INVEGA TRINZA

Product NDC: 50458-608
11-digit product format: 504580608
Labeler code: 50458
Product ID: 50458-608_2e1c6fa0-3051-4a53-e063-6294a90ad1c3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: paliperidone palmitate
Dosage form: INJECTION, SUSPENSION, EXTENDED RELEASE
Route: INTRAMUSCULAR
Labeler: Janssen Pharmaceuticals, Inc
Application: NDA207946
Marketing category: NDA
Marketing start: 2015-05-19
Substance: PALIPERIDONE PALMITATE
Active strength: 546 mg/1.75mL
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 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N207946-001	INVEGA TRINZA	PALIPERIDONE PALMITATE	273MG/0.875ML (273MG/0.875ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2015-05-18
N207946-002	INVEGA TRINZA	PALIPERIDONE PALMITATE	410MG/1.315ML (311.79MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2015-05-18
N207946-003	INVEGA TRINZA	PALIPERIDONE PALMITATE	546MG/1.75ML (312MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2015-05-18
N207946-004	INVEGA TRINZA	PALIPERIDONE PALMITATE	819MG/2.625ML (312MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2015-05-18
N207946-005	INVEGA HAFYERA	PALIPERIDONE PALMITATE	1.092GM/3.5ML (312MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2021-08-30
N207946-006	INVEGA HAFYERA	PALIPERIDONE PALMITATE	1.560GM/5ML (312MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2021-08-30

Orange Book patents#

Current patent rows page 1 of 1 · 18 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Submission date
N207946-001	10143693	2036-04-05	U-2457	2018-12-18
N207946-001	10143693	2036-04-05	U-2458	2018-12-18
N207946-002	10143693	2036-04-05	U-2457	2018-12-18
N207946-002	10143693	2036-04-05	U-2458	2018-12-18
N207946-003	10143693	2036-04-05	U-2457	2018-12-18
N207946-003	10143693	2036-04-05	U-2458	2018-12-18
N207946-004	10143693	2036-04-05	U-2457	2018-12-18
N207946-004	10143693	2036-04-05	U-2458	2018-12-18
N207946-005	11304951	2041-05-07	U-3349	2022-04-25
N207946-005	11324751	2041-05-07	U-3359	2022-05-12
N207946-005	12208100	2041-05-07	U-3359	2025-02-06
N207946-005	12208100	2041-05-07	U-4110	2025-02-06
N207946-005	11666697	2041-11-24	U-3626	2023-06-15
N207946-006	11304951	2041-05-07	U-3349	2022-04-25
N207946-006	11324751	2041-05-07	U-3359	2022-05-12
N207946-006	12208100	2041-05-07	U-3359	2025-02-06
N207946-006	12208100	2041-05-07	U-4110	2025-02-06
N207946-006	11666697	2041-11-24	U-3626	2023-06-15

