Home NDC 60505-2673-8 Aripiprazole
Product NDC 60505-2673
Requested package NDC 60505-2673-8
11-digit product format 605052673
Labeler code 60505
Product ID 60505-2673_2a711e92-f48e-998e-f328-449ccf7d0dcf
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Aripiprazole
Dosage form TABLET
Route ORAL
Labeler Apotex Corp
Application ANDA078583
Marketing category ANDA
Marketing start 2015-07-24
Marketing end 0000-00-00
Substance ARIPIPRAZOLE
Active strength 5 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 · 9 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…
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 A078583-001 ARIPIPRAZOLE ARIPIPRAZOLE 2MG TABLET / ORAL 2015-07-24 A078583-002 ARIPIPRAZOLE ARIPIPRAZOLE 5MG TABLET / ORAL 2015-07-24 A078583-003 ARIPIPRAZOLE ARIPIPRAZOLE 10MG TABLET / ORAL 2015-07-24 A078583-004 ARIPIPRAZOLE ARIPIPRAZOLE 15MG TABLET / ORAL 2015-07-24 A078583-005 ARIPIPRAZOLE ARIPIPRAZOLE 20MG TABLET / ORAL 2015-07-24 A078583-006 ARIPIPRAZOLE ARIPIPRAZOLE 30MG TABLET / ORAL 2015-07-24
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 A078583-001 ARIPIPRAZOLE 2MG TABLET / ORAL AB 2015-07-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078583-002 ARIPIPRAZOLE 5MG TABLET / ORAL AB 2015-07-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078583-003 ARIPIPRAZOLE 10MG TABLET / ORAL AB 2015-07-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078583-004 ARIPIPRAZOLE 15MG TABLET / ORAL AB 2015-07-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078583-005 ARIPIPRAZOLE 20MG TABLET / ORAL AB 2015-07-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078583-006 ARIPIPRAZOLE 30MG TABLET / ORAL AB 2015-07-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078583-001 ARIPIPRAZOLE 2MG TABLET / ORAL AB 2015-07-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078583-002 ARIPIPRAZOLE 5MG TABLET / ORAL AB 2015-07-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078583-003 ARIPIPRAZOLE 10MG TABLET / ORAL AB 2015-07-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078583-004 ARIPIPRAZOLE 15MG TABLET / ORAL AB 2015-07-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078583-005 ARIPIPRAZOLE 20MG TABLET / ORAL AB 2015-07-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078583-006 ARIPIPRAZOLE 30MG TABLET / ORAL AB 2015-07-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078583-001 ARIPIPRAZOLE 2MG TABLET / ORAL AB 2015-07-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078583-002 ARIPIPRAZOLE 5MG TABLET / ORAL AB 2015-07-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078583-003 ARIPIPRAZOLE 10MG TABLET / ORAL AB 2015-07-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078583-004 ARIPIPRAZOLE 15MG TABLET / ORAL AB 2015-07-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078583-005 ARIPIPRAZOLE 20MG TABLET / ORAL AB 2015-07-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078583-006 ARIPIPRAZOLE 30MG TABLET / ORAL AB 2015-07-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078583-001 ARIPIPRAZOLE 2MG TABLET / ORAL AB 2015-07-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078583-002 ARIPIPRAZOLE 5MG TABLET / ORAL AB 2015-07-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078583-003 ARIPIPRAZOLE 10MG TABLET / ORAL AB 2015-07-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078583-004 ARIPIPRAZOLE 15MG TABLET / ORAL AB 2015-07-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078583-005 ARIPIPRAZOLE 20MG TABLET / ORAL AB 2015-07-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078583-006 ARIPIPRAZOLE 30MG TABLET / ORAL AB 2015-07-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078583-001 ARIPIPRAZOLE 2MG TABLET / ORAL AB 2015-07-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078583-002 ARIPIPRAZOLE 5MG TABLET / ORAL AB 2015-07-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078583-003 ARIPIPRAZOLE 10MG TABLET / ORAL AB 2015-07-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078583-004 ARIPIPRAZOLE 15MG TABLET / ORAL AB 2015-07-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078583-005 ARIPIPRAZOLE 20MG TABLET / ORAL AB 2015-07-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078583-006 ARIPIPRAZOLE 30MG TABLET / ORAL AB 2015-07-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078583-001 ARIPIPRAZOLE 2MG TABLET / ORAL AB 2015-07-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078583-002 ARIPIPRAZOLE 5MG TABLET / ORAL AB 2015-07-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078583-003 ARIPIPRAZOLE 10MG TABLET / ORAL AB 2015-07-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078583-004 ARIPIPRAZOLE 15MG TABLET / ORAL AB 2015-07-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078583-005 ARIPIPRAZOLE 20MG TABLET / ORAL AB 2015-07-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078583-006 ARIPIPRAZOLE 30MG TABLET / ORAL AB 2015-07-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078583-001 ARIPIPRAZOLE 2MG TABLET / ORAL AB 2015-07-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078583-002 ARIPIPRAZOLE 5MG TABLET / ORAL AB 2015-07-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078583-003 ARIPIPRAZOLE 10MG TABLET / ORAL AB 2015-07-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078583-004 ARIPIPRAZOLE 15MG TABLET / ORAL AB 2015-07-24 2680178bc6a6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 6 · 240 observed states.
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 60505-2673 ARIPIPRAZOLE TABLET [APOTEX CORP] 18 Legacy NDC 20250321_569f1c32-fb6f-c34f-0894-4b1e7b744a8a.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 60505-2673-8 60505267308 1000 TABLET in 1 BOTTLE (60505-2673-8) 1000 tablet 2015-07-24 0000-00-00 No No Current