Aripiprazole
- Product NDC
- 27241-053
- 11-digit product format
- 272410053
- Labeler code
- 27241
- Product ID
- 27241-053_2a724a23-cf45-4d22-90f5-ebe68f9b7ab9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Aripiprazole
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Ajanta Pharma USA Inc.
- Application
- ANDA206174
- Marketing category
- ANDA
- Marketing start
- 2017-05-30
- Substance
- ARIPIPRAZOLE
- Active strength
- 10 mg/1
- Pharmacologic classes
- Atypical Antipsychotic [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A206174-001 | ARIPIPRAZOLE | ARIPIPRAZOLE | 2MG | TABLET / ORAL | AB | 2016-09-12 | |
| A206174-002 | ARIPIPRAZOLE | ARIPIPRAZOLE | 5MG | TABLET / ORAL | AB | 2016-09-12 | |
| A206174-003 | ARIPIPRAZOLE | ARIPIPRAZOLE | 10MG | TABLET / ORAL | AB | 2016-09-12 | |
| A206174-004 | ARIPIPRAZOLE | ARIPIPRAZOLE | 15MG | TABLET / ORAL | AB | 2016-09-12 | |
| A206174-005 | ARIPIPRAZOLE | ARIPIPRAZOLE | 20MG | TABLET / ORAL | AB | 2016-09-12 | |
| A206174-006 | ARIPIPRAZOLE | ARIPIPRAZOLE | 30MG | TABLET / ORAL | AB | 2016-09-12 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A206174-001 | AB |
| A206174-002 | AB |
| A206174-003 | AB |
| A206174-004 | AB |
| A206174-005 | AB |
| A206174-006 | 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 | A206174-001 | ARIPIPRAZOLE | 2MG | TABLET / ORAL | AB | 2016-09-12 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A206174-002 | ARIPIPRAZOLE | 5MG | TABLET / ORAL | AB | 2016-09-12 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A206174-003 | ARIPIPRAZOLE | 10MG | TABLET / ORAL | AB | 2016-09-12 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A206174-004 | ARIPIPRAZOLE | 15MG | TABLET / ORAL | AB | 2016-09-12 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A206174-005 | ARIPIPRAZOLE | 20MG | TABLET / ORAL | AB | 2016-09-12 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A206174-006 | ARIPIPRAZOLE | 30MG | TABLET / ORAL | AB | 2016-09-12 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206174-001 | ARIPIPRAZOLE | 2MG | TABLET / ORAL | AB | 2016-09-12 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206174-002 | ARIPIPRAZOLE | 5MG | TABLET / ORAL | AB | 2016-09-12 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206174-003 | ARIPIPRAZOLE | 10MG | TABLET / ORAL | AB | 2016-09-12 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206174-004 | ARIPIPRAZOLE | 15MG | TABLET / ORAL | AB | 2016-09-12 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206174-005 | ARIPIPRAZOLE | 20MG | TABLET / ORAL | AB | 2016-09-12 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206174-006 | ARIPIPRAZOLE | 30MG | TABLET / ORAL | AB | 2016-09-12 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A206174-001 | ARIPIPRAZOLE | 2MG | TABLET / ORAL | AB | 2016-09-12 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A206174-002 | ARIPIPRAZOLE | 5MG | TABLET / ORAL | AB | 2016-09-12 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A206174-003 | ARIPIPRAZOLE | 10MG | TABLET / ORAL | AB | 2016-09-12 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A206174-004 | ARIPIPRAZOLE | 15MG | TABLET / ORAL | AB | 2016-09-12 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A206174-005 | ARIPIPRAZOLE | 20MG | TABLET / ORAL | AB | 2016-09-12 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A206174-006 | ARIPIPRAZOLE | 30MG | TABLET / ORAL | AB | 2016-09-12 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206174-001 | ARIPIPRAZOLE | 2MG | TABLET / ORAL | AB | 2016-09-12 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206174-002 | ARIPIPRAZOLE | 5MG | TABLET / ORAL | AB | 2016-09-12 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206174-003 | ARIPIPRAZOLE | 10MG | TABLET / ORAL | AB | 2016-09-12 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206174-004 | ARIPIPRAZOLE | 15MG | TABLET / ORAL | AB | 2016-09-12 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206174-005 | ARIPIPRAZOLE | 20MG | TABLET / ORAL | AB | 2016-09-12 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206174-006 | ARIPIPRAZOLE | 30MG | TABLET / ORAL | AB | 2016-09-12 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A206174-001 | ARIPIPRAZOLE | 2MG | TABLET / ORAL | AB | 2016-09-12 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A206174-002 | ARIPIPRAZOLE | 5MG | TABLET / ORAL | AB | 2016-09-12 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A206174-003 | ARIPIPRAZOLE | 10MG | TABLET / ORAL | AB | 2016-09-12 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A206174-004 | ARIPIPRAZOLE | 15MG | TABLET / ORAL | AB | 2016-09-12 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A206174-005 | ARIPIPRAZOLE | 20MG | TABLET / ORAL | AB | 2016-09-12 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A206174-006 | ARIPIPRAZOLE | 30MG | TABLET / ORAL | AB | 2016-09-12 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A206174-001 | ARIPIPRAZOLE | 2MG | TABLET / ORAL | AB | 2016-09-12 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A206174-002 | ARIPIPRAZOLE | 5MG | TABLET / ORAL | AB | 2016-09-12 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A206174-003 | ARIPIPRAZOLE | 10MG | TABLET / ORAL | AB | 2016-09-12 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A206174-004 | ARIPIPRAZOLE | 15MG | TABLET / ORAL | AB | 2016-09-12 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A206174-005 | ARIPIPRAZOLE | 20MG | TABLET / ORAL | AB | 2016-09-12 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A206174-006 | ARIPIPRAZOLE | 30MG | TABLET / ORAL | AB | 2016-09-12 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A206174-001 | ARIPIPRAZOLE | 2MG | TABLET / ORAL | AB | 2016-09-12 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A206174-002 | ARIPIPRAZOLE | 5MG | TABLET / ORAL | AB | 2016-09-12 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A206174-003 | ARIPIPRAZOLE | 10MG | TABLET / ORAL | AB | 2016-09-12 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A206174-004 | ARIPIPRAZOLE | 15MG | TABLET / ORAL | AB | 2016-09-12 | 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 | A206174-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A206174-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A206174-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A206174-004 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A206174-005 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A206174-006 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206174-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206174-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206174-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206174-004 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206174-005 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206174-006 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A206174-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A206174-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A206174-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A206174-004 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A206174-005 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A206174-006 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206174-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206174-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206174-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206174-004 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206174-005 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206174-006 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A206174-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A206174-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A206174-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A206174-004 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A206174-005 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A206174-006 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A206174-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A206174-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A206174-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A206174-004 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A206174-005 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A206174-006 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A206174-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A206174-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A206174-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A206174-004 | AB | 1 | 2680178bc6a6… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Aripiprazole
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ARIPIPRAZOLE | 10 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 82VFR53I78 | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| d0f910b5-adef-4a93-9369-70f1ed541503 | 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 |
| 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 |
|---|---|---|---|---|---|---|
| 27241-053-03 | Aripiprazole | 30 in 1 BOTTLE | TABLET | 30 | 20 | |
| 27241-053-08 | Aripiprazole | 500 in 1 BOTTLE | TABLET | 500 | 20 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 27241-053-03 | EA - Each | 27241-053 | 3dd6134a-b392-4bb4-a3ae-ea182861edaa | 1 | 2016-11-08 |
| 27241-053-08 | EA - Each | 27241-053 | a2affe61-a9a0-491a-8e72-1587783e0614 | 1 | 2017-11-06 |
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 | Bryant Ranch Prepack | 69af5199-f872-4298-8d09-035e2127d3d4 | 2026-06-29 | Boxed warning, Warnings, Adverse reactions | 206174 ANDA206174 |
| Aripiprazole | ARIPIPRAZOLE | Unit Dose Solutions, Inc. | 535f4fbd-b6a7-7611-e063-6294a90a5c43 | 2026-06-03 | Boxed warning, Warnings, Adverse reactions | 206174 ANDA206174 |
| Aripiprazole | ARIPIPRAZOLE | Bryant Ranch Prepack | c092a736-16e2-4dd0-8769-cb766a62f4d9 | 2026-05-13 | Boxed warning, Warnings, Adverse reactions | 206174 ANDA206174 |
| Aripiprazole | ARIPIPRAZOLE | Preferred Pharmaceuticals, Inc. | 36fb0c13-dfae-46ac-bb71-0b53fe5649f4 | 2026-03-05 | Boxed warning, Warnings, Adverse reactions | 206174 ANDA206174 |
| Aripiprazole | ARIPIPRAZOLE | REMEDYREPACK INC. | 2bc00231-c2e7-4b9d-93a1-fb796fd8d591 | 2026-02-11 | Boxed warning, Warnings, Adverse reactions | 206174 ANDA206174 |
| Aripiprazole | ARIPIPRAZOLE | Coupler LLC | 47430dfa-9377-6c31-e063-6394a90a86a9 | 2025-12-31 | Boxed warning, Warnings, Adverse reactions | 206174 ANDA206174 |
| Aripiprazole | ARIPIPRAZOLE | Quallent Pharmaceuticals Health LLC | 0e0d42ad-f4c6-4e30-adc2-ab1d122428ec | 2025-12-04 | Boxed warning, Warnings, Adverse reactions | 206174 ANDA206174 |
| Aripiprazole | ARIPIPRAZOLE | Ajanta Pharma USA Inc. | d0f910b5-adef-4a93-9369-70f1ed541503 | 2025-10-10 | Boxed warning, Warnings, Adverse reactions | 206174 ANDA206174 27241-053 |
| Aripiprazole | ARIPIPRAZOLE | A-S Medication Solutions | 13339e7f-a8b4-430d-b623-47372de98348 | 2024-06-05 | Boxed warning, Warnings, Adverse reactions | 206174 ANDA206174 |
| Aripiprazole | ARIPIPRAZOLE | Bryant Ranch Prepack | fd2fa4da-2ee9-4965-b1f8-ce1c8b73ba93 | 2023-11-22 | Boxed warning, Warnings, Adverse reactions | 206174 ANDA206174 |
DailyMed RxNorm Mappings#
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 27241-053-03 | 27241005303 | 30 TABLET in 1 BOTTLE (27241-053-03) | 30 tablet | 2017-05-30 | 0000-00-00 | No | No | Current |
| 27241-053-08 | 27241005308 | 500 TABLET in 1 BOTTLE (27241-053-08) | 500 tablet | 2017-05-30 | 0000-00-00 | No | No | Current |