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 6 · 230 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N207946-001	INVEGA TRINZA	273MG/0.875ML (273MG/0.875ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2015-05-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207946-002	INVEGA TRINZA	410MG/1.315ML (311.79MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2015-05-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207946-003	INVEGA TRINZA	546MG/1.75ML (312MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2015-05-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207946-004	INVEGA TRINZA	819MG/2.625ML (312MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2015-05-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207946-005	INVEGA HAFYERA	1.092GM/3.5ML (312MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2021-08-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207946-006	INVEGA HAFYERA	1.560GM/5ML (312MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2021-08-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207946-001	INVEGA TRINZA	273MG/0.875ML (273MG/0.875ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2015-05-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207946-002	INVEGA TRINZA	410MG/1.315ML (311.79MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2015-05-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207946-003	INVEGA TRINZA	546MG/1.75ML (312MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2015-05-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207946-004	INVEGA TRINZA	819MG/2.625ML (312MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2015-05-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207946-005	INVEGA HAFYERA	1.092GM/3.5ML (312MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2021-08-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207946-006	INVEGA HAFYERA	1.560GM/5ML (312MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2021-08-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N207946-001	INVEGA TRINZA	273MG/0.875ML (273MG/0.875ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2015-05-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207946-002	INVEGA TRINZA	410MG/1.315ML (311.79MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2015-05-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207946-003	INVEGA TRINZA	546MG/1.75ML (312MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2015-05-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207946-004	INVEGA TRINZA	819MG/2.625ML (312MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2015-05-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207946-005	INVEGA HAFYERA	1.092GM/3.5ML (312MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2021-08-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207946-006	INVEGA HAFYERA	1.560GM/5ML (312MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2021-08-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207946-001	INVEGA TRINZA	273MG/0.875ML (273MG/0.875ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2015-05-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207946-002	INVEGA TRINZA	410MG/1.315ML (311.79MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2015-05-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207946-003	INVEGA TRINZA	546MG/1.75ML (312MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2015-05-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207946-004	INVEGA TRINZA	819MG/2.625ML (312MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2015-05-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207946-005	INVEGA HAFYERA	1.092GM/3.5ML (312MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2021-08-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207946-006	INVEGA HAFYERA	1.560GM/5ML (312MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2021-08-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N207946-001	INVEGA TRINZA	273MG/0.875ML (273MG/0.875ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2015-05-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N207946-002	INVEGA TRINZA	410MG/1.315ML (311.79MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2015-05-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N207946-003	INVEGA TRINZA	546MG/1.75ML (312MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2015-05-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N207946-004	INVEGA TRINZA	819MG/2.625ML (312MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2015-05-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N207946-005	INVEGA HAFYERA	1.092GM/3.5ML (312MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2021-08-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N207946-006	INVEGA HAFYERA	1.560GM/5ML (312MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2021-08-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N207946-001	INVEGA TRINZA	273MG/0.875ML (273MG/0.875ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2015-05-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N207946-002	INVEGA TRINZA	410MG/1.315ML (311.79MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2015-05-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N207946-003	INVEGA TRINZA	546MG/1.75ML (312MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2015-05-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N207946-004	INVEGA TRINZA	819MG/2.625ML (312MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2015-05-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N207946-005	INVEGA HAFYERA	1.092GM/3.5ML (312MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2021-08-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N207946-006	INVEGA HAFYERA	1.560GM/5ML (312MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2021-08-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N207946-001	INVEGA TRINZA	273MG/0.875ML (273MG/0.875ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2015-05-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N207946-002	INVEGA TRINZA	410MG/1.315ML (311.79MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2015-05-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N207946-003	INVEGA TRINZA	546MG/1.75ML (312MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2015-05-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N207946-004	INVEGA TRINZA	819MG/2.625ML (312MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2015-05-18	`2680178bc6a6…`

