paliperidone

Product NDC: 46708-803
11-digit product format: 467080803
Labeler code: 46708
Product ID: 46708-803_be30f3cc-55fb-4a74-9778-60573a7f18c6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: paliperidone
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Alembic Pharmaceuticals Limited
Application: ANDA218330
Marketing category: ANDA
Marketing start: 2024-09-30
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 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
A218330-001	PALIPERIDONE	PALIPERIDONE	1.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-09-26
A218330-002	PALIPERIDONE	PALIPERIDONE	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-09-26
A218330-003	PALIPERIDONE	PALIPERIDONE	6MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-09-26
A218330-004	PALIPERIDONE	PALIPERIDONE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-09-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A218330-001	AB
A218330-002	AB
A218330-003	AB
A218330-004	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 2 · 44 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	A218330-001	PALIPERIDONE	1.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-09-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A218330-002	PALIPERIDONE	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-09-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A218330-003	PALIPERIDONE	6MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-09-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A218330-004	PALIPERIDONE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-09-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A218330-001	PALIPERIDONE	1.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-09-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218330-002	PALIPERIDONE	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-09-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218330-003	PALIPERIDONE	6MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-09-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218330-004	PALIPERIDONE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-09-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218330-001	PALIPERIDONE	1.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-09-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218330-002	PALIPERIDONE	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-09-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218330-003	PALIPERIDONE	6MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-09-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218330-004	PALIPERIDONE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-09-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A218330-001	PALIPERIDONE	1.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-09-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A218330-002	PALIPERIDONE	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-09-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A218330-003	PALIPERIDONE	6MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-09-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A218330-004	PALIPERIDONE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-09-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218330-001	PALIPERIDONE	1.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-09-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218330-002	PALIPERIDONE	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-09-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218330-003	PALIPERIDONE	6MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-09-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218330-004	PALIPERIDONE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-09-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218330-001	PALIPERIDONE	1.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-09-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218330-002	PALIPERIDONE	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-09-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218330-003	PALIPERIDONE	6MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-09-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218330-004	PALIPERIDONE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-09-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A218330-001	PALIPERIDONE	1.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-09-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A218330-002	PALIPERIDONE	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-09-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A218330-003	PALIPERIDONE	6MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-09-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A218330-004	PALIPERIDONE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-09-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A218330-001	PALIPERIDONE	1.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-09-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A218330-002	PALIPERIDONE	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-09-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A218330-003	PALIPERIDONE	6MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-09-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A218330-004	PALIPERIDONE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-09-26	`2680178bc6a6…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A218330-001	PALIPERIDONE	1.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-09-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A218330-002	PALIPERIDONE	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-09-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A218330-003	PALIPERIDONE	6MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-09-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A218330-004	PALIPERIDONE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-09-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A218330-001	PALIPERIDONE	1.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-09-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A218330-002	PALIPERIDONE	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-09-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A218330-003	PALIPERIDONE	6MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-09-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A218330-004	PALIPERIDONE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-09-26	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 44 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	A218330-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A218330-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A218330-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A218330-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A218330-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218330-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218330-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218330-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218330-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218330-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218330-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218330-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A218330-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A218330-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A218330-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A218330-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218330-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218330-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218330-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218330-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218330-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218330-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218330-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218330-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A218330-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A218330-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A218330-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A218330-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A218330-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A218330-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A218330-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A218330-004	AB	1	`2680178bc6a6…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A218330-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A218330-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A218330-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A218330-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A218330-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A218330-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A218330-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A218330-004	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
be30f3cc-55fb-4a74-9778-60573a7f18c6	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
46708-803-30	paliperidone	30 in 1 BOTTLE	TABLET, EXTENDED RELEASE	30		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
46708-803	PALIPERIDONE TABLET, EXTENDED RELEASE [ALEMBIC PHARMACEUTICALS LIMITED]	1	Current NDC, 1 package rows	20241004_be30f3cc-55fb-4a74-9778-60573a7f18c6.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
paliperidone	PALIPERIDONE	Alembic Pharmaceuticals Inc.	45fc28d1-132f-413b-a407-dc90e1229ee2	2025-02-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 218330 application number: ANDA218330
paliperidone	PALIPERIDONE	Alembic Pharmaceuticals Limited	be30f3cc-55fb-4a74-9778-60573a7f18c6	2024-09-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 218330 application number: ANDA218330 ndc (product): 46708-803

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	be30f3cc-55fb-4a74-9778-60573a7f18c6	1
672567	paliperidone 3 MG 24HR Extended Release Oral Tablet	PSN	be30f3cc-55fb-4a74-9778-60573a7f18c6	1
672569	paliperidone 6 MG 24HR Extended Release Oral Tablet	PSN	be30f3cc-55fb-4a74-9778-60573a7f18c6	1
672571	paliperidone 9 MG 24HR Extended Release Oral Tablet	PSN	be30f3cc-55fb-4a74-9778-60573a7f18c6	1
866103	24 HR paliperidone 1.5 MG Extended Release Oral Tablet	SCD	be30f3cc-55fb-4a74-9778-60573a7f18c6	1
672567	24 HR paliperidone 3 MG Extended Release Oral Tablet	SCD	be30f3cc-55fb-4a74-9778-60573a7f18c6	1
672569	24 HR paliperidone 6 MG Extended Release Oral Tablet	SCD	be30f3cc-55fb-4a74-9778-60573a7f18c6	1
672571	24 HR paliperidone 9 MG Extended Release Oral Tablet	SCD	be30f3cc-55fb-4a74-9778-60573a7f18c6	1
866103	paliperidone 1.5 MG 24 HR Extended Release Oral Tablet	SY	be30f3cc-55fb-4a74-9778-60573a7f18c6	1
672567	paliperidone 3 MG 24 HR Extended Release Oral Tablet	SY	be30f3cc-55fb-4a74-9778-60573a7f18c6	1
672569	paliperidone 6 MG 24 HR Extended Release Oral Tablet	SY	be30f3cc-55fb-4a74-9778-60573a7f18c6	1
672571	paliperidone 9 MG 24 HR Extended Release Oral Tablet	SY	be30f3cc-55fb-4a74-9778-60573a7f18c6	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
46708-803-30	46708080330	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-803-30)	2024-09-30	No	No	Current