Vraylar

Product NDC: 61874-160
11-digit product format: 618740160
Labeler code: 61874
Product ID: 61874-160_db2154b0-f0c7-403c-95fd-794666e79e30
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: cariprazine
Dosage form: CAPSULE, GELATIN COATED
Route: ORAL
Labeler: Allergan, Inc.
Application: NDA204370
Marketing category: NDA
Marketing start: 2015-09-17
Substance: CARIPRAZINE
Active strength: 6 mg/1
Pharmacologic classes: Atypical Antipsychotic [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	61874-160	61874-160-90	D	Discontinued by firm		2026-08-10

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
N204370-001	VRAYLAR	CARIPRAZINE HYDROCHLORIDE	EQ 1.5MG BASE	CAPSULE / ORAL	RLD, RS	2015-09-17
N204370-002	VRAYLAR	CARIPRAZINE HYDROCHLORIDE	EQ 3MG BASE	CAPSULE / ORAL	RLD	2015-09-17
N204370-003	VRAYLAR	CARIPRAZINE HYDROCHLORIDE	EQ 4.5MG BASE	CAPSULE / ORAL	RLD	2015-09-17
N204370-004	VRAYLAR	CARIPRAZINE HYDROCHLORIDE	EQ 6MG BASE	CAPSULE / ORAL	RLD	2015-09-17
N204370-005	VRAYLAR	CARIPRAZINE HYDROCHLORIDE	EQ 0.5MG BASE	CAPSULE / ORAL	RLD	2025-12-18
N204370-006	VRAYLAR	CARIPRAZINE HYDROCHLORIDE	EQ 0.75MG BASE	CAPSULE / ORAL	RLD	2025-12-18

Orange Book patents#

Current patent rows page 1 of 2 · 106 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N204370-001	7943621	2028-12-16		Drug substance, Drug product	2015-10-16
N204370-001	7943621*PED	2029-06-16		Pediatric extension
N204370-001	RE47350	2029-07-16	U-1750		2019-05-15
N204370-001	RE47350	2029-07-16	U-2543		2019-05-15
N204370-001	RE47350	2029-07-16	U-2544		2019-05-15
N204370-001	RE47350	2029-07-16	U-2545		2019-05-15
N204370-001	RE47350	2029-07-16	U-3503		2019-05-15
N204370-001	RE49110	2029-07-16	U-2543		2022-07-21
N204370-001	RE49110	2029-07-16	U-2544		2022-07-21
N204370-001	RE49110	2029-07-16	U-2545		2022-07-21
N204370-001	RE49110	2029-07-16	U-3503		2022-07-21
N204370-001	RE49302	2029-07-16	U-2543		2023-01-13
N204370-001	RE49302	2029-07-16	U-2544		2023-01-13
N204370-001	RE49302	2029-07-16	U-2545		2023-01-13
N204370-001	RE49302	2029-07-16	U-3503		2023-01-13
N204370-001	7737142	2029-09-17	U-1750	Drug substance, Drug product	2015-10-16
N204370-001	7737142	2029-09-17	U-2543	Drug substance, Drug product	2015-10-16
N204370-001	7737142	2029-09-17	U-2544	Drug substance, Drug product	2015-10-16
N204370-001	7737142	2029-09-17	U-2545	Drug substance, Drug product	2015-10-16
N204370-001	7737142	2029-09-17	U-3503	Drug substance, Drug product	2015-10-16
N204370-001	RE47350*PED	2030-01-16		Pediatric extension
N204370-001	RE49110*PED	2030-01-16		Pediatric extension
N204370-001	RE49302*PED	2030-01-16		Pediatric extension
N204370-001	7737142*PED	2030-03-17		Pediatric extension
N204370-002	7943621	2028-12-16		Drug substance, Drug product	2015-10-16
N204370-002	7943621*PED	2029-06-16		Pediatric extension
N204370-002	RE49110	2029-07-16	U-2543		2022-07-21
N204370-002	RE49110	2029-07-16	U-2544		2022-07-21
N204370-002	RE49110	2029-07-16	U-2545		2022-07-21
N204370-002	RE49110	2029-07-16	U-3503		2022-07-21
N204370-002	RE49302	2029-07-16	U-2543		2023-01-13
N204370-002	RE49302	2029-07-16	U-2544		2023-01-13
N204370-002	RE49302	2029-07-16	U-2545		2023-01-13
N204370-002	RE49302	2029-07-16	U-3503		2023-01-13
N204370-002	7737142	2029-09-17	U-1750	Drug substance, Drug product	2015-10-16
N204370-002	7737142	2029-09-17	U-2543	Drug substance, Drug product	2015-10-16
N204370-002	7737142	2029-09-17	U-2544	Drug substance, Drug product	2015-10-16
N204370-002	7737142	2029-09-17	U-2545	Drug substance, Drug product	2015-10-16
N204370-002	7737142	2029-09-17	U-3503	Drug substance, Drug product	2015-10-16
N204370-002	RE49110*PED	2030-01-16		Pediatric extension
N204370-002	RE49302*PED	2030-01-16		Pediatric extension
N204370-002	7737142*PED	2030-03-17		Pediatric extension
N204370-003	7943621	2028-12-16		Drug substance, Drug product	2015-10-16
