Home NDC 43547-306 ARIPIPRAZOLE
Product NDC 43547-306
11-digit product format 435470306
Labeler code 43547
Product ID 43547-306_1f3b82ac-31e8-481a-adc5-dbfc29362ffd
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 2017-12-04
Substance ARIPIPRAZOLE
Active strength 20 mg/1
Pharmacologic classes Atypical Antipsychotic [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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 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 · 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 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…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205363-005 ARIPIPRAZOLE 20MG TABLET / ORAL AB 2017-12-04 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205363-006 ARIPIPRAZOLE 30MG TABLET / ORAL AB 2017-12-04 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205363-001 ARIPIPRAZOLE 2MG TABLET / ORAL AB 2017-12-04 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205363-002 ARIPIPRAZOLE 5MG TABLET / ORAL AB 2017-12-04 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205363-003 ARIPIPRAZOLE 10MG TABLET / ORAL AB 2017-12-04 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205363-004 ARIPIPRAZOLE 15MG TABLET / ORAL AB 2017-12-04 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205363-005 ARIPIPRAZOLE 20MG TABLET / ORAL AB 2017-12-04 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205363-006 ARIPIPRAZOLE 30MG TABLET / ORAL AB 2017-12-04 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205363-001 ARIPIPRAZOLE 2MG TABLET / ORAL AB 2017-12-04 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205363-002 ARIPIPRAZOLE 5MG TABLET / ORAL AB 2017-12-04 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205363-003 ARIPIPRAZOLE 10MG TABLET / ORAL AB 2017-12-04 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205363-004 ARIPIPRAZOLE 15MG TABLET / ORAL AB 2017-12-04 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 20 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 · 6 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 349490 Internal RxNorm lookup 349545 Internal RxNorm lookup 349547 Internal RxNorm lookup 349553 Internal RxNorm lookup 402131 Internal RxNorm lookup 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 43547-306-03 ARIPIPRAZOLE 30 in 1 BOTTLE TABLET 30 6 43547-306-09 ARIPIPRAZOLE 90 in 1 BOTTLE TABLET 90 6 43547-306-10 ARIPIPRAZOLE 100 in 1 BOTTLE TABLET 100 6 43547-306-50 ARIPIPRAZOLE 500 in 1 BOTTLE TABLET 500 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43547-306 ARIPIPRAZOLE TABLET [SOLCO HEALTHCARE U.S., LLC] 5 Current NDC, Legacy NDC, 4 package rows 20230411_686d0088-ac61-41df-8909-ae12f7957644.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 · 3 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join ARIPIPRAZOLE ARIPIPRAZOLE Solco Healthcare U.S., LLC abb8ad7e-7998-4485-a09f-a2892190f4ad 2024-04-23 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 205363 application number: ANDA205363 ARIPIPRAZOLE ARIPIPRAZOLE A-S Medication Solutions db6fc74e-4989-464d-9c19-a5b7a541fd46 2024-03-10 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 205363 application number: ANDA205363 ARIPIPRAZOLE ARIPIPRAZOLE Solco Healthcare U.S., LLC 686d0088-ac61-41df-8909-ae12f7957644 2023-04-18 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 205363 application number: ANDA205363 ndc (product): 43547-306
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 43547-306-03 43547030603 30 TABLET in 1 BOTTLE (43547-306-03) 30 tablet 2017-12-04 0000-00-00 No No Current 43547-306-09 43547030609 90 TABLET in 1 BOTTLE (43547-306-09) 90 tablet 2017-12-04 0000-00-00 No No Current 43547-306-10 43547030610 100 TABLET in 1 BOTTLE (43547-306-10) 100 tablet 2017-12-04 0000-00-00 No No Current 43547-306-50 43547030650 500 TABLET in 1 BOTTLE (43547-306-50) 500 tablet 2017-12-04 0000-00-00 No No Current