PALIPERIDONE

Product NDC: 43975-350
Requested package NDC: 43975-350-03
11-digit product format: 439750350
Labeler code: 43975
Product ID: 43975-350_338098af-3cc9-1639-e063-6394a90a6550
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: PALIPERIDONE
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: ANI Pharmaceuticals, Inc.
Application: ANDA204452
Marketing category: ANDA
Marketing start: 2019-11-27
Substance: PALIPERIDONE
Active strength: 3 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
A204452-001	PALIPERIDONE	PALIPERIDONE	1.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-06-12
A204452-002	PALIPERIDONE	PALIPERIDONE	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-06-12
A204452-003	PALIPERIDONE	PALIPERIDONE	6MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-06-12
A204452-004	PALIPERIDONE	PALIPERIDONE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-06-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A204452-001	AB
A204452-002	AB
A204452-003	AB
A204452-004	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 · 164 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	A204452-001	PALIPERIDONE	1.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-06-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204452-002	PALIPERIDONE	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-06-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204452-003	PALIPERIDONE	6MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-06-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204452-004	PALIPERIDONE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-06-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204452-001	PALIPERIDONE	1.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-06-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204452-002	PALIPERIDONE	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-06-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204452-003	PALIPERIDONE	6MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-06-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204452-004	PALIPERIDONE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-06-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204452-001	PALIPERIDONE	1.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-06-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204452-002	PALIPERIDONE	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-06-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204452-003	PALIPERIDONE	6MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-06-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204452-004	PALIPERIDONE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-06-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204452-001	PALIPERIDONE	1.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-06-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204452-002	PALIPERIDONE	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-06-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204452-003	PALIPERIDONE	6MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-06-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204452-004	PALIPERIDONE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-06-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204452-001	PALIPERIDONE	1.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-06-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204452-002	PALIPERIDONE	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-06-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204452-003	PALIPERIDONE	6MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-06-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204452-004	PALIPERIDONE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-06-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204452-001	PALIPERIDONE	1.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-06-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204452-002	PALIPERIDONE	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-06-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204452-003	PALIPERIDONE	6MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-06-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204452-004	PALIPERIDONE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-06-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204452-001	PALIPERIDONE	1.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-06-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204452-002	PALIPERIDONE	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-06-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204452-003	PALIPERIDONE	6MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-06-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204452-004	PALIPERIDONE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-06-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204452-001	PALIPERIDONE	1.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-06-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204452-002	PALIPERIDONE	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-06-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204452-003	PALIPERIDONE	6MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-06-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204452-004	PALIPERIDONE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-06-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204452-001	PALIPERIDONE	1.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-06-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204452-002	PALIPERIDONE	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-06-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204452-003	PALIPERIDONE	6MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-06-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204452-004	PALIPERIDONE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-06-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204452-001	PALIPERIDONE	1.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-06-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204452-002	PALIPERIDONE	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-06-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204452-003	PALIPERIDONE	6MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-06-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204452-004	PALIPERIDONE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-06-12	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 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	A204452-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204452-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204452-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204452-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204452-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204452-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204452-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204452-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204452-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204452-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204452-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204452-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204452-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204452-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204452-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204452-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204452-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204452-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204452-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204452-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204452-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204452-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204452-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204452-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204452-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204452-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204452-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204452-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204452-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204452-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204452-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204452-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204452-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204452-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204452-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204452-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204452-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204452-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204452-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204452-004	AB	1	`d06236e962d9…`

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 SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
bbbaa057-f587-4eb9-a0d2-463dbcd57661	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
43975-350-03	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
43975-350-03	EA - Each	43975-350	5c3c747c-4712-42d0-bf07-569c95552352	1	2020-01-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43975-350	PALIPERIDONE TABLET, EXTENDED RELEASE [ANI PHARMACEUTICALS, INC.]	7	Current NDC, Legacy NDC, 1 package rows	20250426_bbbaa057-f587-4eb9-a0d2-463dbcd57661.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	ANI Pharmaceuticals, Inc.	bbbaa057-f587-4eb9-a0d2-463dbcd57661	2026-07-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204452 application number: ANDA204452 ndc (package): 43975-350-03 ndc (product): 43975-350 ndc11 (package): 43975035003

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	bbbaa057-f587-4eb9-a0d2-463dbcd57661	7
672567	paliperidone 3 MG 24HR Extended Release Oral Tablet	PSN	bbbaa057-f587-4eb9-a0d2-463dbcd57661	7
672569	paliperidone 6 MG 24HR Extended Release Oral Tablet	PSN	bbbaa057-f587-4eb9-a0d2-463dbcd57661	7
672571	paliperidone 9 MG 24HR Extended Release Oral Tablet	PSN	bbbaa057-f587-4eb9-a0d2-463dbcd57661	7
866103	24 HR paliperidone 1.5 MG Extended Release Oral Tablet	SCD	bbbaa057-f587-4eb9-a0d2-463dbcd57661	7
672567	24 HR paliperidone 3 MG Extended Release Oral Tablet	SCD	bbbaa057-f587-4eb9-a0d2-463dbcd57661	7
672569	24 HR paliperidone 6 MG Extended Release Oral Tablet	SCD	bbbaa057-f587-4eb9-a0d2-463dbcd57661	7
672571	24 HR paliperidone 9 MG Extended Release Oral Tablet	SCD	bbbaa057-f587-4eb9-a0d2-463dbcd57661	7
866103	paliperidone 1.5 MG 24 HR Extended Release Oral Tablet	SY	bbbaa057-f587-4eb9-a0d2-463dbcd57661	7
672567	paliperidone 3 MG 24 HR Extended Release Oral Tablet	SY	bbbaa057-f587-4eb9-a0d2-463dbcd57661	7
672569	paliperidone 6 MG 24 HR Extended Release Oral Tablet	SY	bbbaa057-f587-4eb9-a0d2-463dbcd57661	7
672571	paliperidone 9 MG 24 HR Extended Release Oral Tablet	SY	bbbaa057-f587-4eb9-a0d2-463dbcd57661	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
43975-350-03	43975035003	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (43975-350-03)	2019-11-27	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PALIPERIDONE	ANI Pharmaceuticals, Inc. \| Inventia Healthcare Limited	2026-07-28	HUMAN PRESCRIPTION DRUG LABEL	8