Home NDC 63629-7774 Aripiprazole
Product NDC 63629-7774
11-digit product format 636297774
Labeler code 63629
Product ID 63629-7774_392861a2-8af9-4918-ba39-00e68ca3bb3f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Aripiprazole
Dosage form TABLET
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA204838
Marketing category ANDA
Marketing start 2016-06-20
Substance ARIPIPRAZOLE
Active strength 30 mg/1
Pharmacologic classes Atypical Antipsychotic [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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 · 6 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 2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 63629-7774-1 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 63629-7774-1 1332a3947898…d4bfe170f9cd…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 63629-7774-1 9bebd1f3094a…5416666fcb17…
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 A204838-001 ARIPIPRAZOLE ARIPIPRAZOLE 2MG TABLET / ORAL AB 2016-06-17 A204838-002 ARIPIPRAZOLE ARIPIPRAZOLE 5MG TABLET / ORAL AB 2016-06-17 A204838-003 ARIPIPRAZOLE ARIPIPRAZOLE 10MG TABLET / ORAL AB 2016-06-17 A204838-004 ARIPIPRAZOLE ARIPIPRAZOLE 15MG TABLET / ORAL AB 2016-06-17 A204838-005 ARIPIPRAZOLE ARIPIPRAZOLE 20MG TABLET / ORAL AB 2016-06-17 A204838-006 ARIPIPRAZOLE ARIPIPRAZOLE 30MG TABLET / ORAL AB 2016-06-17
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 A204838-001 ARIPIPRAZOLE 2MG TABLET / ORAL AB 2016-06-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A204838-002 ARIPIPRAZOLE 5MG TABLET / ORAL AB 2016-06-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A204838-003 ARIPIPRAZOLE 10MG TABLET / ORAL AB 2016-06-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A204838-004 ARIPIPRAZOLE 15MG TABLET / ORAL AB 2016-06-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A204838-005 ARIPIPRAZOLE 20MG TABLET / ORAL AB 2016-06-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A204838-006 ARIPIPRAZOLE 30MG TABLET / ORAL AB 2016-06-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204838-001 ARIPIPRAZOLE 2MG TABLET / ORAL AB 2016-06-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204838-002 ARIPIPRAZOLE 5MG TABLET / ORAL AB 2016-06-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204838-003 ARIPIPRAZOLE 10MG TABLET / ORAL AB 2016-06-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204838-004 ARIPIPRAZOLE 15MG TABLET / ORAL AB 2016-06-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204838-005 ARIPIPRAZOLE 20MG TABLET / ORAL AB 2016-06-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204838-006 ARIPIPRAZOLE 30MG TABLET / ORAL AB 2016-06-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A204838-001 ARIPIPRAZOLE 2MG TABLET / ORAL AB 2016-06-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A204838-002 ARIPIPRAZOLE 5MG TABLET / ORAL AB 2016-06-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A204838-003 ARIPIPRAZOLE 10MG TABLET / ORAL AB 2016-06-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A204838-004 ARIPIPRAZOLE 15MG TABLET / ORAL AB 2016-06-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A204838-005 ARIPIPRAZOLE 20MG TABLET / ORAL AB 2016-06-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A204838-006 ARIPIPRAZOLE 30MG TABLET / ORAL AB 2016-06-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204838-001 ARIPIPRAZOLE 2MG TABLET / ORAL AB 2016-06-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204838-002 ARIPIPRAZOLE 5MG TABLET / ORAL AB 2016-06-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204838-003 ARIPIPRAZOLE 10MG TABLET / ORAL AB 2016-06-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204838-004 ARIPIPRAZOLE 15MG TABLET / ORAL AB 2016-06-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204838-005 ARIPIPRAZOLE 20MG TABLET / ORAL AB 2016-06-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204838-006 ARIPIPRAZOLE 30MG TABLET / ORAL AB 2016-06-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204838-001 ARIPIPRAZOLE 2MG TABLET / ORAL AB 2016-06-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204838-002 ARIPIPRAZOLE 5MG TABLET / ORAL AB 2016-06-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204838-003 ARIPIPRAZOLE 10MG TABLET / ORAL AB 2016-06-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204838-004 ARIPIPRAZOLE 15MG TABLET / ORAL AB 2016-06-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204838-005 ARIPIPRAZOLE 20MG TABLET / ORAL AB 2016-06-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204838-006 ARIPIPRAZOLE 30MG TABLET / ORAL AB 2016-06-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204838-001 ARIPIPRAZOLE 2MG TABLET / ORAL AB 2016-06-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204838-002 ARIPIPRAZOLE 5MG TABLET / ORAL AB 2016-06-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204838-003 ARIPIPRAZOLE 10MG TABLET / ORAL AB 2016-06-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204838-004 ARIPIPRAZOLE 15MG TABLET / ORAL AB 2016-06-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204838-005 ARIPIPRAZOLE 20MG TABLET / ORAL AB 2016-06-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204838-006 ARIPIPRAZOLE 30MG TABLET / ORAL AB 2016-06-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204838-001 ARIPIPRAZOLE 2MG TABLET / ORAL AB 2016-06-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204838-002 ARIPIPRAZOLE 5MG TABLET / ORAL AB 2016-06-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204838-003 ARIPIPRAZOLE 10MG TABLET / ORAL AB 2016-06-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204838-004 ARIPIPRAZOLE 15MG TABLET / ORAL AB 2016-06-17 2680178bc6a6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 7 · 246 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Aripiprazole
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ARIPIPRAZOLE 30 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 82VFR53I78 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 349547 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 63629-7774-1 Aripiprazole 30 in 1 BOTTLE TABLET 30 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63629-7774 ARIPIPRAZOLE TABLET [BRYANT RANCH PREPACK] 6 Current NDC, Legacy NDC, 1 package rows 20240516_96172aa4-9e13-4eca-83d5-85a88c1782d3.zip
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 · 5 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Aripiprazole ARIPIPRAZOLE REMEDYREPACK INC. a1191a90-eb83-4a59-948c-b9774d2c83a5 2026-07-02 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 204838 application number: ANDA204838 Aripiprazole ARIPIPRAZOLE Major Pharmaceuticals 573c6bb6-941f-4413-8c23-826025385864 2026-05-21 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 204838 application number: ANDA204838 Aripiprazole ARIPIPRAZOLE Amneal Pharmaceuticals LLC 06dda03f-8481-46d6-af02-4f51e1a3a065 2025-02-20 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 204838 application number: ANDA204838 Aripiprazole ARIPIPRAZOLE Bryant Ranch Prepack 96172aa4-9e13-4eca-83d5-85a88c1782d3 2024-04-03 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 204838 application number: ANDA204838 ndc (product): 63629-7774 Aripiprazole ARIPIPRAZOLE Proficient Rx LP dbdc8fbe-c75f-4f17-a2cd-9f23802dcc5d 2019-11-01 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 204838 application number: ANDA204838
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 63629-7774-1 63629777401 30 TABLET in 1 BOTTLE (63629-7774-1) 30 tablet 2018-07-03 0000-00-00 No No Current