Observed Orange Book patent history#

Patent history page 1 of 13 · 510 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N207946-001	10143693	2036-04-05	U-2458	2018-12-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207946-001	10143693	2036-04-05	U-2457	2018-12-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207946-002	10143693	2036-04-05	U-2457	2018-12-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207946-002	10143693	2036-04-05	U-2458	2018-12-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207946-003	10143693	2036-04-05	U-2458	2018-12-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207946-003	10143693	2036-04-05	U-2457	2018-12-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207946-004	10143693	2036-04-05	U-2458	2018-12-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207946-004	10143693	2036-04-05	U-2457	2018-12-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207946-005	11304951	2041-05-07	U-3349	2022-04-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207946-005	11324751	2041-05-07	U-3359	2022-05-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207946-005	12208100	2041-05-07	U-3359	2025-02-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207946-005	12208100	2041-05-07	U-4110	2025-02-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207946-005	11666697	2041-11-24	U-3626	2023-06-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207946-006	11304951	2041-05-07	U-3349	2022-04-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207946-006	11324751	2041-05-07	U-3359	2022-05-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207946-006	12208100	2041-05-07	U-4110	2025-02-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207946-006	12208100	2041-05-07	U-3359	2025-02-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207946-006	11666697	2041-11-24	U-3626	2023-06-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207946-001	10143693	2036-04-05	U-2458	2018-12-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207946-001	10143693	2036-04-05	U-2457	2018-12-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207946-002	10143693	2036-04-05	U-2457	2018-12-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207946-002	10143693	2036-04-05	U-2458	2018-12-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207946-003	10143693	2036-04-05	U-2458	2018-12-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207946-003	10143693	2036-04-05	U-2457	2018-12-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207946-004	10143693	2036-04-05	U-2458	2018-12-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207946-004	10143693	2036-04-05	U-2457	2018-12-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207946-005	11304951	2041-05-07	U-3349	2022-04-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207946-005	11324751	2041-05-07	U-3359	2022-05-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207946-005	12208100	2041-05-07	U-3359	2025-02-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207946-005	12208100	2041-05-07	U-4110	2025-02-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207946-005	11666697	2041-11-24	U-3626	2023-06-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207946-006	11304951	2041-05-07	U-3349	2022-04-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207946-006	11324751	2041-05-07	U-3359	2022-05-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207946-006	12208100	2041-05-07	U-4110	2025-02-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207946-006	12208100	2041-05-07	U-3359	2025-02-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207946-006	11666697	2041-11-24	U-3626	2023-06-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N207946-001	10143693	2036-04-05	U-2458	2018-12-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207946-001	10143693	2036-04-05	U-2457	2018-12-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207946-002	10143693	2036-04-05	U-2457	2018-12-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207946-002	10143693	2036-04-05	U-2458	2018-12-18	`6a471c1ec25d…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 54 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N207946-005	NS	2024-08-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N207946-006	NS	2024-08-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N207946-005	NS	2024-08-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N207946-006	NS	2024-08-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N207946-005	NS	2024-08-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N207946-006	NS	2024-08-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N207946-005	NS	2024-08-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N207946-006	NS	2024-08-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N207946-005	NS	2024-08-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N207946-006	NS	2024-08-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N207946-005	NS	2024-08-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N207946-006	NS	2024-08-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N207946-005	NS	2024-08-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N207946-006	NS	2024-08-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N207946-005	NS	2024-08-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N207946-006	NS	2024-08-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N207946-005	NS	2024-08-30	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N207946-006	NS	2024-08-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N207946-005	NS	2024-08-30	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N207946-006	NS	2024-08-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N207946-005	NS	2024-08-30	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N207946-006	NS	2024-08-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N207946-005	NS	2024-08-30	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N207946-006	NS	2024-08-30	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N207946-005	NS	2024-08-30	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N207946-006	NS	2024-08-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N207946-005	NS	2024-08-30	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N207946-006	NS	2024-08-30	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N207946-005	NS	2024-08-30	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N207946-006	NS	2024-08-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N207946-005	NS	2024-08-30	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N207946-006	NS	2024-08-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N207946-005	NS	2024-08-30	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N207946-006	NS	2024-08-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N207946-005	NS	2024-08-30	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N207946-006	NS	2024-08-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N207946-005	NS	2024-08-30	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N207946-006	NS	2024-08-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N207946-005	NS	2024-08-30	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N207946-006	NS	2024-08-30	`a67488948f0b…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PALIPERIDONE PALMITATE	546 mg/1.75mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
R8P8USM8FR	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 8 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1650966	Internal RxNorm lookup
1650968	Internal RxNorm lookup
1650971	Internal RxNorm lookup
1650972	Internal RxNorm lookup
1650973	Internal RxNorm lookup
1650974	Internal RxNorm lookup
1650975	Internal RxNorm lookup
1650976	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
c39e65d7-fa44-4e4c-8b12-a654d3ed0eae	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
50458-608-01	INVEGA TRINZA	1 mL in 1 SYRINGE	INJECTION, SUSPENSION, EXTENDED	1		25
50458-608-01	INVEGA TRINZA	1 in 1 KIT	INJECTION, SUSPENSION, EXTENDED	1		25

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50458-608-01	ML - Milliliter	50458-608	5b66873a-d2a8-48d9-8596-cc48929890d4	1	2015-07-20

