PALIPERIDONE

Product NDC: 31722-317
11-digit product format: 317220317
Labeler code: 31722
Product ID: 31722-317_a6b46674-2b24-4485-9d9f-7f4bcfb20ae3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: paliperidone
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Camber Pharmaceuticals, Inc
Application: ANDA216174
Marketing category: ANDA
Marketing start: 2023-08-23
Substance: PALIPERIDONE
Active strength: 1.5 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
A216174-001	PALIPERIDONE	PALIPERIDONE	1.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-08-23
A216174-002	PALIPERIDONE	PALIPERIDONE	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-08-23
A216174-003	PALIPERIDONE	PALIPERIDONE	6MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-08-23
A216174-004	PALIPERIDONE	PALIPERIDONE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-08-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A216174-001	AB
A216174-002	AB
A216174-003	AB
A216174-004	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 3 · 84 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	A216174-001	PALIPERIDONE	1.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-08-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A216174-002	PALIPERIDONE	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-08-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A216174-003	PALIPERIDONE	6MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-08-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A216174-004	PALIPERIDONE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-08-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A216174-001	PALIPERIDONE	1.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-08-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216174-002	PALIPERIDONE	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-08-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216174-003	PALIPERIDONE	6MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-08-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216174-004	PALIPERIDONE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-08-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216174-001	PALIPERIDONE	1.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-08-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216174-002	PALIPERIDONE	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-08-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216174-003	PALIPERIDONE	6MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-08-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216174-004	PALIPERIDONE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-08-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216174-001	PALIPERIDONE	1.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-08-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216174-002	PALIPERIDONE	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-08-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216174-003	PALIPERIDONE	6MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-08-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216174-004	PALIPERIDONE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-08-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216174-001	PALIPERIDONE	1.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-08-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216174-002	PALIPERIDONE	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-08-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216174-003	PALIPERIDONE	6MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-08-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216174-004	PALIPERIDONE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-08-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216174-001	PALIPERIDONE	1.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-08-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216174-002	PALIPERIDONE	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-08-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216174-003	PALIPERIDONE	6MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-08-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216174-004	PALIPERIDONE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-08-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216174-001	PALIPERIDONE	1.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-08-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216174-002	PALIPERIDONE	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-08-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216174-003	PALIPERIDONE	6MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-08-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216174-004	PALIPERIDONE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-08-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216174-001	PALIPERIDONE	1.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-08-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216174-002	PALIPERIDONE	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-08-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216174-003	PALIPERIDONE	6MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-08-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216174-004	PALIPERIDONE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-08-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216174-001	PALIPERIDONE	1.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-08-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216174-002	PALIPERIDONE	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-08-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216174-003	PALIPERIDONE	6MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-08-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216174-004	PALIPERIDONE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-08-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216174-001	PALIPERIDONE	1.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-08-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216174-002	PALIPERIDONE	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-08-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216174-003	PALIPERIDONE	6MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-08-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216174-004	PALIPERIDONE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-08-23	`d8e5a09893c0…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 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	A216174-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A216174-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A216174-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A216174-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A216174-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216174-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216174-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216174-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216174-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216174-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216174-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216174-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216174-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216174-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216174-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216174-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216174-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216174-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216174-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216174-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216174-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216174-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216174-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216174-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216174-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216174-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216174-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216174-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216174-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216174-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216174-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216174-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216174-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216174-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216174-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216174-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216174-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216174-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216174-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216174-004	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	1.5 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 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
672567	Internal RxNorm lookup
672569	Internal RxNorm lookup
672571	Internal RxNorm lookup
866103	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
1cfcad42-da71-457d-b1e1-aee806642d0c	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
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
fd328049-536a-4914-b42e-93bf4d93db24	Product name	1	20220307
0f0756fc-4d63-4f75-afcc-9c5e62a38d69	Product name	2	20220304
f1e0dc7e-7d61-4625-b6d9-4894927679d7	Product name	2	20211025
e4870509-7e28-6f92-f0be-dd3dd889a9cf	Product name	5	20200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cd	Product name	2	20190619
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
5668b646-cd56-c3c7-bdea-3f6b1a8840db	Product name	1	20140508
684ea482-2e8b-14af-5664-b98f1e402036	Product name	1	20140508
810ab97e-f109-f41c-7c83-6a652a9cbf43	Product name	1	20140508
87711080-88eb-65c5-b2dd-bf99e700a372	Product name	1	20140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2dd	Product name	1	20140508
b060cc1a-fe47-856b-0b77-4448b5963de8	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
31722-317-30	PALIPERIDONE	30 in 1 BOTTLE	TABLET, EXTENDED RELEASE	30		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
31722-317-30	EA - Each	31722-317	9ad87f8e-a276-456e-b40b-2baef6306a9d	1	2024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
31722-317	PALIPERIDONE TABLET, EXTENDED RELEASE [CAMBER PHARMACEUTICALS, INC]	1	Current NDC, 1 package rows	20240328_1cfcad42-da71-457d-b1e1-aee806642d0c.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	Camber Pharmaceuticals, Inc	1cfcad42-da71-457d-b1e1-aee806642d0c	2026-04-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216174 application number: ANDA216174 ndc (product): 31722-317

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
866103	paliperidone 1.5 MG 24HR Extended Release Oral Tablet	PSN	1cfcad42-da71-457d-b1e1-aee806642d0c	2
672567	paliperidone 3 MG 24HR Extended Release Oral Tablet	PSN	1cfcad42-da71-457d-b1e1-aee806642d0c	2
672569	paliperidone 6 MG 24HR Extended Release Oral Tablet	PSN	1cfcad42-da71-457d-b1e1-aee806642d0c	2
672571	paliperidone 9 MG 24HR Extended Release Oral Tablet	PSN	1cfcad42-da71-457d-b1e1-aee806642d0c	2
866103	24 HR paliperidone 1.5 MG Extended Release Oral Tablet	SCD	1cfcad42-da71-457d-b1e1-aee806642d0c	2
672567	24 HR paliperidone 3 MG Extended Release Oral Tablet	SCD	1cfcad42-da71-457d-b1e1-aee806642d0c	2
672569	24 HR paliperidone 6 MG Extended Release Oral Tablet	SCD	1cfcad42-da71-457d-b1e1-aee806642d0c	2
672571	24 HR paliperidone 9 MG Extended Release Oral Tablet	SCD	1cfcad42-da71-457d-b1e1-aee806642d0c	2
866103	paliperidone 1.5 MG 24 HR Extended Release Oral Tablet	SY	1cfcad42-da71-457d-b1e1-aee806642d0c	2
672567	paliperidone 3 MG 24 HR Extended Release Oral Tablet	SY	1cfcad42-da71-457d-b1e1-aee806642d0c	2
672569	paliperidone 6 MG 24 HR Extended Release Oral Tablet	SY	1cfcad42-da71-457d-b1e1-aee806642d0c	2
672571	paliperidone 9 MG 24 HR Extended Release Oral Tablet	SY	1cfcad42-da71-457d-b1e1-aee806642d0c	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
31722-317-30	31722031730	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (31722-317-30)	2023-08-23	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PALIPERIDONE	Camber Pharmaceuticals, Inc \| Ascent Pharmaceuticals, Inc.	2026-04-23	HUMAN PRESCRIPTION DRUG LABEL	2