N204370-003	7943621*PED	2029-06-16		Pediatric extension
N204370-003	RE49110	2029-07-16	U-2543		2022-07-21
N204370-003	RE49110	2029-07-16	U-2544		2022-07-21
N204370-003	RE49110	2029-07-16	U-2545		2022-07-21
N204370-003	RE49302	2029-07-16	U-2543		2023-01-13
N204370-003	RE49302	2029-07-16	U-2544		2023-01-13
N204370-003	RE49302	2029-07-16	U-2545		2023-01-13
N204370-003	RE49302	2029-07-16	U-3503		2023-01-13
N204370-003	7737142	2029-09-17	U-1750	Drug substance, Drug product	2015-10-16
N204370-003	7737142	2029-09-17	U-2543	Drug substance, Drug product	2015-10-16
N204370-003	7737142	2029-09-17	U-2544	Drug substance, Drug product	2015-10-16
N204370-003	RE49110*PED	2030-01-16		Pediatric extension
N204370-003	RE49302*PED	2030-01-16		Pediatric extension
N204370-003	7737142*PED	2030-03-17		Pediatric extension
N204370-004	7943621	2028-12-16		Drug substance, Drug product	2015-10-16
N204370-004	7943621*PED	2029-06-16		Pediatric extension
N204370-004	RE49110	2029-07-16	U-2543		2022-07-21
N204370-004	RE49110	2029-07-16	U-2544		2022-07-21
N204370-004	RE49110	2029-07-16	U-2545		2022-07-21
N204370-004	RE49302	2029-07-16	U-2543		2023-01-13
N204370-004	RE49302	2029-07-16	U-2544		2023-01-13
N204370-004	RE49302	2029-07-16	U-2545		2023-01-13
N204370-004	RE49302	2029-07-16	U-3503		2023-01-13
N204370-004	7737142	2029-09-17	U-1750	Drug substance, Drug product	2015-10-16
N204370-004	7737142	2029-09-17	U-2543	Drug substance, Drug product	2015-10-16
N204370-004	7737142	2029-09-17	U-2544	Drug substance, Drug product	2015-10-16
N204370-004	RE49110*PED	2030-01-16		Pediatric extension
N204370-004	RE49302*PED	2030-01-16		Pediatric extension
N204370-004	7737142*PED	2030-03-17		Pediatric extension
N204370-005	7943621	2028-12-20		Drug substance, Drug product	2026-01-14
N204370-005	7943621*PED	2029-06-20		Pediatric extension
N204370-005	RE47350	2029-07-16	U-2543		2026-01-14
N204370-005	RE47350	2029-07-16	U-2544		2026-01-14
N204370-005	RE47350	2029-07-16	U-2545		2026-01-14
N204370-005	RE47350	2029-07-16	U-3503		2026-01-14
N204370-005	RE49110	2029-07-16	U-2543		2026-01-14
N204370-005	RE49110	2029-07-16	U-2544		2026-01-14

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 22 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N204370-001	M-14	2028-12-18
N204370-001	NPP	2028-12-18
N204370-001	PED	2029-06-18
N204370-001	PED	2029-06-18
N204370-002	M-14	2028-12-18
N204370-002	NPP	2028-12-18
N204370-002	PED	2029-06-18
N204370-002	PED	2029-06-18
N204370-003	M-14	2028-12-18
N204370-003	NPP	2028-12-18
N204370-003	PED	2029-06-18
N204370-003	PED	2029-06-18
N204370-004	M-14	2028-12-18
N204370-004	PED	2029-06-18
N204370-005	M-14	2028-12-18
N204370-005	NPP	2028-12-18
N204370-005	PED	2029-06-18
N204370-005	PED	2029-06-18
N204370-006	M-14	2028-12-18
N204370-006	NPP	2028-12-18
N204370-006	PED	2029-06-18
N204370-006	PED	2029-06-18

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 · 168 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	N204370-001	VRAYLAR	EQ 1.5MG BASE	CAPSULE / ORAL	RLD, RS	2015-09-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204370-002	VRAYLAR	EQ 3MG BASE	CAPSULE / ORAL	RLD	2015-09-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204370-003	VRAYLAR	EQ 4.5MG BASE	CAPSULE / ORAL	RLD	2015-09-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204370-004	VRAYLAR	EQ 6MG BASE	CAPSULE / ORAL	RLD	2015-09-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204370-005	VRAYLAR	EQ 0.5MG BASE	CAPSULE / ORAL	RLD	2025-12-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204370-006	VRAYLAR	EQ 0.75MG BASE	CAPSULE / ORAL	RLD	2025-12-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204370-001	VRAYLAR	EQ 1.5MG BASE	CAPSULE / ORAL	RLD, RS	2015-09-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204370-002	VRAYLAR	EQ 3MG BASE	CAPSULE / ORAL	RLD	