-004	PALIPERIDONE	9MG	TABLET, EXTENDED RELEASE / ORAL		2015-09-24	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A203802-001	PALIPERIDONE	1.5MG	TABLET, EXTENDED RELEASE / ORAL		2015-09-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203802-002	PALIPERIDONE	3MG	TABLET, EXTENDED RELEASE / ORAL		2015-09-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203802-003	PALIPERIDONE	6MG	TABLET, EXTENDED RELEASE / ORAL		2015-09-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203802-004	PALIPERIDONE	9MG	TABLET, EXTENDED RELEASE / ORAL		2015-09-24	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 4 · 156 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203802-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203802-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203802-003	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203802-004	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203802-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203802-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203802-003	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203802-004	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203802-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203802-002	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203802-003	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203802-004	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203802-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203802-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203802-003	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203802-004	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203802-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203802-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203802-003	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203802-004	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203802-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203802-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203802-003	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203802-004	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203802-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203802-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203802-003	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203802-004	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203802-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A203802-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A203802-003	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A203802-004	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203802-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A203802-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A203802-003	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A203802-004	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203802-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203802-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203802-003	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203802-004	AB	1	`87673890dc5c…`

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: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PALIPERIDONE	6 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 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
672567	Internal RxNorm lookup
672569	Internal RxNorm lookup
672571	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
e713556e-028e-0f4c-e053-2995a90a9e9f	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	Strength	SPL version
72819-159-03	Paliperidone	30 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED, EXTENDED RE	30		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72819-159-03	EA - Each	72819-159	a1465f0d-3ebe-4ff3-862f-b4ad1784bd8f	1	2023-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72819-159	PALIPERIDONE TABLET, FILM COATED, EXTENDED RELEASE [ARCHIS PHARMA LLC]	2	Current NDC, Legacy NDC, 1 package rows	20230929_e713556e-028e-0f4c-e053-2995a90a9e9f.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
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 ndc (package): 72819-159-03 ndc (product): 72819-159 ndc11 (package): 72819015903

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	e713556e-028e-0f4c-e053-2995a90a9e9f	5
672569	paliperidone 6 MG 24HR Extended Release Oral Tablet	PSN	e713556e-028e-0f4c-e053-2995a90a9e9f	5
672571	paliperidone 9 MG 24HR Extended Release Oral Tablet	PSN	e713556e-028e-0f4c-e053-2995a90a9e9f	5
672567	24 HR paliperidone 3 MG Extended Release Oral Tablet	SCD	e713556e-028e-0f4c-e053-2995a90a9e9f	5
672569	24 HR paliperidone 6 MG Extended Release Oral Tablet	SCD	e713556e-028e-0f4c-e053-2995a90a9e9f	5
672571	24 HR paliperidone 9 MG Extended Release Oral Tablet	SCD	e713556e-028e-0f4c-e053-2995a90a9e9f	5
672567	paliperidone 3 MG 24 HR Extended Release Oral Tablet	SY	e713556e-028e-0f4c-e053-2995a90a9e9f	5
672569	paliperidone 6 MG 24 HR Extended Release Oral Tablet	SY	e713556e-028e-0f4c-e053-2995a90a9e9f	5
672571	paliperidone 9 MG 24 HR Extended Release Oral Tablet	SY	e713556e-028e-0f4c-e053-2995a90a9e9f	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
72819-159-03	72819015903	30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (72819-159-03)	2022-04-27	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Paliperidone	Archis Pharma LLC \| RK Pharma Inc. \| mylan Laboratories Limited	2025-12-31	HUMAN PRESCRIPTION DRUG LABEL	5
Paliperidone	REMEDYREPACK INC.	2024-04-02	HUMAN PRESCRIPTION DRUG LABEL	3