INVEGA HAFYERA

Product NDC: 50458-612
11-digit product format: 504580612
Labeler code: 50458
Product ID: 50458-612_2e6ef0e1-19d2-7d78-e063-6394a90ae8a6
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: 2021-08-30
Substance: PALIPERIDONE PALMITATE
Active strength: 1560 mg/5mL
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 HAFYERA
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PALIPERIDONE PALMITATE	1560 mg/5mL

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 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2570418	Internal RxNorm lookup
2570419	Internal RxNorm lookup
2570420	Internal RxNorm lookup
2570421	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
6cd61892-d2cb-434d-83ed-5c1b2c4e7a0b	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
726062af-1135-4707-a1d7-57256991bbf9	Product name	2	20250226
fd328049-536a-4914-b42e-93bf4d93db24	Product name	1	20220307
0f0756fc-4d63-4f75-afcc-9c5e62a38d69	Product name	2	20220304
19c71a3d-ed9c-166b-a7e5-38c250c35631	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50458-612-01	INVEGA HAFYERA	1 in 1 CARTON	INJECTION, SUSPENSION, EXTENDED	1		8
50458-612-01	INVEGA HAFYERA	5 mL in 1 SYRINGE	INJECTION, SUSPENSION, EXTENDED	5		8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50458-612-01	ML - Milliliter	50458-612	be2afd08-d149-4e8a-a080-f1558ff289d8	1	2021-10-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50458-612	INVEGA HAFYERA (PALIPERIDONE PALMITATE) INJECTION, SUSPENSION, EXTENDED RELEASE [JANSSEN PHARMACEUTICALS, INC]	8	Current NDC, Legacy NDC, 2 package rows	20250221_6cd61892-d2cb-434d-83ed-5c1b2c4e7a0b.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 ndc (product): 50458-612
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

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
2570419	Invega Hayfera 1092 MG in 3.5 ML Prefilled Syringe	PSN	6cd61892-d2cb-434d-83ed-5c1b2c4e7a0b	8
2570421	Invega Hayfera 1560 MG in 5 ML Prefilled Syringe	PSN	6cd61892-d2cb-434d-83ed-5c1b2c4e7a0b	8
2570418	paliperidone palmitate 1092 in 3.5 ML Prefilled Syringe	PSN	6cd61892-d2cb-434d-83ed-5c1b2c4e7a0b	8
2570420	paliperidone palmitate 1560 MG in 5 ML Prefilled Syringe	PSN	6cd61892-d2cb-434d-83ed-5c1b2c4e7a0b	8
2570419	3.5 ML paliperidone palmitate 312 MG/ML Prefilled Syringe [Invega]	SBD	6cd61892-d2cb-434d-83ed-5c1b2c4e7a0b	8
2570421	5 ML paliperidone palmitate 312 MG/ML Prefilled Syringe [Invega]	SBD	6cd61892-d2cb-434d-83ed-5c1b2c4e7a0b	8
2570418	3.5 ML paliperidone palmitate 312 MG/ML Prefilled Syringe	SCD	6cd61892-d2cb-434d-83ed-5c1b2c4e7a0b	8
2570420	5 ML paliperidone palmitate 312 MG/ML Prefilled Syringe	SCD	6cd61892-d2cb-434d-83ed-5c1b2c4e7a0b	8
2570419	3.5 ML Invega 312 MG/ML Prefilled Syringe	SY	6cd61892-d2cb-434d-83ed-5c1b2c4e7a0b	8
2570421	5 ML Invega 312 MG/ML Prefilled Syringe	SY	6cd61892-d2cb-434d-83ed-5c1b2c4e7a0b	8
2570419	Invega Hayfera 1092 MG per 3.5 ML Prefilled Syringe	SY	6cd61892-d2cb-434d-83ed-5c1b2c4e7a0b	8
2570421	Invega Hayfera 1560 MG per 5 ML Prefilled Syringe	SY	6cd61892-d2cb-434d-83ed-5c1b2c4e7a0b	8
2570418	paliperidone palmitate 1092 per 3.5 ML Prefilled Syringe	SY	6cd61892-d2cb-434d-83ed-5c1b2c4e7a0b	8
2570420	paliperidone palmitate 1560 MG per 5 ML Prefilled Syringe	SY	6cd61892-d2cb-434d-83ed-5c1b2c4e7a0b	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50458-612-01	50458061201	1 SYRINGE in 1 CARTON (50458-612-01) / 5 mL in 1 SYRINGE	1 syringe	2021-08-30	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
INVEGA HAFYERA	Janssen Pharmaceuticals, Inc \| Eurofins PHAST GmbH \| PHAST Development GmbH & Co. KG \| Janssen Pharmaceutica NV \| Janssen Ortho LLC	2025-02-18	HUMAN PRESCRIPTION DRUG LABEL	8