Home NDC 16714-786 Aripiprazole
Product NDC 16714-786
11-digit product format 167140786
Labeler code 16714
Product ID 16714-786_7cc1f9b2-79b0-45d9-8559-834df504f5ca
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Aripiprazole
Dosage form TABLET
Route ORAL
Labeler NorthStar RxLLC
Application ANDA204111
Marketing category ANDA
Marketing start 2018-03-07
Marketing end 0000-00-00
Substance ARIPIPRAZOLE
Active strength 15 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 16714-786-01 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 16714-786-01 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 16714-786-01 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 16714-786-01 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 16714-786-01 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 16714-786-01 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 16714-786-01 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 16714-786-01 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 16714-786-01 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 16714-786-01 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 16714-786-01 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 16714-786-01 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 TE codes RLD / RS Approval date A204111-001 ARIPIPRAZOLE ARIPIPRAZOLE 2MG TABLET / ORAL AB 2016-10-07 A204111-002 ARIPIPRAZOLE ARIPIPRAZOLE 5MG TABLET / ORAL AB 2016-10-07 A204111-003 ARIPIPRAZOLE ARIPIPRAZOLE 10MG TABLET / ORAL AB 2016-10-07 A204111-004 ARIPIPRAZOLE ARIPIPRAZOLE 15MG TABLET / ORAL AB 2016-10-07 A204111-005 ARIPIPRAZOLE ARIPIPRAZOLE 20MG TABLET / ORAL AB 2016-10-07 A204111-006 ARIPIPRAZOLE ARIPIPRAZOLE 30MG TABLET / ORAL AB 2016-10-07
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 6 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 · 246 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 A204111-001 ARIPIPRAZOLE 2MG TABLET / ORAL AB 2016-10-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A204111-002 ARIPIPRAZOLE 5MG TABLET / ORAL AB 2016-10-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A204111-003 ARIPIPRAZOLE 10MG TABLET / ORAL AB 2016-10-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A204111-004 ARIPIPRAZOLE 15MG TABLET / ORAL AB 2016-10-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A204111-005 ARIPIPRAZOLE 20MG TABLET / ORAL AB 2016-10-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A204111-006 ARIPIPRAZOLE 30MG TABLET / ORAL AB 2016-10-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204111-001 ARIPIPRAZOLE 2MG TABLET / ORAL AB 2016-10-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204111-002 ARIPIPRAZOLE 5MG TABLET / ORAL AB 2016-10-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204111-003 ARIPIPRAZOLE 10MG TABLET / ORAL AB 2016-10-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204111-004 ARIPIPRAZOLE 15MG TABLET / ORAL AB 2016-10-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204111-005 ARIPIPRAZOLE 20MG TABLET / ORAL AB 2016-10-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204111-006 ARIPIPRAZOLE 30MG TABLET / ORAL AB 2016-10-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A204111-001 ARIPIPRAZOLE 2MG TABLET / ORAL AB 2016-10-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A204111-002 ARIPIPRAZOLE 5MG TABLET / ORAL AB 2016-10-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A204111-003 ARIPIPRAZOLE 10MG TABLET / ORAL AB 2016-10-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A204111-004 ARIPIPRAZOLE 15MG TABLET / ORAL AB 2016-10-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A204111-005 ARIPIPRAZOLE 20MG TABLET / ORAL AB 2016-10-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A204111-006 ARIPIPRAZOLE 30MG TABLET / ORAL AB 2016-10-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204111-001 ARIPIPRAZOLE 2MG TABLET / ORAL AB 2016-10-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204111-002 ARIPIPRAZOLE 5MG TABLET / ORAL AB 2016-10-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204111-003 ARIPIPRAZOLE 10MG TABLET / ORAL AB 2016-10-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204111-004 ARIPIPRAZOLE 15MG TABLET / ORAL AB 2016-10-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204111-005 ARIPIPRAZOLE 20MG TABLET / ORAL AB 2016-10-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204111-006 ARIPIPRAZOLE 30MG TABLET / ORAL AB 2016-10-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204111-001 ARIPIPRAZOLE 2MG TABLET / ORAL AB 2016-10-07 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204111-002 ARIPIPRAZOLE 5MG TABLET / ORAL AB 2016-10-07 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204111-003 ARIPIPRAZOLE 10MG TABLET / ORAL AB 2016-10-07 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204111-004 ARIPIPRAZOLE 15MG TABLET / ORAL AB 2016-10-07 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204111-005 ARIPIPRAZOLE 20MG TABLET / ORAL AB 2016-10-07 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204111-006 ARIPIPRAZOLE 30MG TABLET / ORAL AB 2016-10-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204111-001 ARIPIPRAZOLE 2MG TABLET / ORAL AB 2016-10-07 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204111-002 ARIPIPRAZOLE 5MG TABLET / ORAL AB 2016-10-07 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204111-003 ARIPIPRAZOLE 10MG TABLET / ORAL AB 2016-10-07 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204111-004 ARIPIPRAZOLE 15MG TABLET / ORAL AB 2016-10-07 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204111-005 ARIPIPRAZOLE 20MG TABLET / ORAL AB 2016-10-07 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204111-006 ARIPIPRAZOLE 30MG TABLET / ORAL AB 2016-10-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204111-001 ARIPIPRAZOLE 2MG TABLET / ORAL AB 2016-10-07 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204111-002 ARIPIPRAZOLE 5MG TABLET / ORAL AB 2016-10-07 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204111-003 ARIPIPRAZOLE 10MG TABLET / ORAL AB 2016-10-07 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204111-004 ARIPIPRAZOLE 15MG TABLET / ORAL AB 2016-10-07 2680178bc6a6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 7 · 246 observed states.
DailyMed Product Concepts# 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 Aripiprazole ARIPIPRAZOLE Macleods Pharmaceuticals Limited ab4245a1-71f7-45be-a2ef-b0636ed3cc20 2025-03-24 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 204111 application number: ANDA204111
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 16714-786-01 16714078601 30 TABLET in 1 BOTTLE (16714-786-01) 30 tablet 2018-03-07 0000-00-00 No No Current