Home NDC 59148-031-72 Abilify MyCite
Product NDC 59148-031
Requested package NDC 59148-031-72
11-digit product format 591480031
Labeler code 59148
Product ID 59148-031_3cbd66b3-7c90-44fc-9c44-3f290e6144e6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ARIPIPRAZOLE
Dosage form TABLET WITH SENSOR
Route ORAL
Labeler Otsuka America Pharmaceutical, Inc.
Application NDA207202
Marketing category NDA
Marketing start 2018-01-31
Marketing end 0000-00-00
Substance ARIPIPRAZOLE
Active strength 10 mg/1
Pharmacologic classes Atypical Antipsychotic [EPC]
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 N207202-001 ABILIFY MYCITE KIT ARIPIPRAZOLE 2MG TABLET / ORAL RLD 2017-11-13 N207202-002 ABILIFY MYCITE KIT ARIPIPRAZOLE 5MG TABLET / ORAL RLD 2017-11-13 N207202-003 ABILIFY MYCITE KIT ARIPIPRAZOLE 10MG TABLET / ORAL RLD 2017-11-13 N207202-004 ABILIFY MYCITE KIT ARIPIPRAZOLE 15MG TABLET / ORAL RLD 2017-11-13 N207202-005 ABILIFY MYCITE KIT ARIPIPRAZOLE 20MG TABLET / ORAL RLD 2017-11-13 N207202-006 ABILIFY MYCITE KIT ARIPIPRAZOLE 30MG TABLET / ORAL RLD 2017-11-13
Orange Book patents# Current patent rows page 1 of 3 · 162 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 7 · 258 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 2026-09-14 22:38:34 2026-08 N207202-001 ABILIFY MYCITE KIT 2MG TABLET / ORAL RLD 2017-11-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207202-002 ABILIFY MYCITE KIT 5MG TABLET / ORAL RLD 2017-11-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207202-003 ABILIFY MYCITE KIT 10MG TABLET / ORAL RLD 2017-11-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207202-004 ABILIFY MYCITE KIT 15MG TABLET / ORAL RLD 2017-11-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207202-005 ABILIFY MYCITE KIT 20MG TABLET / ORAL RLD 2017-11-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207202-006 ABILIFY MYCITE KIT 30MG TABLET / ORAL RLD 2017-11-13 84e616aacf4f…2026-08-18 06:07:40 2026-07 N207202-001 ABILIFY MYCITE KIT 2MG TABLET / ORAL RLD 2017-11-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207202-002 ABILIFY MYCITE KIT 5MG TABLET / ORAL RLD 2017-11-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207202-003 ABILIFY MYCITE KIT 10MG TABLET / ORAL RLD 2017-11-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207202-004 ABILIFY MYCITE KIT 15MG TABLET / ORAL RLD 2017-11-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207202-005 ABILIFY MYCITE KIT 20MG TABLET / ORAL RLD 2017-11-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207202-006 ABILIFY MYCITE KIT 30MG TABLET / ORAL RLD 2017-11-13 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N207202-001 ABILIFY MYCITE KIT 2MG TABLET / ORAL RLD 2017-11-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207202-002 ABILIFY MYCITE KIT 5MG TABLET / ORAL RLD 2017-11-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207202-003 ABILIFY MYCITE KIT 10MG TABLET / ORAL RLD 2017-11-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207202-004 ABILIFY MYCITE KIT 15MG TABLET / ORAL RLD 2017-11-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207202-005 ABILIFY MYCITE KIT 20MG TABLET / ORAL RLD 2017-11-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207202-006 ABILIFY MYCITE KIT 30MG TABLET / ORAL RLD 2017-11-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207202-001 ABILIFY MYCITE KIT 2MG TABLET / ORAL RLD 2017-11-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207202-002 ABILIFY MYCITE KIT 5MG TABLET / ORAL RLD 2017-11-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207202-003 ABILIFY MYCITE KIT 10MG TABLET / ORAL RLD 2017-11-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207202-004 ABILIFY MYCITE KIT 15MG TABLET / ORAL RLD 2017-11-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207202-005 ABILIFY MYCITE KIT 20MG TABLET / ORAL RLD 2017-11-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207202-006 ABILIFY MYCITE KIT 30MG TABLET / ORAL RLD 2017-11-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N207202-001 ABILIFY MYCITE KIT 2MG TABLET / ORAL RLD 2017-11-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N207202-002 ABILIFY MYCITE KIT 5MG TABLET / ORAL RLD 2017-11-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N207202-003 ABILIFY MYCITE KIT 10MG TABLET / ORAL RLD 