Home NDC 55289-251 ABILIFY
Product NDC 55289-251
11-digit product format 552890251
Labeler code 55289
Product ID 55289-251_d9a5ad92-e821-2e62-e053-2995a90a2b59
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ARIPIPRAZOLE
Dosage form TABLET
Route ORAL
Labeler PD-Rx Pharmaceuticals, Inc.
Application NDA021436
Marketing category NDA
Marketing start 2002-11-15
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 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 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 55289-251-30 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 55289-251-30 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 55289-251-30 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 55289-251-30 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 55289-251-30 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 55289-251-30 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 55289-251-30 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 55289-251-30 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 55289-251-30 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 55289-251-30 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 55289-251-30 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 55289-251-30 557ba5c1ecfa…9c80585c8c6e…
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 N021436-001 ABILIFY ARIPIPRAZOLE 10MG TABLET / ORAL AB RLD, RS 2002-11-15 N021436-002 ABILIFY ARIPIPRAZOLE 15MG TABLET / ORAL AB RLD 2002-11-15 N021436-003 ABILIFY ARIPIPRAZOLE 20MG TABLET / ORAL AB RLD 2002-11-15 N021436-004 ABILIFY ARIPIPRAZOLE 30MG TABLET / ORAL AB RLD 2002-11-15 N021436-005 ABILIFY ARIPIPRAZOLE 5MG TABLET / ORAL AB RLD 2002-11-15 N021436-006 ABILIFY ARIPIPRAZOLE 2MG TABLET / ORAL AB RLD 2002-11-15
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 6 matching rows.
Orange Book patents# Current patent rows page 1 of 1 · 12 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 N021436-001 ABILIFY 10MG TABLET / ORAL AB RLD, RS 2002-11-15 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021436-002 ABILIFY 15MG TABLET / ORAL AB RLD 2002-11-15 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021436-003 ABILIFY 20MG TABLET / ORAL AB RLD 2002-11-15 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021436-004 ABILIFY 30MG TABLET / ORAL AB RLD 2002-11-15 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021436-005 ABILIFY 5MG TABLET / ORAL AB RLD 2002-11-15 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021436-006 ABILIFY 2MG TABLET / ORAL AB RLD 2002-11-15 84e616aacf4f…2026-08-18 06:07:40 2026-07 N021436-001 ABILIFY 10MG TABLET / ORAL AB RLD, RS 2002-11-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021436-002 ABILIFY 15MG TABLET / ORAL AB RLD 2002-11-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021436-003 ABILIFY 20MG TABLET / ORAL AB RLD 2002-11-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021436-004 ABILIFY 30MG TABLET / ORAL AB RLD 2002-11-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021436-005 ABILIFY 5MG TABLET / ORAL AB RLD 2002-11-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021436-006 ABILIFY 2MG TABLET / ORAL AB RLD 2002-11-15 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N021436-001 ABILIFY 10MG TABLET / ORAL AB RLD, RS 2002-11-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021436-002 ABILIFY 15MG TABLET / ORAL AB RLD 2002-11-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021436-003 ABILIFY 20MG TABLET / ORAL AB RLD 2002-11-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021436-004 ABILIFY 30MG TABLET / ORAL AB RLD 2002-11-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021436-005 ABILIFY 5MG TABLET / ORAL AB RLD 2002-11-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021436-006 ABILIFY 2MG TABLET / ORAL AB RLD 2002-11-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021436-001 ABILIFY 10MG TABLET / ORAL AB RLD, RS 2002-11-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021436-002 ABILIFY 15MG TABLET / ORAL AB RLD 2002-11-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021436-003 ABILIFY 20MG TABLET / ORAL AB RLD 2002-11-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021436-004 ABILIFY 30MG TABLET / ORAL AB RLD 2002-11-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021436-005 ABILIFY 5MG TABLET / ORAL AB RLD 2002-11-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021436-006 ABILIFY 2MG TABLET / ORAL AB RLD 2002-11-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021436-001 ABILIFY 10MG TABLET / ORAL AB RLD, RS 2002-11-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021436-002 ABILIFY 15MG TABLET / ORAL AB RLD 2002-11-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021436-003 ABILIFY 20MG TABLET / ORAL AB RLD 2002-11-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021436-004 ABILIFY 30MG TABLET / ORAL AB RLD 2002-11-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021436-005 ABILIFY 5MG TABLET / ORAL AB RLD 2002-11-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021436-006 ABILIFY 2MG TABLET / ORAL AB RLD 2002-11-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021436-001 ABILIFY 10MG TABLET / ORAL AB RLD, RS 2002-11-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021436-002 ABILIFY 15MG TABLET / ORAL AB RLD 2002-11-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021436-003 ABILIFY 20MG TABLET / ORAL AB RLD 2002-11-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021436-004 ABILIFY 30MG TABLET / ORAL AB RLD 2002-11-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021436-005 ABILIFY 5MG TABLET / ORAL AB RLD 2002-11-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021436-006 ABILIFY 2MG TABLET / ORAL AB RLD 2002-11-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021436-001 ABILIFY 10MG TABLET / ORAL AB RLD, RS 2002-11-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021436-002 ABILIFY 15MG TABLET / ORAL AB RLD 2002-11-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021436-003 ABILIFY 20MG TABLET / ORAL AB RLD 2002-11-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021436-004 ABILIFY 30MG TABLET / ORAL AB RLD 2002-11-15 b8a1b40f171c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 7 · 258 observed states.
Observed Orange Book patent history# Patent history page 1 of 54 · 2,124 observed states.
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 54 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ARIPIPRAZOLE ACTIVE INGREDIENT 82VFR53I78 ABILIFY (ARIPIPRAZOLE) TABLET [PD-RX PHARMACEUTICALS, INC.] 46 ARIPIPRAZOLE ACTIVE MOIETY 82VFR53I78 ABILIFY (ARIPIPRAZOLE) TABLET [PD-RX PHARMACEUTICALS, INC.] 46 ALUMINUM OXIDE INACTIVE INGREDIENT LMI26O6933 ABILIFY (ARIPIPRAZOLE) TABLET [PD-RX PHARMACEUTICALS, INC.] 46 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U ABILIFY (ARIPIPRAZOLE) TABLET [PD-RX PHARMACEUTICALS, INC.] 46 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK ABILIFY (ARIPIPRAZOLE) TABLET [PD-RX PHARMACEUTICALS, INC.] 46 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 ABILIFY (ARIPIPRAZOLE) TABLET [PD-RX PHARMACEUTICALS, INC.] 46 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT ABILIFY (ARIPIPRAZOLE) TABLET [PD-RX PHARMACEUTICALS, INC.] 46 HYDROXYPROPYL CELLULOSE INACTIVE INGREDIENT RFW2ET671P ABILIFY (ARIPIPRAZOLE) TABLET [PD-RX PHARMACEUTICALS, INC.] 46 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X ABILIFY (ARIPIPRAZOLE) TABLET [PD-RX PHARMACEUTICALS, INC.] 46 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 ABILIFY (ARIPIPRAZOLE) TABLET [PD-RX PHARMACEUTICALS, INC.] 46 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ ABILIFY (ARIPIPRAZOLE) TABLET [PD-RX PHARMACEUTICALS, INC.] 46
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 ABILIFY ARIPIPRAZOLE Otsuka America Pharmaceutical, Inc. c040bd1d-45b7-49f2-93ea-aed7220b30ac 2025-01-29 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 021436 application number: NDA021436
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 55289-251-30 55289025130 30 TABLET in 1 BOTTLE, PLASTIC (55289-251-30) 30 tablet 2011-02-17 0000-00-00 No No Current