2015-09-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204370-003	VRAYLAR	EQ 4.5MG BASE	CAPSULE / ORAL	RLD	2015-09-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204370-004	VRAYLAR	EQ 6MG BASE	CAPSULE / ORAL	RLD	2015-09-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N204370-001	VRAYLAR	EQ 1.5MG BASE	CAPSULE / ORAL	RLD, RS	2015-09-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204370-002	VRAYLAR	EQ 3MG BASE	CAPSULE / ORAL	RLD	2015-09-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204370-003	VRAYLAR	EQ 4.5MG BASE	CAPSULE / ORAL	RLD	2015-09-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204370-004	VRAYLAR	EQ 6MG BASE	CAPSULE / ORAL	RLD	2015-09-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204370-001	VRAYLAR	EQ 1.5MG BASE	CAPSULE / ORAL	RLD, RS	2015-09-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204370-002	VRAYLAR	EQ 3MG BASE	CAPSULE / ORAL	RLD	2015-09-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204370-003	VRAYLAR	EQ 4.5MG BASE	CAPSULE / ORAL	RLD	2015-09-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204370-004	VRAYLAR	EQ 6MG BASE	CAPSULE / ORAL	RLD	2015-09-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204370-001	VRAYLAR	EQ 1.5MG BASE	CAPSULE / ORAL	RLD, RS	2015-09-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204370-002	VRAYLAR	EQ 3MG BASE	CAPSULE / ORAL	RLD	2015-09-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204370-003	VRAYLAR	EQ 4.5MG BASE	CAPSULE / ORAL	RLD	2015-09-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204370-004	VRAYLAR	EQ 6MG BASE	CAPSULE / ORAL	RLD	2015-09-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204370-001	VRAYLAR	EQ 1.5MG BASE	CAPSULE / ORAL	RLD, RS	2015-09-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204370-002	VRAYLAR	EQ 3MG BASE	CAPSULE / ORAL	RLD	2015-09-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204370-003	VRAYLAR	EQ 4.5MG BASE	CAPSULE / ORAL	RLD	2015-09-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204370-004	VRAYLAR	EQ 6MG BASE	CAPSULE / ORAL	RLD	2015-09-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204370-001	VRAYLAR	EQ 1.5MG BASE	CAPSULE / ORAL	RLD, RS	2015-09-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204370-002	VRAYLAR	EQ 3MG BASE	CAPSULE / ORAL	RLD	2015-09-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204370-003	VRAYLAR	EQ 4.5MG BASE	CAPSULE / ORAL	RLD	2015-09-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204370-004	VRAYLAR	EQ 6MG BASE	CAPSULE / ORAL	RLD	2015-09-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204370-001	VRAYLAR	EQ 1.5MG BASE	CAPSULE / ORAL	RLD, RS	2015-09-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204370-002	VRAYLAR	EQ 3MG BASE	CAPSULE / ORAL	RLD	2015-09-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204370-003	VRAYLAR	EQ 4.5MG BASE	CAPSULE / ORAL	RLD	2015-09-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204370-004	VRAYLAR	EQ 6MG BASE	CAPSULE / ORAL	RLD	2015-09-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204370-001	VRAYLAR	EQ 1.5MG BASE	CAPSULE / ORAL	RLD, RS	2015-09-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204370-002	VRAYLAR	EQ 3MG BASE	CAPSULE / ORAL	RLD	2015-09-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204370-003	VRAYLAR	EQ 4.5MG BASE	CAPSULE / ORAL	RLD	2015-09-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204370-004	VRAYLAR	EQ 6MG BASE	CAPSULE / ORAL	RLD	2015-09-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N204370-001	VRAYLAR	EQ 1.5MG BASE	CAPSULE / ORAL	RLD, RS	2015-09-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N204370-002	VRAYLAR	EQ 3MG BASE	CAPSULE / ORAL	RLD	2015-09-17	`d06236e962d9…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N204370-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N204370-002	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N204370-003	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N204370-004	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N204370-001	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N204370-002	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N204370-003	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N204370-004	AB	1	`f41ea6bd6efb…`