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
paliperidone palmitate	ACTIVE INGREDIENT	R8P8USM8FR	INVEGA TRINZA (PALIPERIDONE PALMITATE) INJECTION, SUSPENSION, EXTENDED RELEASE [JANSSEN PHARMACEUTICALS, INC]	1
paliperidone	ACTIVE MOIETY	838F01T721	INVEGA TRINZA (PALIPERIDONE PALMITATE) INJECTION, SUSPENSION, EXTENDED RELEASE [JANSSEN PHARMACEUTICALS, INC]	1
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	INVEGA TRINZA (PALIPERIDONE PALMITATE) INJECTION, SUSPENSION, EXTENDED RELEASE [JANSSEN PHARMACEUTICALS, INC]	1
POLYETHYLENE GLYCOL 4000	INACTIVE INGREDIENT	4R4HFI6D95	INVEGA TRINZA (PALIPERIDONE PALMITATE) INJECTION, SUSPENSION, EXTENDED RELEASE [JANSSEN PHARMACEUTICALS, INC]	1
POLYSORBATE 20	INACTIVE INGREDIENT	7T1F30V5YH	INVEGA TRINZA (PALIPERIDONE PALMITATE) INJECTION, SUSPENSION, EXTENDED RELEASE [JANSSEN PHARMACEUTICALS, INC]	1
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	INVEGA TRINZA (PALIPERIDONE PALMITATE) INJECTION, SUSPENSION, EXTENDED RELEASE [JANSSEN PHARMACEUTICALS, INC]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	INVEGA TRINZA (PALIPERIDONE PALMITATE) INJECTION, SUSPENSION, EXTENDED RELEASE [JANSSEN PHARMACEUTICALS, INC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50458-608	INVEGA TRINZA (PALIPERIDONE PALMITATE) INJECTION, SUSPENSION, EXTENDED RELEASE [JANSSEN PHARMACEUTICALS, INC]	25	Current NDC, Legacy NDC, 2 package rows	20250216_c39e65d7-fa44-4e4c-8b12-a654d3ed0eae.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
INVEGA HAFYERA	PALIPERIDONE PALMITATE	Janssen Pharmaceuticals, Inc	6cd61892-d2cb-434d-83ed-5c1b2c4e7a0b	2025-02-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 207946 application number: NDA207946
INVEGA TRINZA	PALIPERIDONE PALMITATE	Janssen Pharmaceuticals, Inc	c39e65d7-fa44-4e4c-8b12-a654d3ed0eae	2025-02-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 207946 application number: NDA207946 ndc (product): 50458-608

