Home NDC 65162-893 Aripiprazole
Product NDC 65162-893
11-digit product format 651620893
Labeler code 65162
Product ID 65162-893_d6606ae3-90c2-4332-ab9f-da0b1c593c88
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Aripiprazole
Dosage form SOLUTION
Route ORAL
Labeler Amneal Pharmaceuticals LLC
Application ANDA203906
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 43 .
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 A203906-001 ARIPIPRAZOLE ARIPIPRAZOLE 1MG/ML SOLUTION / ORAL AA RS 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 A203906-001 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 · 43 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 A203906-001 ARIPIPRAZOLE 1MG/ML SOLUTION / ORAL AA RS 2015-08-14 84e616aacf4f…2026-08-18 06:07:40 2026-07 A203906-001 ARIPIPRAZOLE 1MG/ML SOLUTION / ORAL AA RS 2015-08-14 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A203906-001 ARIPIPRAZOLE 1MG/ML SOLUTION / ORAL AA RS 2015-08-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203906-001 ARIPIPRAZOLE 1MG/ML SOLUTION / ORAL AA RS 2015-08-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203906-001 ARIPIPRAZOLE 1MG/ML SOLUTION / ORAL AA RS 2015-08-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203906-001 ARIPIPRAZOLE 1MG/ML SOLUTION / ORAL AA RS 2015-08-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203906-001 ARIPIPRAZOLE 1MG/ML SOLUTION / ORAL AA RS 2015-08-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203906-001 ARIPIPRAZOLE 1MG/ML SOLUTION / ORAL AA RS 2015-08-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203906-001 ARIPIPRAZOLE 1MG/ML SOLUTION / ORAL AA RS 2015-08-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203906-001 ARIPIPRAZOLE 1MG/ML SOLUTION / ORAL AA RS 2015-08-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203906-001 ARIPIPRAZOLE 1MG/ML SOLUTION / ORAL AA RS 2015-08-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A203906-001 ARIPIPRAZOLE 1MG/ML SOLUTION / ORAL AA RS 2015-08-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203906-001 ARIPIPRAZOLE 1MG/ML SOLUTION / ORAL AA RS 2015-08-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203906-001 ARIPIPRAZOLE 1MG/ML SOLUTION / ORAL AA RS 2015-08-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203906-001 ARIPIPRAZOLE 1MG/ML SOLUTION / ORAL AA RS 2015-08-14 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A203906-001 ARIPIPRAZOLE 1MG/ML SOLUTION / ORAL AA RS 2015-08-14 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203906-001 ARIPIPRAZOLE 1MG/ML SOLUTION / ORAL AA RS 2015-08-14 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A203906-001 ARIPIPRAZOLE 1MG/ML SOLUTION / ORAL AA RS 2015-08-14 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A203906-001 ARIPIPRAZOLE 1MG/ML SOLUTION / ORAL AA RS 2015-08-14 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A203906-001 ARIPIPRAZOLE 1MG/ML SOLUTION / ORAL AA RS 2015-08-14 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A203906-001 ARIPIPRAZOLE 1MG/ML SOLUTION / ORAL AA RS 2015-08-14 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A203906-001 ARIPIPRAZOLE 1MG/ML SOLUTION / ORAL AA RS 2015-08-14 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A203906-001 ARIPIPRAZOLE 1MG/ML SOLUTION / ORAL AA RS 2015-08-14 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A203906-001 ARIPIPRAZOLE 1MG/ML SOLUTION / ORAL AA RS 2015-08-14 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A203906-001 ARIPIPRAZOLE 1MG/ML SOLUTION / ORAL AA RS 2015-08-14 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A203906-001 ARIPIPRAZOLE 1MG/ML SOLUTION / ORAL AA RS 2015-08-14 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A203906-001 ARIPIPRAZOLE 1MG/ML SOLUTION / ORAL AA RS 2015-08-14 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A203906-001 ARIPIPRAZOLE 1MG/ML SOLUTION / ORAL AA RS 2015-08-14 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A203906-001 ARIPIPRAZOLE 1MG/ML SOLUTION / ORAL AA RS 2015-08-14 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A203906-001 ARIPIPRAZOLE 1MG/ML SOLUTION / ORAL AA RS 2015-08-14 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A203906-001 ARIPIPRAZOLE 1MG/ML SOLUTION / ORAL AA RS 2015-08-14 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A203906-001 ARIPIPRAZOLE 1MG/ML SOLUTION / ORAL AA RS 2015-08-14 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A203906-001 ARIPIPRAZOLE 1MG/ML SOLUTION / ORAL AA RS 2015-08-14 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A203906-001 ARIPIPRAZOLE 1MG/ML SOLUTION / ORAL AA RS 2015-08-14 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A203906-001 ARIPIPRAZOLE 1MG/ML SOLUTION / ORAL AA RS 2015-08-14 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A203906-001 ARIPIPRAZOLE 1MG/ML SOLUTION / ORAL AA RS 2015-08-14 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A203906-001 ARIPIPRAZOLE 1MG/ML SOLUTION / ORAL AA RS 2015-08-14 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A203906-001 ARIPIPRAZOLE 1MG/ML SOLUTION / ORAL AA RS 2015-08-14 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A203906-001 ARIPIPRAZOLE 1MG/ML SOLUTION / ORAL AA RS 2015-08-14 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A203906-001 ARIPIPRAZOLE 1MG/ML SOLUTION / ORAL AA RS 2015-08-14 f41ea6bd6efb…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 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 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 65162-893-74 Aripiprazole 1 in 1 CARTON SOLUTION 1 34 65162-893-74 Aripiprazole 150 mL in 1 BOTTLE SOLUTION 150 34
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ARIPIPRAZOLE ACTIVE INGREDIENT 82VFR53I78 ARIPIPRAZOLE SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 13 ARIPIPRAZOLE ACTIVE MOIETY 82VFR53I78 ARIPIPRAZOLE SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 13 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K ARIPIPRAZOLE SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 13 FRUCTOSE INACTIVE INGREDIENT 6YSS42VSEV ARIPIPRAZOLE SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 13 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX ARIPIPRAZOLE SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 13 MALIC ACID INACTIVE INGREDIENT 817L1N4CKP ARIPIPRAZOLE SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 13 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T ARIPIPRAZOLE SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 13 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 ARIPIPRAZOLE SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 13 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH ARIPIPRAZOLE SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 13 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I ARIPIPRAZOLE SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 13 SUCROSE INACTIVE INGREDIENT C151H8M554 ARIPIPRAZOLE SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 13 WATER INACTIVE INGREDIENT 059QF0KO0R ARIPIPRAZOLE SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 13
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65162-893 ARIPIPRAZOLE SOLUTION [AMNEAL PHARMACEUTICALS LLC] 34 Current NDC, Legacy NDC, 2 package rows 20250227_7f272100-e02f-4a16-bb39-a2bf844db4f9.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 65162-893-74 65162089374 1 BOTTLE in 1 CARTON (65162-893-74) / 150 mL in 1 BOTTLE 1 bottle 2015-08-17 0000-00-00 No No Current