Home NDC 54838-570 Aripiprazole
Product NDC 54838-570
11-digit product format 548380570
Labeler code 54838
Product ID 54838-570_de0ee6f0-d4d7-4d86-9ff9-3ee2c687fccc
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Aripiprazole
Dosage form SOLUTION
Route ORAL
Labeler Lannett Company, Inc.
Application ANDA204171
Marketing category ANDA
Marketing start 2015-08-17
Substance ARIPIPRAZOLE
Active strength 1 mg/mL
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A204171-001 ARIPIPRAZOLE ARIPIPRAZOLE 1MG/ML SOLUTION / ORAL AA 2015-08-14
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A204171-001 AA
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 2 · 41 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 A204171-001 ARIPIPRAZOLE 1MG/ML SOLUTION / ORAL AA 2015-08-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204171-001 ARIPIPRAZOLE 1MG/ML SOLUTION / ORAL AA 2015-08-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A204171-001 ARIPIPRAZOLE 1MG/ML SOLUTION / ORAL AA 2015-08-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204171-001 ARIPIPRAZOLE 1MG/ML SOLUTION / ORAL AA 2015-08-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204171-001 ARIPIPRAZOLE 1MG/ML SOLUTION / ORAL AA 2015-08-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204171-001 ARIPIPRAZOLE 1MG/ML SOLUTION / ORAL AA 2015-08-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204171-001 ARIPIPRAZOLE 1MG/ML SOLUTION / ORAL AA 2015-08-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204171-001 ARIPIPRAZOLE 1MG/ML SOLUTION / ORAL AA 2015-08-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204171-001 ARIPIPRAZOLE 1MG/ML SOLUTION / ORAL AA 2015-08-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A204171-001 ARIPIPRAZOLE 1MG/ML SOLUTION / ORAL AA 2015-08-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204171-001 ARIPIPRAZOLE 1MG/ML SOLUTION / ORAL AA 2015-08-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204171-001 ARIPIPRAZOLE 1MG/ML SOLUTION / ORAL AA 2015-08-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204171-001 ARIPIPRAZOLE 1MG/ML SOLUTION / ORAL AA 2015-08-14 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A204171-001 ARIPIPRAZOLE 1MG/ML SOLUTION / ORAL AA 2015-08-14 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A204171-001 ARIPIPRAZOLE 1MG/ML SOLUTION / ORAL AA 2015-08-14 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A204171-001 ARIPIPRAZOLE 1MG/ML SOLUTION / ORAL AA 2015-08-14 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A204171-001 ARIPIPRAZOLE 1MG/ML SOLUTION / ORAL AA 2015-08-14 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A204171-001 ARIPIPRAZOLE 1MG/ML SOLUTION / ORAL AA 2015-08-14 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A204171-001 ARIPIPRAZOLE 1MG/ML SOLUTION / ORAL AA 2015-08-14 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A204171-001 ARIPIPRAZOLE 1MG/ML SOLUTION / ORAL AA 2015-08-14 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A204171-001 ARIPIPRAZOLE 1MG/ML SOLUTION / ORAL AA 2015-08-14 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A204171-001 ARIPIPRAZOLE 1MG/ML SOLUTION / ORAL AA 2015-08-14 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A204171-001 ARIPIPRAZOLE 1MG/ML SOLUTION / ORAL AA 2015-08-14 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A204171-001 ARIPIPRAZOLE 1MG/ML SOLUTION / ORAL AA 2015-08-14 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A204171-001 ARIPIPRAZOLE 1MG/ML SOLUTION / ORAL AA 2015-08-14 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A204171-001 ARIPIPRAZOLE 1MG/ML SOLUTION / ORAL AA 2015-08-14 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A204171-001 ARIPIPRAZOLE 1MG/ML SOLUTION / ORAL