2017-11-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N207202-004 ABILIFY MYCITE KIT 15MG TABLET / ORAL RLD 2017-11-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N207202-005 ABILIFY MYCITE KIT 20MG TABLET / ORAL RLD 2017-11-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N207202-006 ABILIFY MYCITE KIT 30MG TABLET / ORAL RLD 2017-11-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N207202-001 ABILIFY MYCITE KIT 2MG TABLET / ORAL RLD 2017-11-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N207202-002 ABILIFY MYCITE KIT 5MG TABLET / ORAL RLD 2017-11-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N207202-003 ABILIFY MYCITE KIT 10MG TABLET / ORAL RLD 2017-11-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N207202-004 ABILIFY MYCITE KIT 15MG TABLET / ORAL RLD 2017-11-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N207202-005 ABILIFY MYCITE KIT 20MG TABLET / ORAL RLD 2017-11-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N207202-006 ABILIFY MYCITE KIT 30MG TABLET / ORAL RLD 2017-11-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N207202-001 ABILIFY MYCITE KIT 2MG TABLET / ORAL RLD 2017-11-13 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N207202-002 ABILIFY MYCITE KIT 5MG TABLET / ORAL RLD 2017-11-13 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N207202-003 ABILIFY MYCITE KIT 10MG TABLET / ORAL RLD 2017-11-13 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N207202-004 ABILIFY MYCITE KIT 15MG TABLET / ORAL RLD 2017-11-13 b8a1b40f171c…
Observed Orange Book patent history# Patent history page 1 of 197 · 7,854 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N207202-001 11476952 2026-04-28 Drug product 2022-11-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207202-001 9125939 2026-07-28 U-1749 2017-12-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207202-001 7978064 2026-09-14 Drug product 2017-12-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207202-001 8759350 2027-03-02 U-1529 2017-12-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207202-001 9444503 2027-11-19 U-2169 Drug product 2017-12-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207202-001 9119554 2028-12-16 Drug product 2017-12-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207202-001 9060708 2029-03-05 Drug product 2017-12-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207202-001 9258035 2029-03-05 Drug product 2017-12-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207202-001 8674825 2029-04-09 U-2170 Drug product 2017-12-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207202-001 8956288 2029-07-06 U-2167 Drug product 2017-12-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207202-001 10441194 2029-07-26 Drug product 2019-11-01 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207202-001 8945005 2029-08-19 U-2167 Drug product 2017-12-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207202-001 9433371 2029-09-15 Drug product 2017-12-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207202-001 8718193 2029-12-05 Drug product 2017-12-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207202-001 9149577 2029-12-15 Drug product 2017-12-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207202-001 8847766 2030-03-29 U-2167 Drug product 2017-12-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207202-001 8545402 2030-04-27 Drug product 2017-12-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207202-001 8114021 2030-06-21 Drug product 2017-12-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207202-001 11464423 2030-09-15 Drug product 2022-11-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207202-001 9941931 2030-11-04 Drug product 2018-05-07 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207202-001 8961412 2030-11-17 Drug product 2017-12-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207202-001 8258962 2030-11-25 Drug product 2017-12-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207202-001 8547248 2030-12-18 U-2167 Drug product 2017-12-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207202-001 11229378 2031-07-11 Drug product 2022-02-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207202-001 9320455 2031-12-15 Drug product 2017-12-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207202-001 