Observed Orange Book patent history#

Patent history page 1 of 45 · 1,786 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N204370-001	7943621	2028-12-16		Drug substance, Drug product	2015-10-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204370-001	RE47350	2029-07-16	U-1750		2019-05-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204370-001	RE47350	2029-07-16	U-2543		2019-05-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204370-001	RE47350	2029-07-16	U-3503		2019-05-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204370-001	RE47350	2029-07-16	U-2544		2019-05-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204370-001	RE47350	2029-07-16	U-2545		2019-05-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204370-001	RE49110	2029-07-16	U-2545		2022-07-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204370-001	RE49110	2029-07-16	U-2544		2022-07-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204370-001	RE49110	2029-07-16	U-2543		2022-07-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204370-001	RE49110	2029-07-16	U-3503		2022-07-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204370-001	RE49302	2029-07-16	U-2543		2023-01-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204370-001	RE49302	2029-07-16	U-3503		2023-01-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204370-001	RE49302	2029-07-16	U-2544		2023-01-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204370-001	RE49302	2029-07-16	U-2545		2023-01-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204370-001	7737142	2029-09-17	U-2544	Drug substance, Drug product	2015-10-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204370-001	7737142	2029-09-17	U-2545	Drug substance, Drug product	2015-10-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204370-001	7737142	2029-09-17	U-2543	Drug substance, Drug product	2015-10-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204370-001	7737142	2029-09-17	U-1750	Drug substance, Drug product	2015-10-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204370-001	7737142	2029-09-17	U-3503	Drug substance, Drug product	2015-10-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204370-002	7943621	2028-12-16		Drug substance, Drug product	2015-10-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204370-002	RE49110	2029-07-16	U-2545		2022-07-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204370-002	RE49110	2029-07-16	U-2543		2022-07-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204370-002	RE49110	2029-07-16	U-2544		2022-07-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204370-002	RE49110	2029-07-16	U-3503		2022-07-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204370-002	RE49302	2029-07-16	U-2543		2023-01-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204370-002	RE49302	2029-07-16	U-2545		2023-01-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204370-002	RE49302	2029-07-16	U-2544		2023-01-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204370-002	RE49302	2029-07-16	U-3503		2023-01-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204370-002	7737142	2029-09-17	U-2545	Drug substance, Drug product	2015-10-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204370-002	7737142	2029-09-17	U-2544	Drug substance, Drug product	2015-10-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204370-002	7737142	2029-09-17	U-1750	Drug substance, Drug product	2015-10-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204370-002	