Aripiprazole
- Product NDC
- 65162-897
- 11-digit product format
- 651620897
- Labeler code
- 65162
- Product ID
- 65162-897_c125d854-8bb2-4467-83b4-c8a0e0f893c8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Aripiprazole
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Amneal Pharmaceuticals LLC
- Application
- ANDA204838
- Marketing category
- ANDA
- Marketing start
- 2016-06-20
- Substance
- ARIPIPRAZOLE
- Active strength
- 5 mg/1
- Pharmacologic classes
- Atypical Antipsychotic [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A204838-001 | ARIPIPRAZOLE | ARIPIPRAZOLE | 2MG | TABLET / ORAL | AB | 2016-06-17 | |
| A204838-002 | ARIPIPRAZOLE | ARIPIPRAZOLE | 5MG | TABLET / ORAL | AB | 2016-06-17 | |
| A204838-003 | ARIPIPRAZOLE | ARIPIPRAZOLE | 10MG | TABLET / ORAL | AB | 2016-06-17 | |
| A204838-004 | ARIPIPRAZOLE | ARIPIPRAZOLE | 15MG | TABLET / ORAL | AB | 2016-06-17 | |
| A204838-005 | ARIPIPRAZOLE | ARIPIPRAZOLE | 20MG | TABLET / ORAL | AB | 2016-06-17 | |
| A204838-006 | ARIPIPRAZOLE | ARIPIPRAZOLE | 30MG | TABLET / ORAL | AB | 2016-06-17 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A204838-001 | AB |
| A204838-002 | AB |
| A204838-003 | AB |
| A204838-004 | AB |
| A204838-005 | AB |
| A204838-006 | AB |
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.
| 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 | A204838-001 | ARIPIPRAZOLE | 2MG | TABLET / ORAL | AB | 2016-06-17 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A204838-002 | ARIPIPRAZOLE | 5MG | TABLET / ORAL | AB | 2016-06-17 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A204838-003 | ARIPIPRAZOLE | 10MG | TABLET / ORAL | AB | 2016-06-17 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A204838-004 | ARIPIPRAZOLE | 15MG | TABLET / ORAL | AB | 2016-06-17 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A204838-005 | ARIPIPRAZOLE | 20MG | TABLET / ORAL | AB | 2016-06-17 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A204838-006 | ARIPIPRAZOLE | 30MG | TABLET / ORAL | AB | 2016-06-17 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204838-001 | ARIPIPRAZOLE | 2MG | TABLET / ORAL | AB | 2016-06-17 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204838-002 | ARIPIPRAZOLE | 5MG | TABLET / ORAL | AB | 2016-06-17 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204838-003 | ARIPIPRAZOLE | 10MG | TABLET / ORAL | AB | 2016-06-17 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204838-004 | ARIPIPRAZOLE | 15MG | TABLET / ORAL | AB | 2016-06-17 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204838-005 | ARIPIPRAZOLE | 20MG | TABLET / ORAL | AB | 2016-06-17 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204838-006 | ARIPIPRAZOLE | 30MG | TABLET / ORAL | AB | 2016-06-17 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A204838-001 | ARIPIPRAZOLE | 2MG | TABLET / ORAL | AB | 2016-06-17 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A204838-002 | ARIPIPRAZOLE | 5MG | TABLET / ORAL | AB | 2016-06-17 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A204838-003 | ARIPIPRAZOLE | 10MG | TABLET / ORAL | AB | 2016-06-17 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A204838-004 | ARIPIPRAZOLE | 15MG | TABLET / ORAL | AB | 2016-06-17 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A204838-005 | ARIPIPRAZOLE | 20MG | TABLET / ORAL | AB | 2016-06-17 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A204838-006 | ARIPIPRAZOLE | 30MG | TABLET / ORAL | AB | 2016-06-17 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204838-001 | ARIPIPRAZOLE | 2MG | TABLET / ORAL | AB | 2016-06-17 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204838-002 | ARIPIPRAZOLE | 5MG | TABLET / ORAL | AB | 2016-06-17 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204838-003 | ARIPIPRAZOLE | 10MG | TABLET / ORAL | AB | 2016-06-17 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204838-004 | ARIPIPRAZOLE | 15MG | TABLET / ORAL | AB | 2016-06-17 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204838-005 | ARIPIPRAZOLE | 20MG | TABLET / ORAL | AB | 2016-06-17 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204838-006 | ARIPIPRAZOLE | 30MG | TABLET / ORAL | AB | 2016-06-17 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204838-001 | ARIPIPRAZOLE | 2MG | TABLET / ORAL | AB | 2016-06-17 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204838-002 | ARIPIPRAZOLE | 5MG | TABLET / ORAL | AB | 2016-06-17 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204838-003 | ARIPIPRAZOLE | 10MG | TABLET / ORAL | AB | 2016-06-17 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204838-004 | ARIPIPRAZOLE | 15MG | TABLET / ORAL | AB | 2016-06-17 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204838-005 | ARIPIPRAZOLE | 20MG | TABLET / ORAL | AB | 2016-06-17 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204838-006 | ARIPIPRAZOLE | 30MG | TABLET / ORAL | AB | 2016-06-17 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204838-001 | ARIPIPRAZOLE | 2MG | TABLET / ORAL | AB | 2016-06-17 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204838-002 | ARIPIPRAZOLE | 5MG | TABLET / ORAL | AB | 2016-06-17 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204838-003 | ARIPIPRAZOLE | 10MG | TABLET / ORAL | AB | 2016-06-17 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204838-004 | ARIPIPRAZOLE | 15MG | TABLET / ORAL | AB | 2016-06-17 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204838-005 | ARIPIPRAZOLE | 20MG | TABLET / ORAL | AB | 2016-06-17 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204838-006 | ARIPIPRAZOLE | 30MG | TABLET / ORAL | AB | 2016-06-17 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204838-001 | ARIPIPRAZOLE | 