Paliperidone

Product NDC: 67046-1630
11-digit product format: 670461630
Labeler code: 67046
Product ID: 67046-1630_463dba10-7245-c1aa-e063-6394a90ad7b1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Paliperidone
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Coupler LLC
Application: ANDA204707
Marketing category: ANDA
Marketing start: 2025-12-18
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 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
A204707-001	PALIPERIDONE	PALIPERIDONE	1.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-09-23
A204707-002	PALIPERIDONE	PALIPERIDONE	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-09-23
A204707-003	PALIPERIDONE	PALIPERIDONE	6MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-09-23
A204707-004	PALIPERIDONE	PALIPERIDONE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-09-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A204707-001	AB
A204707-002	AB
A204707-003	AB
A204707-004	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 4 · 160 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	A204707-001	PALIPERIDONE	1.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-09-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204707-002	PALIPERIDONE	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-09-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204707-003	PALIPERIDONE	6MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-09-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204707-004	PALIPERIDONE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-09-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204707-001	PALIPERIDONE	1.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-09-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204707-002	PALIPERIDONE	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-09-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204707-003	PALIPERIDONE	6MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-09-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204707-004	PALIPERIDONE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-09-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204707-001	PALIPERIDONE	1.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-09-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204707-002	PALIPERIDONE	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-09-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204707-003	PALIPERIDONE	6MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-09-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204707-004	PALIPERIDONE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-09-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204707-001	PALIPERIDONE	1.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-09-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204707-002	PALIPERIDONE	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-09-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204707-003	PALIPERIDONE	6MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-09-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204707-004	PALIPERIDONE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-09-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204707-001	PALIPERIDONE	1.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-09-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204707-002	PALIPERIDONE	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-09-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204707-003	PALIPERIDONE	6MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-09-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204707-004	PALIPERIDONE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-09-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204707-001	PALIPERIDONE	1.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-09-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204707-002	PALIPERIDONE	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-09-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204707-003	PALIPERIDONE	6MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-09-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204707-004	PALIPERIDONE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-09-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204707-001	PALIPERIDONE	1.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-09-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204707-002	PALIPERIDONE	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-09-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204707-003	PALIPERIDONE	6MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-09-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204707-004	PALIPERIDONE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-09-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204707-001	PALIPERIDONE	1.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-09-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204707-002	PALIPERIDONE	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-09-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204707-003	PALIPERIDONE	6MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-09-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204707-004	PALIPERIDONE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-09-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204707-001	PALIPERIDONE	1.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-09-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204707-002	PALIPERIDONE	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-09-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204707-003	PALIPERIDONE	6MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-09-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204707-004	PALIPERIDONE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-09-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204707-001	PALIPERIDONE	1.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-09-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204707-002	PALIPERIDONE	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-09-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204707-003	PALIPERIDONE	6MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-09-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204707-004	PALIPERIDONE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-09-23	`d8e5a09893c0…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 160 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	A204707-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204707-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204707-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204707-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204707-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204707-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204707-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204707-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204707-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204707-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204707-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204707-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204707-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204707-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204707-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204707-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204707-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204707-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204707-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204707-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204707-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204707-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204707-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204707-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204707-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204707-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204707-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204707-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204707-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204707-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204707-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204707-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204707-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204707-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204707-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204707-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204707-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204707-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204707-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204707-004	AB	1	`d8e5a09893c0…`

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
672569	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
463db841-297f-7692-e063-6394a90a8c14	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
67046-1630-3	Paliperidone	30 in 1 BLISTER PACK	TABLET, EXTENDED RELEASE	30		1

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Paliperidone	PALIPERIDONE	AvKARE	018cf3ca-bee9-23a6-e063-6394a90ad905	2026-01-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204707 application number: ANDA204707
Paliperidone	PALIPERIDONE	Coupler LLC	463db841-297f-7692-e063-6394a90a8c14	2025-12-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204707 application number: ANDA204707 ndc (product): 67046-1630
Paliperidone	PALIPERIDONE	Amneal Pharmaceuticals LLC	7b269778-803b-4ce2-a8c0-636fb131d16a	2025-09-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204707 application number: ANDA204707
Paliperidone	PALIPERIDONE	Coupler LLC	313538c9-01d3-1558-e063-6394a90aa21d	2025-03-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204707 application number: ANDA204707

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
672569	paliperidone 6 MG 24HR Extended Release Oral Tablet	PSN	463db841-297f-7692-e063-6394a90a8c14	1
672569	24 HR paliperidone 6 MG Extended Release Oral Tablet	SCD	463db841-297f-7692-e063-6394a90a8c14	1
672569	paliperidone 6 MG 24 HR Extended Release Oral Tablet	SY	463db841-297f-7692-e063-6394a90a8c14	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
67046-1630-3	67046163003	30 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (67046-1630-3)	2025-12-18	No	No	Current