7737142	2029-09-17	U-3503	Drug substance, Drug product	2015-10-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204370-002	7737142	2029-09-17	U-2543	Drug substance, Drug product	2015-10-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204370-003	7943621	2028-12-16		Drug substance, Drug product	2015-10-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204370-003	RE49110	2029-07-16	U-2544		2022-07-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204370-003	RE49110	2029-07-16	U-2543		2022-07-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204370-003	RE49110	2029-07-16	U-2545		2022-07-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204370-003	RE49302	2029-07-16	U-2543		2023-01-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204370-003	RE49302	2029-07-16	U-2544		2023-01-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204370-003	RE49302	2029-07-16	U-3503		2023-01-13	`011fe1cb6892…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 6 · 226 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204370-001	I-904	2025-12-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204370-002	I-904	2025-12-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204370-003	I-904	2025-12-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204370-004	I-904	2025-12-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N204370-001	I-904	2025-12-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204370-002	I-904	2025-12-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204370-003	I-904	2025-12-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204370-004	I-904	2025-12-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204370-001	I-904	2025-12-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204370-002	I-904	2025-12-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204370-003	I-904	2025-12-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204370-004	I-904	2025-12-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204370-001	I-904	2025-12-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204370-002	I-904	2025-12-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204370-003	I-904	2025-12-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204370-004	I-904	2025-12-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204370-001	I-904	2025-12-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204370-002	I-904	2025-12-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204370-003	I-904	2025-12-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204370-004	I-904	2025-12-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204370-001	I-904	2025-12-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204370-002	I-904	2025-12-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204370-003	I-904	2025-12-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204370-004	I-904	2025-12-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204370-001	I-904	2025-12-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204370-002	I-904	2025-12-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204370-003	I-904	2025-12-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204370-004	I-904	2025-12-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204370-001	I-904	2025-12-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204370-002	I-904	2025-12-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204370-003	I-904	2025-12-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204370-004	I-904	2025-12-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N204370-001	I-904	2025-12-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N204370-002	I-904	2025-12-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N204370-003	I-904	2025-12-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N204370-004	I-904	2025-12-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N204370-001	I-904	2025-12-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N204370-002	I-904	2025-12-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N204370-003	I-904	2025-12-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N204370-004	I-904	2025-12-16	`79d66fd596c7…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CARIPRAZINE	6 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
