Home NDC 63187-965 Aripiprazole
Product NDC 63187-965
11-digit product format 631870965
Labeler code 63187
Product ID 63187-965_3f575cc4-f92e-4e55-aeb2-c634fe3411d3
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Aripiprazole
Dosage form TABLET
Route ORAL
Labeler Proficient Rx LP
Application ANDA204838
Marketing category ANDA
Marketing start 2016-06-20
Substance ARIPIPRAZOLE
Active strength 2 mg/1
Pharmacologic classes Atypical Antipsychotic [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 · 264 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 2026-10-15 13:18:30 2026-09 A204838-001 ARIPIPRAZOLE 2MG TABLET / ORAL AB 2016-06-17 c2088c7a36db…2026-10-15 13:18:30 2026-09 A204838-002 ARIPIPRAZOLE 5MG TABLET / ORAL AB 2016-06-17 c2088c7a36db…2026-10-15 13:18:30 2026-09 A204838-003 ARIPIPRAZOLE 10MG TABLET / ORAL AB 2016-06-17 c2088c7a36db…2026-10-15 13:18:30 2026-09 A204838-004 ARIPIPRAZOLE 15MG TABLET / ORAL AB 2016-06-17 c2088c7a36db…2026-10-15 13:18:30 2026-09 A204838-005 ARIPIPRAZOLE 20MG TABLET / ORAL AB 2016-06-17 c2088c7a36db…2026-10-15 13:18:30 2026-09 A204838-006 ARIPIPRAZOLE 30MG TABLET / ORAL AB 2016-06-17 c2088c7a36db…2026-09-14 22:38:34 2026-08 A204838-001 ARIPIPRAZOLE 2MG TABLET / ORAL AB 2016-06-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 A204838-002 ARIPIPRAZOLE 5MG TABLET / ORAL AB 2016-06-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 A204838-003 ARIPIPRAZOLE 10MG TABLET / ORAL AB 2016-06-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 A204838-004 ARIPIPRAZOLE 15MG TABLET / ORAL AB 2016-06-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 A204838-005 ARIPIPRAZOLE 20MG TABLET / ORAL AB 2016-06-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 A204838-006 ARIPIPRAZOLE 30MG TABLET / ORAL AB 2016-06-17 84e616aacf4f…2026-08-18 06:07:40 2026-07 A204838-001 ARIPIPRAZOLE 2MG TABLET / ORAL AB 2016-06-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A204838-002 ARIPIPRAZOLE 5MG TABLET / ORAL AB 2016-06-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A204838-003 ARIPIPRAZOLE 10MG TABLET / ORAL AB 2016-06-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A204838-004 ARIPIPRAZOLE 15MG TABLET / ORAL AB 2016-06-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A204838-005 ARIPIPRAZOLE 20MG TABLET / ORAL AB 2016-06-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A204838-006 ARIPIPRAZOLE 30MG TABLET / ORAL AB 2016-06-17 caaa826d4ba7…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…
Observed Orange Book normalized TE history# Normalized TE history page 2 of 7 · 264 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Aripiprazole
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ARIPIPRAZOLE 2 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 602964 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 63187-965-30 Aripiprazole 30 in 1 BOTTLE TABLET 30 3 63187-965-60 Aripiprazole 60 in 1 BOTTLE TABLET 60 3 63187-965-90 Aripiprazole 90 in 1 BOTTLE TABLET 90 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63187-965 ARIPIPRAZOLE TABLET [PROFICIENT RX LP] 3 Current NDC, Legacy NDC, 3 package rows 20191105_dbdc8fbe-c75f-4f17-a2cd-9f23802dcc5d.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 · 4 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 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 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 ndc (product): 63187-965
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 63187-965-30 63187096530 30 TABLET in 1 BOTTLE (63187-965-30) 30 tablet 2018-01-01 0000-00-00 No No Current 63187-965-60 63187096560 60 TABLET in 1 BOTTLE (63187-965-60) 60 tablet 2018-01-01 0000-00-00 No No Current 63187-965-90 63187096590 90 TABLET in 1 BOTTLE (63187-965-90) 90 tablet 2018-01-01 0000-00-00 No No Current