Paliperidone

Product NDC: 0904-6935
11-digit product format: 009046935
Labeler code: 0904
Product ID: 0904-6935_30f0d212-ed22-4d6e-9270-53a94f1d119c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Paliperidone
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: Major Pharmaceuticals
Application: ANDA205618
Marketing category: ANDA
Marketing start: 2018-08-01
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 42.

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
A205618-001	PALIPERIDONE	PALIPERIDONE	1.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-04-06
A205618-002	PALIPERIDONE	PALIPERIDONE	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-04-06
A205618-003	PALIPERIDONE	PALIPERIDONE	6MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-04-06
A205618-004	PALIPERIDONE	PALIPERIDONE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-04-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A205618-001	AB
A205618-002	AB
A205618-003	AB
A205618-004	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.

Product history page 1 of 5 · 168 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
2026-08-18 06:07:40	2026-07	A205618-001	PALIPERIDONE	1.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-04-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205618-002	PALIPERIDONE	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-04-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205618-003	PALIPERIDONE	6MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-04-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205618-004	PALIPERIDONE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-04-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205618-001	PALIPERIDONE	1.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-04-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205618-002	PALIPERIDONE	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-04-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205618-003	PALIPERIDONE	6MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-04-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205618-004	PALIPERIDONE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-04-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205618-001	PALIPERIDONE	1.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-04-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205618-002	PALIPERIDONE	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-04-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205618-003	PALIPERIDONE	6MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-04-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205618-004	PALIPERIDONE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-04-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205618-001	PALIPERIDONE	1.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-04-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205618-002	PALIPERIDONE	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-04-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205618-003	PALIPERIDONE	6MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-04-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205618-004	PALIPERIDONE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-04-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205618-001	PALIPERIDONE	1.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-04-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205618-002	PALIPERIDONE	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-04-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205618-003	PALIPERIDONE	6MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-04-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205618-004	PALIPERIDONE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-04-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205618-001	PALIPERIDONE	1.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-04-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205618-002	PALIPERIDONE	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-04-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205618-003	PALIPERIDONE	6MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-04-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205618-004	PALIPERIDONE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-04-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205618-001	PALIPERIDONE	1.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-04-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205618-002	PALIPERIDONE	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-04-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205618-003	PALIPERIDONE	6MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-04-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205618-004	PALIPERIDONE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-04-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205618-001	PALIPERIDONE	1.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-04-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205618-002	PALIPERIDONE	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-04-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205618-003	PALIPERIDONE	6MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-04-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205618-004	PALIPERIDONE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-04-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205618-001	PALIPERIDONE	1.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-04-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205618-002	PALIPERIDONE	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-04-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205618-003	PALIPERIDONE	6MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-04-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205618-004	PALIPERIDONE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-04-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205618-001	PALIPERIDONE	1.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-04-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205618-002	PALIPERIDONE	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-04-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205618-003	PALIPERIDONE	6MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-04-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205618-004	PALIPERIDONE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-04-06	`d8e5a09893c0…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 168 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	A205618-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205618-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205618-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205618-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205618-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205618-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205618-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205618-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205618-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205618-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205618-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205618-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205618-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205618-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205618-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205618-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205618-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205618-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205618-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205618-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205618-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205618-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205618-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205618-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205618-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205618-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205618-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205618-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205618-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205618-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205618-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205618-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205618-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205618-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205618-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205618-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205618-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205618-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205618-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205618-004	AB	1	`d8e5a09893c0…`

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 · 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
528a962a-4924-4c48-93ce-6ab1f019e52c	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
0904-6935-61	Paliperidone	100 in 1 CARTON	TABLET, FILM COATED, EXTENDED RE	100		8
0904-6935-61	Paliperidone	1 in 1 BLISTER PACK	TABLET, FILM COATED, EXTENDED RE	1		8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0904-6935-61	EA - Each	0904-6935	aea1e653-fdfe-437f-bd30-34b4170952b5	1	2020-01-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0904-6935	PALIPERIDONE TABLET, EXTENDED RELEASE [MAJOR PHARMACEUTICALS]	6	Current NDC, Legacy NDC, 2 package rows	20250510_528a962a-4924-4c48-93ce-6ab1f019e52c.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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Paliperidone	PALIPERIDONE	Major Pharmaceuticals	528a962a-4924-4c48-93ce-6ab1f019e52c	2026-04-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205618 application number: ANDA205618 ndc (product): 0904-6935
Paliperidone	PALIPERIDONE	Sun Pharmaceutical Industries, Inc.	0dc3a9b2-2edf-4fa2-a949-459b4218e763	2026-04-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205618 application number: ANDA205618
Paliperidone	PALIPERIDONE	NorthStar RxLLC	5589ec69-c49c-44a7-9561-bbffeb918d1f	2026-04-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205618 application number: ANDA205618
Paliperidone	PALIPERIDONE	American Health Packaging	c6d80cc0-596e-49b9-8216-34e7b01e2df2	2025-10-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205618 application number: ANDA205618
Paliperidone	PALIPERIDONE	REMEDYREPACK INC.	a5492459-e0a2-4c16-9fff-c886e0b4c700	2025-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205618 application number: ANDA205618
Paliperidone	PALIPERIDONE	REMEDYREPACK INC.	85cdf6fb-d59f-4231-bd21-c8435df5930d	2025-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205618 application number: ANDA205618
Paliperidone	PALIPERIDONE	REMEDYREPACK INC.	f13d3678-a861-42ba-be44-0d89f1b66ef3	2025-09-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205618 application number: ANDA205618

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	528a962a-4924-4c48-93ce-6ab1f019e52c	8
672569	paliperidone 6 MG 24HR Extended Release Oral Tablet	PSN	528a962a-4924-4c48-93ce-6ab1f019e52c	8
672571	paliperidone 9 MG 24HR Extended Release Oral Tablet	PSN	528a962a-4924-4c48-93ce-6ab1f019e52c	8
672567	24 HR paliperidone 3 MG Extended Release Oral Tablet	SCD	528a962a-4924-4c48-93ce-6ab1f019e52c	8
672569	24 HR paliperidone 6 MG Extended Release Oral Tablet	SCD	528a962a-4924-4c48-93ce-6ab1f019e52c	8
672571	24 HR paliperidone 9 MG Extended Release Oral Tablet	SCD	528a962a-4924-4c48-93ce-6ab1f019e52c	8
672567	paliperidone 3 MG 24 HR Extended Release Oral Tablet	SY	528a962a-4924-4c48-93ce-6ab1f019e52c	8
672569	paliperidone 6 MG 24 HR Extended Release Oral Tablet	SY	528a962a-4924-4c48-93ce-6ab1f019e52c	8
672571	paliperidone 9 MG 24 HR Extended Release Oral Tablet	SY	528a962a-4924-4c48-93ce-6ab1f019e52c	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0904-6935-61	00904693561	100 BLISTER PACK in 1 CARTON (0904-6935-61) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK	100 blister pack	2018-08-01	0000-00-00	No	No	Current