Paliperidone

Product NDC: 27808-222
Requested package NDC: 27808-222-01
11-digit product format: 278080222
Labeler code: 27808
Product ID: 27808-222_ffd2bfbd-11f5-436a-9ebf-bbd4ef92bacd
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: paliperidone
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Tris Pharma Inc
Application: ANDA212807
Marketing category: ANDA
Marketing start: 2020-10-29
Substance: PALIPERIDONE
Active strength: 1.5 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 1.

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
A212807-001	PALIPERIDONE	PALIPERIDONE	1.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-29
A212807-002	PALIPERIDONE	PALIPERIDONE	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-29
A212807-003	PALIPERIDONE	PALIPERIDONE	6MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-29
A212807-004	PALIPERIDONE	PALIPERIDONE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A212807-001	AB
A212807-002	AB
A212807-003	AB
A212807-004	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 · 144 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
2026-02-19 14:30 UTC	2026-02	A212807-001	PALIPERIDONE	1.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212807-002	PALIPERIDONE	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212807-003	PALIPERIDONE	6MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212807-004	PALIPERIDONE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212807-001	PALIPERIDONE	1.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212807-002	PALIPERIDONE	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212807-003	PALIPERIDONE	6MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212807-004	PALIPERIDONE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212807-001	PALIPERIDONE	1.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212807-002	PALIPERIDONE	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212807-003	PALIPERIDONE	6MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212807-004	PALIPERIDONE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212807-001	PALIPERIDONE	1.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212807-002	PALIPERIDONE	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212807-003	PALIPERIDONE	6MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212807-004	PALIPERIDONE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212807-001	PALIPERIDONE	1.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212807-002	PALIPERIDONE	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212807-003	PALIPERIDONE	6MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212807-004	PALIPERIDONE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212807-001	PALIPERIDONE	1.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212807-002	PALIPERIDONE	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212807-003	PALIPERIDONE	6MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212807-004	PALIPERIDONE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212807-001	PALIPERIDONE	1.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212807-002	PALIPERIDONE	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212807-003	PALIPERIDONE	6MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212807-004	PALIPERIDONE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212807-001	PALIPERIDONE	1.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212807-002	PALIPERIDONE	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212807-003	PALIPERIDONE	6MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212807-004	PALIPERIDONE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212807-001	PALIPERIDONE	1.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212807-002	PALIPERIDONE	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212807-003	PALIPERIDONE	6MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212807-004	PALIPERIDONE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212807-001	PALIPERIDONE	1.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212807-002	PALIPERIDONE	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212807-003	PALIPERIDONE	6MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212807-004	PALIPERIDONE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-29	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 144 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A212807-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212807-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212807-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212807-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212807-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212807-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212807-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212807-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212807-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212807-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212807-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212807-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212807-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212807-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212807-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212807-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212807-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212807-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212807-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212807-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212807-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212807-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212807-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212807-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212807-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212807-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212807-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212807-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212807-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212807-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212807-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212807-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212807-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212807-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212807-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212807-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212807-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212807-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212807-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212807-004	AB	1	`d06236e962d9…`

Additional Listing Data#

Finished product: Yes
Brand name base: Paliperidone
Listing expiration: 2026-12-31

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
d7033e52-3df2-48e2-adda-15a57c2f148f	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
27808-222-01	Paliperidone	30 in 1 BOTTLE	TABLET, EXTENDED RELEASE	30		7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
27808-222-01	EA - Each	27808-222	c6196ab8-8345-4597-8938-fab74c3bf982	1	2022-02-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
27808-222	PALIPERIDONE TABLET, EXTENDED RELEASE [TRIS PHARMA INC]	7	Current NDC, Legacy NDC, 1 package rows	20241116_d7033e52-3df2-48e2-adda-15a57c2f148f.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	Tris Pharma Inc	d7033e52-3df2-48e2-adda-15a57c2f148f	2024-07-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212807 application number: ANDA212807 ndc (package): 27808-222-01 ndc (product): 27808-222 ndc11 (package): 27808022201

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	d7033e52-3df2-48e2-adda-15a57c2f148f	7
672567	paliperidone 3 MG 24HR Extended Release Oral Tablet	PSN	d7033e52-3df2-48e2-adda-15a57c2f148f	7
672569	paliperidone 6 MG 24HR Extended Release Oral Tablet	PSN	d7033e52-3df2-48e2-adda-15a57c2f148f	7
672571	paliperidone 9 MG 24HR Extended Release Oral Tablet	PSN	d7033e52-3df2-48e2-adda-15a57c2f148f	7
866103	24 HR paliperidone 1.5 MG Extended Release Oral Tablet	SCD	d7033e52-3df2-48e2-adda-15a57c2f148f	7
672567	24 HR paliperidone 3 MG Extended Release Oral Tablet	SCD	d7033e52-3df2-48e2-adda-15a57c2f148f	7
672569	24 HR paliperidone 6 MG Extended Release Oral Tablet	SCD	d7033e52-3df2-48e2-adda-15a57c2f148f	7
672571	24 HR paliperidone 9 MG Extended Release Oral Tablet	SCD	d7033e52-3df2-48e2-adda-15a57c2f148f	7
866103	paliperidone 1.5 MG 24 HR Extended Release Oral Tablet	SY	d7033e52-3df2-48e2-adda-15a57c2f148f	7
672567	paliperidone 3 MG 24 HR Extended Release Oral Tablet	SY	d7033e52-3df2-48e2-adda-15a57c2f148f	7
672569	paliperidone 6 MG 24 HR Extended Release Oral Tablet	SY	d7033e52-3df2-48e2-adda-15a57c2f148f	7
672571	paliperidone 9 MG 24 HR Extended Release Oral Tablet	SY	d7033e52-3df2-48e2-adda-15a57c2f148f	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
27808-222-01	27808022201	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (27808-222-01)	2021-10-25	0000-00-00	No	No	Current