F6RJL8B278	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 14 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1667660	Internal RxNorm lookup
1667666	Internal RxNorm lookup
1667668	Internal RxNorm lookup
1667670	Internal RxNorm lookup
1667672	Internal RxNorm lookup
1667674	Internal RxNorm lookup
1667676	Internal RxNorm lookup
1667678	Internal RxNorm lookup
1741746	Internal RxNorm lookup
1741747	Internal RxNorm lookup
2729792	Internal RxNorm lookup
2729794	Internal RxNorm lookup
2729796	Internal RxNorm lookup
2729798	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
4b5f7c65-aa2d-452a-b3db-bc85c06ff12f	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
8bcf2fc0-7296-43a8-8a9f-34fc790c26bc	Product name	1	20150929

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
61874-160-07	Vraylar	7 in 1 BLISTER PACK	CAPSULE, GELATIN COATED	7	30
61874-160-30	Vraylar	30 in 1 BOTTLE	CAPSULE, GELATIN COATED	30	30
61874-160-90	Vraylar	90 in 1 BOTTLE	CAPSULE, GELATIN COATED	90	30

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
61874-160-30	EA - Each	61874-160	2f75520f-5c6d-4a65-bf42-33cb0da229e4	1	2016-03-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
cariprazine	ACTIVE INGREDIENT	F6RJL8B278	VRAYLAR (CARIPRAZINE) CAPSULE, GELATIN COATED [ACTAVIS PHARMA, INC.]	2
cariprazine	ACTIVE MOIETY	F6RJL8B278	VRAYLAR (CARIPRAZINE) CAPSULE, GELATIN COATED [ACTAVIS PHARMA, INC.]	2
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	VRAYLAR (CARIPRAZINE) CAPSULE, GELATIN COATED [ACTAVIS PHARMA, INC.]	2
FD&C RED NO. 3	INACTIVE INGREDIENT	PN2ZH5LOQY	VRAYLAR (CARIPRAZINE) CAPSULE, GELATIN COATED [ACTAVIS PHARMA, INC.]	2
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	VRAYLAR (CARIPRAZINE) CAPSULE, GELATIN COATED [ACTAVIS PHARMA, INC.]	2
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	VRAYLAR (CARIPRAZINE) CAPSULE, GELATIN COATED [ACTAVIS PHARMA, INC.]	2
ferrosoferric oxide	INACTIVE INGREDIENT	XM0M87F357	VRAYLAR (CARIPRAZINE) CAPSULE, GELATIN COATED [ACTAVIS PHARMA, INC.]	2
gelatin	INACTIVE INGREDIENT	2G86QN327L	VRAYLAR (CARIPRAZINE) CAPSULE, GELATIN COATED [ACTAVIS PHARMA, INC.]	2
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	VRAYLAR (CARIPRAZINE) CAPSULE, GELATIN COATED [ACTAVIS PHARMA, INC.]	2
shellac	INACTIVE INGREDIENT	46N107B71O	VRAYLAR (CARIPRAZINE) CAPSULE, GELATIN COATED [ACTAVIS PHARMA, INC.]	2
starch, corn	INACTIVE INGREDIENT	O8232NY3SJ	VRAYLAR (CARIPRAZINE) CAPSULE, GELATIN COATED [ACTAVIS PHARMA, INC.]	2
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	VRAYLAR (CARIPRAZINE) CAPSULE, GELATIN COATED [ACTAVIS PHARMA, INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61874-160	VRAYLAR (CARIPRAZINE) CAPSULE, GELATIN COATED VRAYLAR (CARIPRAZINE) KIT [ALLERGAN, INC.]	26	Current NDC, Legacy NDC, 3 package rows	20241206_4b5f7c65-aa2d-452a-b3db-bc85c06ff12f.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
Vraylar	CARIPRAZINE	Allergan, Inc.	4b5f7c65-aa2d-452a-b3db-bc85c06ff12f	2025-12-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 204370 application number: NDA204370 ndc (product): 61874-160

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
F6RJL8B278	CARIPRAZINE	839712-12-8	CARIPRAZINE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1741747	{1 (cariprazine 1.5 MG Oral Capsule [Vraylar]) / 6 (cariprazine 3 MG Oral Capsule [Vraylar]) } Pack [Vraylar 1.5/3 Mixed Pack]	BPCK	4b5f7c65-aa2d-452a-b3db-bc85c06ff12f	30