2MG | TABLET / ORAL | AB | 2016-06-17 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204838-002 | ARIPIPRAZOLE | 5MG | TABLET / ORAL | AB | 2016-06-17 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204838-003 | ARIPIPRAZOLE | 10MG | TABLET / ORAL | AB | 2016-06-17 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204838-004 | ARIPIPRAZOLE | 15MG | TABLET / ORAL | AB | 2016-06-17 | 2680178bc6a6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A204838-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A204838-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A204838-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A204838-004 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A204838-005 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A204838-006 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204838-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204838-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204838-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204838-004 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204838-005 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204838-006 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A204838-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A204838-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A204838-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A204838-004 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A204838-005 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A204838-006 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204838-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204838-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204838-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204838-004 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204838-005 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204838-006 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204838-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204838-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204838-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204838-004 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204838-005 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204838-006 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204838-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204838-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204838-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204838-004 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204838-005 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204838-006 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204838-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204838-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204838-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204838-004 | AB | 1 | 2680178bc6a6… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Aripiprazole
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ARIPIPRAZOLE | 5 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 82VFR53I78 | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 06dda03f-8481-46d6-af02-4f51e1a3a065 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 915afeb5-0b22-42c0-86ea-77abf1c5fe15 | Product name | 1 | 20250307 |
| 51c1e9bf-32c5-4a7b-b010-f93a90af7b6e | Product name | 1 | 20231010 |
| 351abe41-466c-4dd8-840a-0fdb68318bd5 | Product name | 1 | 20230316 |
| f52be47f-7aa7-46c0-b1fa-50c18dd50206 | Product name | 1 | 20201029 |
| 34645f32-2ac4-41bf-9c61-8107e4764a26 | Product name | 1 | 20181210 |
| f8ff9e17-cd6c-4547-98c3-f5db0d1fc25d | Product name | 1 | 20180110 |
| 14eaf619-f285-4cd0-9f39-d9dd8f3d9c02 | Product name | 1 | 20170824 |
| 8223ef47-de85-24dd-a9c7-5a041d2634a2 | Product name | 9 | 20170223 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 65162-897-03 | Aripiprazole | 30 in 1 BOTTLE | TABLET | 30 | 25 | |
| 65162-897-09 | Aripiprazole | 90 in 1 BOTTLE | TABLET | 90 | 25 | |
| 65162-897-11 | Aripiprazole | 1000 in 1 BOTTLE | TABLET | 1000 | 25 | |
| 65162-897-50 | Aripiprazole | 500 in 1 BOTTLE | TABLET | 500 | 25 |
DailyMed Dashboard NDC Coverage#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Aripiprazole | ARIPIPRAZOLE | REMEDYREPACK INC. | a1191a90-eb83-4a59-948c-b9774d2c83a5 | 2026-07-02 | Boxed warning, Warnings, Adverse reactions | 204838 ANDA204838 |
| Aripiprazole | ARIPIPRAZOLE | Major Pharmaceuticals | 573c6bb6-941f-4413-8c23-826025385864 | 2026-05-21 | Boxed warning, Warnings, Adverse reactions | 204838 ANDA204838 |
| Aripiprazole | ARIPIPRAZOLE | Amneal Pharmaceuticals LLC | 06dda03f-8481-46d6-af02-4f51e1a3a065 | 2025-02-20 | Boxed warning, Warnings, Adverse reactions | 204838 ANDA204838 65162-897 |
| Aripiprazole | ARIPIPRAZOLE | Bryant Ranch Prepack | 96172aa4-9e13-4eca-83d5-85a88c1782d3 | 2024-04-03 | Boxed warning, Warnings, Adverse reactions | 204838 ANDA204838 |
| Aripiprazole | ARIPIPRAZOLE | Proficient Rx LP | dbdc8fbe-c75f-4f17-a2cd-9f23802dcc5d | 2019-11-01 | Boxed warning, Warnings, Adverse reactions | 204838 ANDA204838 |
DailyMed RxNorm Mappings#
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 65162-897-03 | 65162089703 | 30 TABLET in 1 BOTTLE (65162-897-03) | 30 tablet | 2016-06-20 | 0000-00-00 | No | No | Current |
| 65162-897-09 | 65162089709 | 90 TABLET in 1 BOTTLE (65162-897-09) | 90 tablet | 2016-06-20 | 0000-00-00 | No | No | Current |
| 65162-897-11 | 65162089711 | 1000 TABLET in 1 BOTTLE (65162-897-11) | 1000 tablet | 2016-06-20 | 0000-00-00 | No | No | Current |
| 65162-897-50 | 65162089750 | 500 TABLET in 1 BOTTLE (65162-897-50) | 500 tablet | 2016-06-20 | 0000-00-00 | No | No | Current |