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
R8P8USM8FR	PALIPERIDONE PALMITATE	199739-10-1	PALIPERIDONE PALMITATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1650968	Invega Trinza 273 MG in 0.88 ML Prefilled Syringe	PSN	c39e65d7-fa44-4e4c-8b12-a654d3ed0eae	25
1650972	Invega Trinza 410 MG in 1.32 ML Prefilled Syringe	PSN	c39e65d7-fa44-4e4c-8b12-a654d3ed0eae	25
1650974	Invega Trinza 546 MG in 1.75 ML Prefilled Syringe	PSN	c39e65d7-fa44-4e4c-8b12-a654d3ed0eae	25
1650976	Invega Trinza 819 MG in 2.63 ML Prefilled Syringe	PSN	c39e65d7-fa44-4e4c-8b12-a654d3ed0eae	25
1650966	paliperidone palmitate 273 MG in 0.88 ML Prefilled Syringe	PSN	c39e65d7-fa44-4e4c-8b12-a654d3ed0eae	25
1650971	paliperidone palmitate 410 MG in 1.32 ML Prefilled Syringe	PSN	c39e65d7-fa44-4e4c-8b12-a654d3ed0eae	25
1650973	paliperidone palmitate 546 MG in 1.75 ML Prefilled Syringe	PSN	c39e65d7-fa44-4e4c-8b12-a654d3ed0eae	25
1650975	paliperidone palmitate 819 MG in 2.63 ML Prefilled Syringe	PSN	c39e65d7-fa44-4e4c-8b12-a654d3ed0eae	25
1650968	0.88 ML paliperidone palmitate 310 MG/ML Prefilled Syringe [Invega]	SBD	c39e65d7-fa44-4e4c-8b12-a654d3ed0eae	25
1650972	1.32 ML paliperidone palmitate 311 MG/ML Prefilled Syringe [Invega]	SBD	c39e65d7-fa44-4e4c-8b12-a654d3ed0eae	25
1650974	1.75 ML paliperidone palmitate 312 MG/ML Prefilled Syringe [Invega]	SBD	c39e65d7-fa44-4e4c-8b12-a654d3ed0eae	25
1650976	2.63 ML paliperidone palmitate 311 MG/ML Prefilled Syringe [Invega]	SBD	c39e65d7-fa44-4e4c-8b12-a654d3ed0eae	25
1650966	0.88 ML paliperidone palmitate 310 MG/ML Prefilled Syringe	SCD	c39e65d7-fa44-4e4c-8b12-a654d3ed0eae	25
1650971	1.32 ML paliperidone palmitate 311 MG/ML Prefilled Syringe	SCD	c39e65d7-fa44-4e4c-8b12-a654d3ed0eae	25
1650973	1.75 ML paliperidone palmitate 312 MG/ML Prefilled Syringe	SCD	c39e65d7-fa44-4e4c-8b12-a654d3ed0eae	25
1650975	2.63 ML paliperidone palmitate 311 MG/ML Prefilled Syringe	SCD	c39e65d7-fa44-4e4c-8b12-a654d3ed0eae	25
1650968	0.88 ML Invega 310 MG/ML Prefilled Syringe	SY	c39e65d7-fa44-4e4c-8b12-a654d3ed0eae	25
1650972	1.32 ML Invega 311 MG/ML Prefilled Syringe	SY	c39e65d7-fa44-4e4c-8b12-a654d3ed0eae	25
1650974	1.75 ML Invega 312 MG/ML Prefilled Syringe	SY	c39e65d7-fa44-4e4c-8b12-a654d3ed0eae	25
1650976	2.63 ML Invega 311 MG/ML Prefilled Syringe	SY	c39e65d7-fa44-4e4c-8b12-a654d3ed0eae	25
1650968	Invega 273 MG per 0.88 ML Prefilled Syringe	SY	c39e65d7-fa44-4e4c-8b12-a654d3ed0eae	25
1650972	Invega 410 MG per 1.32 ML Prefilled Syringe	SY	c39e65d7-fa44-4e4c-8b12-a654d3ed0eae	25
1650974	Invega 546 MG per 1.75 ML Prefilled Syringe	SY	c39e65d7-fa44-4e4c-8b12-a654d3ed0eae	25
1650976	Invega 819 MG per 2.63 ML Prefilled Syringe	SY	c39e65d7-fa44-4e4c-8b12-a654d3ed0eae	25
1650966	paliperidone palmitate 273 MG per 0.88 ML Prefilled Syringe	SY	c39e65d7-fa44-4e4c-8b12-a654d3ed0eae	25
1650971	paliperidone palmitate 410 MG per 1.32 ML Prefilled Syringe	SY	c39e65d7-fa44-4e4c-8b12-a654d3ed0eae	25
1650973	paliperidone palmitate 546 MG per 1.75 ML Prefilled Syringe	SY	c39e65d7-fa44-4e4c-8b12-a654d3ed0eae	25
1650975	paliperidone palmitate 819 MG per 2.63 ML Prefilled Syringe	SY	c39e65d7-fa44-4e4c-8b12-a654d3ed0eae	25

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50458-608-01	50458060801	1 SYRINGE in 1 KIT (50458-608-01) / 1 mL in 1 SYRINGE	1 syringe	2015-05-19	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
INVEGA TRINZA	Janssen Pharmaceuticals, Inc \| Phast \| Janssen Pharmaceutica NV \| Janssen-Cilag Manufacturing, LLC \| Janssen Pharmaceutical Sciences Unlimited Company	2025-02-14	HUMAN PRESCRIPTION DRUG LABEL	25