1741746	{1 (cariprazine 1.5 MG Oral Capsule) / 6 (cariprazine 3 MG Oral Capsule) } Pack	GPCK	4b5f7c65-aa2d-452a-b3db-bc85c06ff12f	30
2729792	cariprazine 0.5 MG Oral Capsule	PSN	4b5f7c65-aa2d-452a-b3db-bc85c06ff12f	30
2729796	cariprazine 0.75 MG Oral Capsule	PSN	4b5f7c65-aa2d-452a-b3db-bc85c06ff12f	30
1667660	cariprazine 1.5 MG Oral Capsule	PSN	4b5f7c65-aa2d-452a-b3db-bc85c06ff12f	30
1741746	cariprazine 1.5/3 mixed pack	PSN	4b5f7c65-aa2d-452a-b3db-bc85c06ff12f	30
1667668	cariprazine 3 MG Oral Capsule	PSN	4b5f7c65-aa2d-452a-b3db-bc85c06ff12f	30
1667672	cariprazine 4.5 MG Oral Capsule	PSN	4b5f7c65-aa2d-452a-b3db-bc85c06ff12f	30
1667676	cariprazine 6 MG Oral Capsule	PSN	4b5f7c65-aa2d-452a-b3db-bc85c06ff12f	30
2729794	Vraylar 0.5 MG Oral Capsule	PSN	4b5f7c65-aa2d-452a-b3db-bc85c06ff12f	30
2729798	Vraylar 0.75 MG Oral Capsule	PSN	4b5f7c65-aa2d-452a-b3db-bc85c06ff12f	30
1667666	Vraylar 1.5 MG Oral Capsule	PSN	4b5f7c65-aa2d-452a-b3db-bc85c06ff12f	30
1741747	Vraylar 1.5/3 Mixed Pack	PSN	4b5f7c65-aa2d-452a-b3db-bc85c06ff12f	30
1667670	Vraylar 3 MG Oral Capsule	PSN	4b5f7c65-aa2d-452a-b3db-bc85c06ff12f	30
1667674	Vraylar 4.5 MG Oral Capsule	PSN	4b5f7c65-aa2d-452a-b3db-bc85c06ff12f	30
1667678	Vraylar 6 MG Oral Capsule	PSN	4b5f7c65-aa2d-452a-b3db-bc85c06ff12f	30
2729794	cariprazine 0.5 MG Oral Capsule [Vraylar]	SBD	4b5f7c65-aa2d-452a-b3db-bc85c06ff12f	30
2729798	cariprazine 0.75 MG Oral Capsule [Vraylar]	SBD	4b5f7c65-aa2d-452a-b3db-bc85c06ff12f	30
1667666	cariprazine 1.5 MG Oral Capsule [Vraylar]	SBD	4b5f7c65-aa2d-452a-b3db-bc85c06ff12f	30
1667670	cariprazine 3 MG Oral Capsule [Vraylar]	SBD	4b5f7c65-aa2d-452a-b3db-bc85c06ff12f	30
1667674	cariprazine 4.5 MG Oral Capsule [Vraylar]	SBD	4b5f7c65-aa2d-452a-b3db-bc85c06ff12f	30
1667678	cariprazine 6 MG Oral Capsule [Vraylar]	SBD	4b5f7c65-aa2d-452a-b3db-bc85c06ff12f	30
2729792	cariprazine 0.5 MG Oral Capsule	SCD	4b5f7c65-aa2d-452a-b3db-bc85c06ff12f	30
2729796	cariprazine 0.75 MG Oral Capsule	SCD	4b5f7c65-aa2d-452a-b3db-bc85c06ff12f	30
1667660	cariprazine 1.5 MG Oral Capsule	SCD	4b5f7c65-aa2d-452a-b3db-bc85c06ff12f	30
1667668	cariprazine 3 MG Oral Capsule	SCD	4b5f7c65-aa2d-452a-b3db-bc85c06ff12f	30
1667672	cariprazine 4.5 MG Oral Capsule	SCD	4b5f7c65-aa2d-452a-b3db-bc85c06ff12f	30
1667676	cariprazine 6 MG Oral Capsule	SCD	4b5f7c65-aa2d-452a-b3db-bc85c06ff12f	30
2729792	cariprazine (as cariprazine hydrochloride) 0.5 MG Oral Capsule	SY	4b5f7c65-aa2d-452a-b3db-bc85c06ff12f	30
2729796	cariprazine (as cariprazine hydrochloride) 0.75 MG Oral Capsule	SY	4b5f7c65-aa2d-452a-b3db-bc85c06ff12f	30
1741746	cariprazine 1.5/3 mixed pack	SY	4b5f7c65-aa2d-452a-b3db-bc85c06ff12f	30
2729794	Vraylar 0.5 MG Oral Capsule	SY	4b5f7c65-aa2d-452a-b3db-bc85c06ff12f	30
2729798	Vraylar 0.75 MG Oral Capsule	SY	4b5f7c65-aa2d-452a-b3db-bc85c06ff12f	30
1667666	Vraylar 1.5 MG Oral Capsule	SY	4b5f7c65-aa2d-452a-b3db-bc85c06ff12f	30
1741747	Vraylar 1.5/3 Mixed Pack	SY	4b5f7c65-aa2d-452a-b3db-bc85c06ff12f	30
1667670	Vraylar 3 MG Oral Capsule	SY	4b5f7c65-aa2d-452a-b3db-bc85c06ff12f	30
1667674	Vraylar 4.5 MG Oral Capsule	SY	4b5f7c65-aa2d-452a-b3db-bc85c06ff12f	30
1667678	Vraylar 6 MG Oral Capsule	SY	4b5f7c65-aa2d-452a-b3db-bc85c06ff12f	30

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
61874-160-07	61874016007	7 CAPSULE, GELATIN COATED in 1 BLISTER PACK (61874-160-07)	2016-03-01	0000-00-00	Yes	No	Current
61874-160-30	61874016030	30 CAPSULE, GELATIN COATED in 1 BOTTLE (61874-160-30)	2016-03-01	0000-00-00	No	No	Current
61874-160-90	61874016090	90 in 1 BOTTLE					Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Vraylar - Allergan, Inc.	Allergan, Inc.	2025-12-18	HUMAN PRESCRIPTION DRUG LABEL	30
Vraylar - REMEDYREPACK INC.	REMEDYREPACK INC.	2024-03-13	HUMAN PRESCRIPTION DRUG LABEL	4