Home NDC 43547-889 ARIPIPRAZOLE
Product NDC 43547-889
11-digit product format 435470889
Labeler code 43547
Product ID 43547-889_870d46f9-1c53-467f-8a8e-f72285f16d08
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name aripiprazole
Dosage form TABLET
Route ORAL
Labeler Solco Healthcare U.S., LLC
Application ANDA205363
Marketing category ANDA
Marketing start 2017-09-15
Substance ARIPIPRAZOLE
Active strength 30 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 43 .
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 A205363-001 ARIPIPRAZOLE ARIPIPRAZOLE 2MG TABLET / ORAL AB 2017-12-04 A205363-002 ARIPIPRAZOLE ARIPIPRAZOLE 5MG TABLET / ORAL AB 2017-12-04 A205363-003 ARIPIPRAZOLE ARIPIPRAZOLE 10MG TABLET / ORAL AB 2017-12-04 A205363-004 ARIPIPRAZOLE ARIPIPRAZOLE 15MG TABLET / ORAL AB 2017-12-04 A205363-005 ARIPIPRAZOLE ARIPIPRAZOLE 20MG TABLET / ORAL AB 2017-12-04 A205363-006 ARIPIPRAZOLE ARIPIPRAZOLE 30MG TABLET / ORAL AB 2017-12-04
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 · 258 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 2026-09-14 22:38:34 2026-08 A205363-001 ARIPIPRAZOLE 2MG TABLET / ORAL AB 2017-12-04 84e616aacf4f…2026-09-14 22:38:34 2026-08 A205363-002 ARIPIPRAZOLE 5MG TABLET / ORAL AB 2017-12-04 84e616aacf4f…2026-09-14 22:38:34 2026-08 A205363-003 ARIPIPRAZOLE 10MG TABLET / ORAL AB 2017-12-04 84e616aacf4f…2026-09-14 22:38:34 2026-08 A205363-004 ARIPIPRAZOLE 15MG TABLET / ORAL AB 2017-12-04 84e616aacf4f…2026-09-14 22:38:34 2026-08 A205363-005 ARIPIPRAZOLE 20MG TABLET / ORAL AB 2017-12-04 84e616aacf4f…2026-09-14 22:38:34 2026-08 A205363-006 ARIPIPRAZOLE 30MG TABLET / ORAL AB 2017-12-04 84e616aacf4f…2026-08-18 06:07:40 2026-07 A205363-001 ARIPIPRAZOLE 2MG TABLET / ORAL AB 2017-12-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A205363-002 ARIPIPRAZOLE 5MG TABLET / ORAL AB 2017-12-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A205363-003 ARIPIPRAZOLE 10MG TABLET / ORAL AB 2017-12-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A205363-004 ARIPIPRAZOLE 15MG TABLET / ORAL AB 2017-12-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A205363-005 ARIPIPRAZOLE 20MG TABLET / ORAL AB 2017-12-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A205363-006 ARIPIPRAZOLE 30MG TABLET / ORAL AB 2017-12-04 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A205363-001 ARIPIPRAZOLE 2MG TABLET / ORAL AB 2017-12-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A205363-002 ARIPIPRAZOLE 5MG TABLET / ORAL AB 2017-12-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A205363-003 ARIPIPRAZOLE 10MG TABLET / ORAL AB 2017-12-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A205363-004 ARIPIPRAZOLE 15MG TABLET / ORAL AB 2017-12-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A205363-005 ARIPIPRAZOLE 20MG TABLET / ORAL AB 2017-12-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A205363-006 ARIPIPRAZOLE 30MG TABLET / ORAL AB 2017-12-04 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205363-001 ARIPIPRAZOLE 2MG TABLET / ORAL AB 2017-12-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205363-002 ARIPIPRAZOLE 5MG TABLET / ORAL AB 2017-12-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205363-003 ARIPIPRAZOLE 10MG TABLET / ORAL AB 2017-12-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205363-004 ARIPIPRAZOLE 15MG TABLET / ORAL AB 2017-12-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205363-005 ARIPIPRAZOLE 20MG TABLET / ORAL AB 2017-12-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205363-006 ARIPIPRAZOLE 30MG TABLET / ORAL AB 2017-12-04 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A205363-001 ARIPIPRAZOLE 2MG TABLET / ORAL AB 2017-12-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A205363-002 ARIPIPRAZOLE 5MG TABLET / ORAL AB 2017-12-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A205363-003 ARIPIPRAZOLE 10MG TABLET / ORAL AB 2017-12-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A205363-004 ARIPIPRAZOLE 15MG TABLET / ORAL AB 2017-12-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A205363-005 ARIPIPRAZOLE 20MG TABLET / ORAL AB 2017-12-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A205363-006 ARIPIPRAZOLE 30MG TABLET / ORAL AB 2017-12-04 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205363-001 ARIPIPRAZOLE 2MG TABLET / ORAL AB 2017-12-04 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205363-002 ARIPIPRAZOLE 5MG TABLET / ORAL AB 2017-12-04 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205363-003 ARIPIPRAZOLE 10MG TABLET / ORAL AB 2017-12-04 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205363-004 ARIPIPRAZOLE 15MG TABLET / ORAL AB 2017-12-04 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205363-005 ARIPIPRAZOLE 20MG TABLET / ORAL AB 2017-12-04 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205363-006 ARIPIPRAZOLE 30MG TABLET / ORAL AB 2017-12-04 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205363-001 ARIPIPRAZOLE 2MG TABLET / ORAL AB 2017-12-04 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205363-002 ARIPIPRAZOLE 5MG TABLET / ORAL AB 2017-12-04 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205363-003 ARIPIPRAZOLE 10MG TABLET / ORAL AB 2017-12-04 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205363-004 ARIPIPRAZOLE 15MG TABLET / ORAL AB 2017-12-04 b8a1b40f171c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 7 · 258 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 30 mg/1
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 43547-889-03 ARIPIPRAZOLE 30 in 1 BOTTLE TABLET 30 1 43547-889-50 ARIPIPRAZOLE 500 in 1 BOTTLE TABLET 500 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43547-889 ARIPIPRAZOLE TABLET [SOLCO HEALTHCARE U.S., LLC] 1 Current NDC, 2 package rows 20250121_abb8ad7e-7998-4485-a09f-a2892190f4ad.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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 43547-889-03 43547088903 30 TABLET in 1 BOTTLE (43547-889-03) 30 tablet 2017-12-04 No No Current 43547-889-50 43547088950 500 TABLET in 1 BOTTLE (43547-889-50) 500 tablet 2017-12-04 No No Current