Aripiprazole
- Product NDC
- 65862-665
- Requested package NDC
- 65862-665-01
- 11-digit product format
- 658620665
- Labeler code
- 65862
- Product ID
- 65862-665_9f7087f5-c8ef-4c1f-9a25-228ed3149b01
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Aripiprazole
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Aurobindo Pharma Limited
- Application
- ANDA203908
- Marketing category
- ANDA
- Marketing start
- 2015-10-08
- Substance
- ARIPIPRAZOLE
- Active strength
- 20 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 |
|---|---|---|---|---|---|---|---|
| A203908-001 | ARIPIPRAZOLE | ARIPIPRAZOLE | 2MG | TABLET / ORAL | AB | 2015-10-08 | |
| A203908-002 | ARIPIPRAZOLE | ARIPIPRAZOLE | 5MG | TABLET / ORAL | AB | 2015-10-08 | |
| A203908-003 | ARIPIPRAZOLE | ARIPIPRAZOLE | 10MG | TABLET / ORAL | AB | 2015-10-08 | |
| A203908-004 | ARIPIPRAZOLE | ARIPIPRAZOLE | 15MG | TABLET / ORAL | AB | 2015-10-08 | |
| A203908-005 | ARIPIPRAZOLE | ARIPIPRAZOLE | 20MG | TABLET / ORAL | AB | 2015-10-08 | |
| A203908-006 | ARIPIPRAZOLE | ARIPIPRAZOLE | 30MG | TABLET / ORAL | AB | 2015-10-08 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A203908-001 | AB |
| A203908-002 | AB |
| A203908-003 | AB |
| A203908-004 | AB |
| A203908-005 | AB |
| A203908-006 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A203908-001 | ARIPIPRAZOLE | 2MG | TABLET / ORAL | AB | 2015-10-08 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A203908-002 | ARIPIPRAZOLE | 5MG | TABLET / ORAL | AB | 2015-10-08 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A203908-003 | ARIPIPRAZOLE | 10MG | TABLET / ORAL | AB | 2015-10-08 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A203908-004 | ARIPIPRAZOLE | 15MG | TABLET / ORAL | AB | 2015-10-08 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A203908-005 | ARIPIPRAZOLE | 20MG | TABLET / ORAL | AB | 2015-10-08 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A203908-006 | ARIPIPRAZOLE | 30MG | TABLET / ORAL | AB | 2015-10-08 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A203908-001 | ARIPIPRAZOLE | 2MG | TABLET / ORAL | AB | 2015-10-08 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A203908-002 | ARIPIPRAZOLE | 5MG | TABLET / ORAL | AB | 2015-10-08 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A203908-003 | ARIPIPRAZOLE | 10MG | TABLET / ORAL | AB | 2015-10-08 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A203908-004 | ARIPIPRAZOLE | 15MG | TABLET / ORAL | AB | 2015-10-08 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A203908-005 | ARIPIPRAZOLE | 20MG | TABLET / ORAL | AB | 2015-10-08 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A203908-006 | ARIPIPRAZOLE | 30MG | TABLET / ORAL | AB | 2015-10-08 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203908-001 | ARIPIPRAZOLE | 2MG | TABLET / ORAL | AB | 2015-10-08 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203908-002 | ARIPIPRAZOLE | 5MG | TABLET / ORAL | AB | 2015-10-08 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203908-003 | ARIPIPRAZOLE | 10MG | TABLET / ORAL | AB | 2015-10-08 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203908-004 | ARIPIPRAZOLE | 15MG | TABLET / ORAL | AB | 2015-10-08 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203908-005 | ARIPIPRAZOLE | 20MG | TABLET / ORAL | AB | 2015-10-08 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203908-006 | ARIPIPRAZOLE | 30MG | TABLET / ORAL | AB | 2015-10-08 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A203908-001 | ARIPIPRAZOLE | 2MG | TABLET / ORAL | AB | 2015-10-08 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A203908-002 | ARIPIPRAZOLE | 5MG | TABLET / ORAL | AB | 2015-10-08 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A203908-003 | ARIPIPRAZOLE | 10MG | TABLET / ORAL | AB | 2015-10-08 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A203908-004 | ARIPIPRAZOLE | 15MG | TABLET / ORAL | AB | 2015-10-08 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A203908-005 | ARIPIPRAZOLE | 20MG | TABLET / ORAL | AB | 2015-10-08 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A203908-006 | ARIPIPRAZOLE | 30MG | TABLET / ORAL | AB | 2015-10-08 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203908-001 | ARIPIPRAZOLE | 2MG | TABLET / ORAL | AB | 2015-10-08 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203908-002 | ARIPIPRAZOLE | 5MG | TABLET / ORAL | AB | 2015-10-08 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203908-003 | ARIPIPRAZOLE | 10MG | TABLET / ORAL | AB | 2015-10-08 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203908-004 | ARIPIPRAZOLE | 15MG | TABLET / ORAL | AB | 2015-10-08 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203908-005 | ARIPIPRAZOLE | 20MG | TABLET / ORAL | AB | 2015-10-08 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203908-006 | ARIPIPRAZOLE | 30MG | TABLET / ORAL | AB | 2015-10-08 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203908-001 | ARIPIPRAZOLE | 2MG | TABLET / ORAL | AB | 2015-10-08 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203908-002 | ARIPIPRAZOLE | 5MG | TABLET / ORAL | AB | 2015-10-08 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203908-003 | ARIPIPRAZOLE | 10MG | TABLET / ORAL | AB | 2015-10-08 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203908-004 | ARIPIPRAZOLE | 15MG | TABLET / ORAL | AB | 2015-10-08 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203908-005 | ARIPIPRAZOLE | 20MG | TABLET / ORAL | AB | 2015-10-08 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203908-006 | ARIPIPRAZOLE | 30MG | TABLET / ORAL | AB | 2015-10-08 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203908-001 | ARIPIPRAZOLE | 2MG | TABLET / ORAL | AB | 2015-10-08 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203908-002 | ARIPIPRAZOLE | 5MG | TABLET / ORAL | AB | 2015-10-08 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203908-003 | ARIPIPRAZOLE | 10MG | TABLET / ORAL | AB | 2015-10-08 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203908-004 | ARIPIPRAZOLE | 15MG | TABLET / ORAL | AB | 2015-10-08 | 03ed91905a0d… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A203908-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A203908-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A203908-003 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A203908-004 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A203908-005 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A203908-006 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A203908-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A203908-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A203908-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A203908-004 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A203908-005 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A203908-006 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203908-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203908-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203908-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203908-004 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203908-005 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203908-006 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A203908-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A203908-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A203908-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A203908-004 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A203908-005 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A203908-006 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203908-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203908-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203908-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203908-004 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203908-005 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203908-006 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203908-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203908-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203908-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203908-004 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203908-005 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203908-006 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203908-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203908-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203908-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203908-004 | AB | 1 | 03ed91905a0d… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Aripiprazole
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ARIPIPRAZOLE | 20 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 82VFR53I78 | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 7bf7d35e-46a1-4e8f-aeb5-8a93223a4abc | 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 |
|---|---|---|---|---|---|---|
| 65862-665-01 | Aripiprazole | 100 in 1 BOTTLE | TABLET | 100 | 17 | |
| 65862-665-05 | Aripiprazole | 500 in 1 BOTTLE | TABLET | 500 | 17 | |
| 65862-665-10 | Aripiprazole | 10 in 1 BLISTER PACK | TABLET | 10 | 17 | |
| 65862-665-30 | Aripiprazole | 30 in 1 BOTTLE | TABLET | 30 | 17 | |
| 65862-665-78 | Aripiprazole | 10 in 1 CARTON | TABLET | 10 | 17 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 65862-665-05 | EA - Each | 65862-665 | 51b553b6-af7c-4672-9fd1-28c6bbfac04c | 1 | 2016-03-04 |
| 65862-665-30 | EA - Each | 65862-665 | d080f6db-04f4-4df6-9fb7-463d4f56670c | 1 | 2015-11-12 |
DailyMed Socrata Ingredients#
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 | Aurobindo Pharma Limited | 7bf7d35e-46a1-4e8f-aeb5-8a93223a4abc | 2026-07-23 | Boxed warning, Warnings, Adverse reactions | 203908 ANDA203908 65862-665-01 65862-665 65862066501 |
| Aripiprazole | ARIPIPRAZOLE | A-S Medication Solutions | a8edb057-18a3-446d-8af0-672c97933a88 | 2025-06-03 | Boxed warning, Warnings, Adverse reactions | 203908 ANDA203908 |
| Aripiprazole | ARIPIPRAZOLE | Bryant Ranch Prepack | 385301f5-e59d-42d5-8544-aadf0ee0c967 | 2025-04-29 | Boxed warning, Warnings, Adverse reactions | 203908 ANDA203908 |
| Aripiprazole | ARIPIPRAZOLE | A-S Medication Solutions | c8a94428-b6d2-428b-a3a5-7b983d572fab | 2024-06-05 | Boxed warning, Warnings, Adverse reactions | 203908 ANDA203908 |
| Aripiprazole | ARIPIPRAZOLE | Proficient Rx LP | fbd81df7-8482-493e-bfc5-a3352f466b9e | 2023-10-01 | Boxed warning, Warnings, Adverse reactions | 203908 ANDA203908 |
| Aripiprazole | ARIPIPRAZOLE | Proficient Rx LP | 19a3c2f2-11eb-4ec9-ac38-134168bdf99c | 2022-08-01 | Boxed warning, Warnings, Adverse reactions | 203908 ANDA203908 |
| Aripiprazole | ARIPIPRAZOLE | Proficient Rx LP | 11202c0a-7401-41c9-b1e7-d93739fcd36f | 2022-06-01 | Boxed warning, Warnings, Adverse reactions | 203908 ANDA203908 |
DailyMed RxNorm Mappings#
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 65862-665-01 | 65862066501 | 100 TABLET in 1 BOTTLE (65862-665-01) | 100 tablet | 2015-10-08 | 0000-00-00 | No | No | Current |