Home NDC 70518-3157-0 Vraylar
Product NDC 70518-3157
Requested package NDC 70518-3157-0
11-digit product format 705183157
Labeler code 70518
Product ID 70518-3157_ed349745-ecdc-ad42-e053-2a95a90a7533
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name cariprazine
Dosage form CAPSULE, GELATIN COATED
Route ORAL
Labeler REMEDYREPACK INC.
Application NDA204370
Marketing category NDA
Marketing start 2021-07-15
Marketing end 0000-00-00
Substance CARIPRAZINE
Active strength 6 mg/1
Pharmacologic classes Atypical Antipsychotic [EPC]
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record 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 · 11 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…
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 TE codes 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.
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 Product TE source text 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# 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.
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
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 70518-3157-0 70518315700 30 POUCH in 1 BOX (70518-3157-0) > 1 CAPSULE, GELATIN COATED in 1 POUCH (70518-3157-1) 30 pouch 2021-07-15 0000-00-00 No No Current