Home NDC 64725-8000 ABILIFY
Product NDC 64725-8000
11-digit product format 647258000
Labeler code 64725
Product ID 64725-8000_86ddf799-88d3-4d05-ae29-34e13a89cd22
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ARIPIPRAZOLE
Dosage form TABLET
Route ORAL
Labeler TYA Pharmaceuticals
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 E
Listing certified through 2017-12-31
Current FDA listing Historical FDA.report record 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 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.
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 2026-08-01 22:54:32 2026-06 N021436-001 ABILIFY 10MG TABLET / ORAL AB RLD, RS 2002-11-15 a50c72e98297…2026-08-01 22:54:32 2026-06 N021436-002 ABILIFY 15MG TABLET / ORAL AB RLD 2002-11-15 a50c72e98297…2026-08-01 22:54:32 2026-06 N021436-003 ABILIFY 20MG TABLET / ORAL AB RLD 2002-11-15 a50c72e98297…2026-08-01 22:54:32 2026-06 N021436-004 ABILIFY 30MG TABLET / ORAL AB RLD 2002-11-15 a50c72e98297…2026-08-01 22:54:32 2026-06 N021436-005 ABILIFY 5MG TABLET / ORAL AB RLD 2002-11-15 a50c72e98297…2026-08-01 22:54:32 2026-06 N021436-006 ABILIFY 2MG TABLET / ORAL AB RLD 2002-11-15 a50c72e98297…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-01 22:54:32 2026-06 N021436-001 9125939 2026-07-28 U-1749 2015-10-07 a50c72e98297…2026-08-01 22:54:32 2026-06 N021436-001 8759350 2027-03-02 U-1529 2014-07-22 a50c72e98297…2026-08-01 22:54:32 2026-06 N021436-002 9125939 2026-07-28 U-1749 2015-10-07 a50c72e98297…2026-08-01 22:54:32 2026-06 N021436-002 8759350 2027-03-02 U-1529 2014-07-22 a50c72e98297…2026-08-01 22:54:32 2026-06 N021436-003 9125939 2026-07-28 U-1749 2015-10-07 a50c72e98297…2026-08-01 22:54:32 2026-06 N021436-003 8759350 2027-03-02 U-1529 2014-07-22 a50c72e98297…2026-08-01 22:54:32 2026-06 N021436-004 9125939 2026-07-28 U-1749 2015-10-07 a50c72e98297…2026-08-01 22:54:32 2026-06 N021436-004 8759350 2027-03-02 U-1529 2014-07-22 a50c72e98297…2026-08-01 22:54:32 2026-06 N021436-005 9125939 2026-07-28 U-1749 2015-10-07 a50c72e98297…2026-08-01 22:54:32 2026-06 N021436-005 8759350 2027-03-02 U-1529 2014-07-22 a50c72e98297…2026-08-01 22:54:32 2026-06 N021436-006 9125939 2026-07-28 U-1749 2015-10-07 a50c72e98297…2026-08-01 22:54:32 2026-06 N021436-006 8759350 2027-03-02 U-1529 2014-07-22 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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
FDA-Initiated Inactive NDC Indexing#