10517507 2032-06-13 Drug product 2020-01-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207202-001 9268909 2033-10-15 U-2168 Drug product 2017-12-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207202-002 11476952 2026-04-28 Drug product 2022-11-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207202-002 9125939 2026-07-28 U-1749 2017-12-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207202-002 7978064 2026-09-14 Drug product 2017-12-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207202-002 8759350 2027-03-02 U-1529 2017-12-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207202-002 9444503 2027-11-19 U-2169 Drug product 2017-12-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207202-002 9119554 2028-12-16 Drug product 2017-12-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207202-002 9060708 2029-03-05 Drug product 2017-12-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207202-002 9258035 2029-03-05 Drug product 2017-12-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207202-002 8674825 2029-04-09 U-2170 Drug product 2017-12-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207202-002 8956288 2029-07-06 U-2167 Drug product 2017-12-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207202-002 10441194 2029-07-26 Drug product 2019-11-01 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207202-002 8945005 2029-08-19 U-2167 Drug product 2017-12-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207202-002 9433371 2029-09-15 Drug product 2017-12-12 84e616aacf4f…
Observed Orange Book exclusivity history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 59148-031-61 2021-08-02 These highlights do not include all the information needed to use ABILIFY MYCITE safely and effectively. See full prescribing information for ABILIFY MYCITE. ABILIFY MYCITE ® (aripiprazole tablets with sensor), for oral use Initial U.S. Approval: 2002 59148-031-72 2021-08-02 These highlights do not include all the information needed to use ABILIFY MYCITE safely and effectively. See full prescribing information for ABILIFY MYCITE. ABILIFY MYCITE ® (aripiprazole tablets with sensor), for oral use Initial U.S. Approval: 2002 59148-031-85 2021-08-02 These highlights do not include all the information needed to use ABILIFY MYCITE safely and effectively. See full prescribing information for ABILIFY MYCITE. ABILIFY MYCITE ® (aripiprazole tablets with sensor), for oral use Initial U.S. Approval: 2002 59148-031-90 2021-08-02 These highlights do not include all the information needed to use ABILIFY MYCITE safely and effectively. See full prescribing information for ABILIFY MYCITE. ABILIFY MYCITE ® (aripiprazole tablets with sensor), for oral use Initial U.S. Approval: 2002 59148-031-61 2021-07-23 These highlights do not include all the information needed to use ABILIFY MYCITE safely and effectively. See full prescribing information for ABILIFY MYCITE. ABILIFY MYCITE ® (aripiprazole tablets with sensor), for oral use Initial U.S. Approval: 2002 59148-031-72 2021-07-23 These highlights do not include all the information needed to use ABILIFY MYCITE safely and effectively. See full prescribing information for ABILIFY MYCITE. ABILIFY MYCITE ® (aripiprazole tablets with sensor), for oral use Initial U.S. Approval: 2002 59148-031-85 2021-07-23 These highlights do not include all the information needed to use ABILIFY MYCITE safely and effectively. See full prescribing information for ABILIFY MYCITE. ABILIFY MYCITE ® (aripiprazole tablets with sensor), for oral use Initial U.S. Approval: 2002 59148-031-90 2021-07-23 These highlights do not include all the information needed to use ABILIFY MYCITE safely and effectively. See full prescribing information for ABILIFY MYCITE. ABILIFY MYCITE ® (aripiprazole tablets with sensor), for oral use Initial U.S. Approval: 2002
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59148-031 ABILIFY MYCITE (ARIPIPRAZOLE) TABLET WITH SENSOR [OTSUKA AMERICA PHARMACEUTICAL, INC.] 16 Legacy NDC 20250202_e8787c3f-5e41-42d1-8091-44b56346620f.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 59148-031-72 59148003172 1 BOTTLE in 1 KIT (59148-031-72) > 30 TABLET WITH SENSOR in 1 BOTTLE (59148-031-13) 1 bottle 2020-12-19 0000-00-00 No No Current