AA 2015-08-14 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A204171-001 ARIPIPRAZOLE 1MG/ML SOLUTION / ORAL AA 2015-08-14 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A204171-001 ARIPIPRAZOLE 1MG/ML SOLUTION / ORAL AA 2015-08-14 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A204171-001 ARIPIPRAZOLE 1MG/ML SOLUTION / ORAL AA 2015-08-14 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A204171-001 ARIPIPRAZOLE 1MG/ML SOLUTION / ORAL AA 2015-08-14 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A204171-001 ARIPIPRAZOLE 1MG/ML SOLUTION / ORAL AA 2015-08-14 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A204171-001 ARIPIPRAZOLE 1MG/ML SOLUTION / ORAL AA 2015-08-14 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A204171-001 ARIPIPRAZOLE 1MG/ML SOLUTION / ORAL AA 2015-08-14 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A204171-001 ARIPIPRAZOLE 1MG/ML SOLUTION / ORAL AA 2015-08-14 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A204171-001 ARIPIPRAZOLE 1MG/ML SOLUTION / ORAL AA 2015-08-14 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A204171-001 ARIPIPRAZOLE 1MG/ML SOLUTION / ORAL AA 2015-08-14 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A204171-001 ARIPIPRAZOLE 1MG/ML SOLUTION / ORAL AA 2015-08-14 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A204171-001 ARIPIPRAZOLE 1MG/ML SOLUTION / ORAL AA 2015-08-14 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A204171-001 ARIPIPRAZOLE 1MG/ML SOLUTION / ORAL AA 2015-08-14 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 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 1 mg/mL
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 485496 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 54838-570-59 Aripiprazole 150 mL in 1 BOTTLE, PLASTIC SOLUTION 150 28 54838-570-70 Aripiprazole 237 mL in 1 BOTTLE, PLASTIC SOLUTION 237 28
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ARIPIPRAZOLE ACTIVE INGREDIENT 82VFR53I78 ARIPIPRAZOLE ORAL SOLUTION (ARIPIPRAZOLE) SOLUTION [SILARX PHARMACEUTICALS, INC] 3 ARIPIPRAZOLE ACTIVE MOIETY 82VFR53I78 ARIPIPRAZOLE ORAL SOLUTION (ARIPIPRAZOLE) SOLUTION [SILARX PHARMACEUTICALS, INC] 3 BUTYLATED HYDROXYANISOLE INACTIVE INGREDIENT REK4960K2U ARIPIPRAZOLE ORAL SOLUTION (ARIPIPRAZOLE) SOLUTION [SILARX PHARMACEUTICALS, INC] 3 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T ARIPIPRAZOLE ORAL SOLUTION (ARIPIPRAZOLE) SOLUTION [SILARX PHARMACEUTICALS, INC] 3 PHOSPHORIC ACID INACTIVE INGREDIENT E4GA8884NN ARIPIPRAZOLE ORAL SOLUTION (ARIPIPRAZOLE) SOLUTION [SILARX PHARMACEUTICALS, INC] 3 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 ARIPIPRAZOLE ORAL SOLUTION (ARIPIPRAZOLE) SOLUTION [SILARX PHARMACEUTICALS, INC] 3 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH ARIPIPRAZOLE ORAL SOLUTION (ARIPIPRAZOLE) SOLUTION [SILARX PHARMACEUTICALS, INC] 3 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I ARIPIPRAZOLE ORAL SOLUTION (ARIPIPRAZOLE) SOLUTION [SILARX PHARMACEUTICALS, INC] 3 SUCRALOSE INACTIVE INGREDIENT 96K6UQ3ZD4 ARIPIPRAZOLE ORAL SOLUTION (ARIPIPRAZOLE) SOLUTION [SILARX PHARMACEUTICALS, INC] 3 WATER INACTIVE INGREDIENT 059QF0KO0R ARIPIPRAZOLE ORAL SOLUTION (ARIPIPRAZOLE) SOLUTION [SILARX PHARMACEUTICALS, INC] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 54838-570 ARIPIPRAZOLE SOLUTION [LANNETT COMPANY, INC.] 27 Current NDC, Legacy NDC, 2 package rows 20250130_e7292c4c-e332-4ed4-9086-f130d223b6ae.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 54838-570-59 54838057059 150 mL in 1 BOTTLE, PLASTIC (54838-570-59) 150 ml 2015-08-17 0000-00-00 No No Current 54838-570-70 54838057070 237 mL in 1 BOTTLE, PLASTIC (54838-570-70) 237 ml 2015-08-17 0000-00-00 No No Current