Home NDC 33342-122 Aripiprazole
Product NDC 33342-122
11-digit product format 333420122
Labeler code 33342
Product ID 33342-122_deb9183f-bf62-4547-9c33-b6d8af55ddd9
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Aripiprazole
Dosage form TABLET
Route ORAL
Labeler Macleods Pharmaceuticals Limited
Application ANDA204111
Marketing category ANDA
Marketing start 2016-10-08
Substance ARIPIPRAZOLE
Active strength 2 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 A204111-001 ARIPIPRAZOLE ARIPIPRAZOLE 2MG TABLET / ORAL AB 2016-10-07 A204111-002 ARIPIPRAZOLE ARIPIPRAZOLE 5MG TABLET / ORAL AB 2016-10-07 A204111-003 ARIPIPRAZOLE ARIPIPRAZOLE 10MG TABLET / ORAL AB 2016-10-07 A204111-004 ARIPIPRAZOLE ARIPIPRAZOLE 15MG TABLET / ORAL AB 2016-10-07 A204111-005 ARIPIPRAZOLE ARIPIPRAZOLE 20MG TABLET / ORAL AB 2016-10-07 A204111-006 ARIPIPRAZOLE ARIPIPRAZOLE 30MG TABLET / ORAL AB 2016-10-07
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 A204111-001 ARIPIPRAZOLE 2MG TABLET / ORAL AB 2016-10-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A204111-002 ARIPIPRAZOLE 5MG TABLET / ORAL AB 2016-10-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A204111-003 ARIPIPRAZOLE 10MG TABLET / ORAL AB 2016-10-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A204111-004 ARIPIPRAZOLE 15MG TABLET / ORAL AB 2016-10-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A204111-005 ARIPIPRAZOLE 20MG TABLET / ORAL AB 2016-10-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A204111-006 ARIPIPRAZOLE 30MG TABLET / ORAL AB 2016-10-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204111-001 ARIPIPRAZOLE 2MG TABLET / ORAL AB 2016-10-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204111-002 ARIPIPRAZOLE 5MG TABLET / ORAL AB 2016-10-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204111-003 ARIPIPRAZOLE 10MG TABLET / ORAL AB 2016-10-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204111-004 ARIPIPRAZOLE 15MG TABLET / ORAL AB 2016-10-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204111-005 ARIPIPRAZOLE 20MG TABLET / ORAL AB 2016-10-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204111-006 ARIPIPRAZOLE 30MG TABLET / ORAL AB 2016-10-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A204111-001 ARIPIPRAZOLE 2MG TABLET / ORAL AB 2016-10-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A204111-002 ARIPIPRAZOLE 5MG TABLET / ORAL AB 2016-10-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A204111-003 ARIPIPRAZOLE 10MG TABLET / ORAL AB 2016-10-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A204111-004 ARIPIPRAZOLE 15MG TABLET / ORAL AB 2016-10-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A204111-005 ARIPIPRAZOLE 20MG TABLET / ORAL AB 2016-10-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A204111-006 ARIPIPRAZOLE 30MG TABLET / ORAL AB 2016-10-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204111-001 ARIPIPRAZOLE 2MG TABLET / ORAL AB 2016-10-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204111-002 ARIPIPRAZOLE 5MG TABLET / ORAL AB 2016-10-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204111-003 ARIPIPRAZOLE 10MG TABLET / ORAL AB 2016-10-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204111-004 ARIPIPRAZOLE 15MG TABLET / ORAL AB 2016-10-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204111-005 ARIPIPRAZOLE 20MG TABLET / ORAL AB 2016-10-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204111-006 ARIPIPRAZOLE 30MG TABLET / ORAL AB 2016-10-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204111-001 ARIPIPRAZOLE 2MG TABLET / ORAL AB 2016-10-07 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204111-002 ARIPIPRAZOLE 5MG TABLET / ORAL AB 2016-10-07 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204111-003 ARIPIPRAZOLE 10MG TABLET / ORAL AB 2016-10-07 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204111-004 ARIPIPRAZOLE 15MG TABLET / ORAL AB 2016-10-07 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204111-005 ARIPIPRAZOLE 20MG TABLET / ORAL AB 2016-10-07 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204111-006 ARIPIPRAZOLE 30MG TABLET / ORAL AB 2016-10-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204111-001 ARIPIPRAZOLE 2MG TABLET / ORAL AB 2016-10-07 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204111-002 ARIPIPRAZOLE 5MG TABLET / ORAL AB 2016-10-07 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204111-003 ARIPIPRAZOLE 10MG TABLET / ORAL AB 2016-10-07 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204111-004 ARIPIPRAZOLE 15MG TABLET / ORAL AB 2016-10-07 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204111-005 ARIPIPRAZOLE 20MG TABLET / ORAL AB 2016-10-07 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204111-006 ARIPIPRAZOLE 30MG TABLET / ORAL AB 2016-10-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204111-001 ARIPIPRAZOLE 2MG TABLET / ORAL AB 2016-10-07 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204111-002 ARIPIPRAZOLE 5MG TABLET / ORAL AB 2016-10-07 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204111-003 ARIPIPRAZOLE 10MG TABLET / ORAL AB 2016-10-07 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204111-004 ARIPIPRAZOLE 15MG TABLET / ORAL AB 2016-10-07 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 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 · 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 33342-122-07 Aripiprazole 30 in 1 BOTTLE TABLET 30 9 33342-122-11 Aripiprazole 100 in 1 BOTTLE TABLET 100 9 33342-122-12 Aripiprazole 10 in 1 CARTON TABLET 10 9 33342-122-12 Aripiprazole 10 in 1 BLISTER PACK TABLET 10 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 33342-122 ARIPIPRAZOLE TABLET [MACLEODS PHARMACEUTICALS LIMITED] 9 Current NDC, Legacy NDC, 4 package rows 20250327_ab4245a1-71f7-45be-a2ef-b0636ed3cc20.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 · 1 matching rows.
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 33342-122-07 33342012207 30 TABLET in 1 BOTTLE (33342-122-07) 30 tablet 2016-10-08 0000-00-00 No No Current 33342-122-11 33342012211 100 TABLET in 1 BOTTLE (33342-122-11) 100 tablet 2016-10-08 0000-00-00 No No Current 33342-122-12 33342012212 10 BLISTER PACK in 1 CARTON (33342-122-12) / 10 TABLET in 1 BLISTER PACK 10 blister pack 2016-10-08 0000-00-00 No No Current