Aripiprazole
- Product NDC
- 67046-0492
- 11-digit product format
- 670460492
- Labeler code
- 67046
- Product ID
- 67046-0492_50214bd1-450a-8497-e063-6294a90af276
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Aripiprazole
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Coupler LLC
- Application
- ANDA207105
- Marketing category
- ANDA
- Marketing start
- 2026-04-23
- Substance
- ARIPIPRAZOLE
- Active strength
- 10 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 |
|---|---|---|---|---|---|---|---|
| A207105-001 | ARIPIPRAZOLE | ARIPIPRAZOLE | 2MG | TABLET / ORAL | AB | 2019-02-21 | |
| A207105-002 | ARIPIPRAZOLE | ARIPIPRAZOLE | 5MG | TABLET / ORAL | AB | 2019-02-21 | |
| A207105-003 | ARIPIPRAZOLE | ARIPIPRAZOLE | 10MG | TABLET / ORAL | AB | 2019-02-21 | |
| A207105-004 | ARIPIPRAZOLE | ARIPIPRAZOLE | 15MG | TABLET / ORAL | AB | 2019-02-21 | |
| A207105-005 | ARIPIPRAZOLE | ARIPIPRAZOLE | 20MG | TABLET / ORAL | AB | 2019-02-21 | |
| A207105-006 | ARIPIPRAZOLE | ARIPIPRAZOLE | 30MG | TABLET / ORAL | AB | 2019-02-21 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A207105-001 | AB |
| A207105-002 | AB |
| A207105-003 | AB |
| A207105-004 | AB |
| A207105-005 | AB |
| A207105-006 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A207105-001 | ARIPIPRAZOLE | 2MG | TABLET / ORAL | AB | 2019-02-21 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A207105-002 | ARIPIPRAZOLE | 5MG | TABLET / ORAL | AB | 2019-02-21 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A207105-003 | ARIPIPRAZOLE | 10MG | TABLET / ORAL | AB | 2019-02-21 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A207105-004 | ARIPIPRAZOLE | 15MG | TABLET / ORAL | AB | 2019-02-21 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A207105-005 | ARIPIPRAZOLE | 20MG | TABLET / ORAL | AB | 2019-02-21 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A207105-006 | ARIPIPRAZOLE | 30MG | TABLET / ORAL | AB | 2019-02-21 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A207105-001 | ARIPIPRAZOLE | 2MG | TABLET / ORAL | AB | 2019-02-21 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A207105-002 | ARIPIPRAZOLE | 5MG | TABLET / ORAL | AB | 2019-02-21 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A207105-003 | ARIPIPRAZOLE | 10MG | TABLET / ORAL | AB | 2019-02-21 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A207105-004 | ARIPIPRAZOLE | 15MG | TABLET / ORAL | AB | 2019-02-21 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A207105-005 | ARIPIPRAZOLE | 20MG | TABLET / ORAL | AB | 2019-02-21 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A207105-006 | ARIPIPRAZOLE | 30MG | TABLET / ORAL | AB | 2019-02-21 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A207105-001 | ARIPIPRAZOLE | 2MG | TABLET / ORAL | AB | 2019-02-21 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A207105-002 | ARIPIPRAZOLE | 5MG | TABLET / ORAL | AB | 2019-02-21 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A207105-003 | ARIPIPRAZOLE | 10MG | TABLET / ORAL | AB | 2019-02-21 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A207105-004 | ARIPIPRAZOLE | 15MG | TABLET / ORAL | AB | 2019-02-21 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A207105-005 | ARIPIPRAZOLE | 20MG | TABLET / ORAL | AB | 2019-02-21 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A207105-006 | ARIPIPRAZOLE | 30MG | TABLET / ORAL | AB | 2019-02-21 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207105-001 | ARIPIPRAZOLE | 2MG | TABLET / ORAL | AB | 2019-02-21 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207105-002 | ARIPIPRAZOLE | 5MG | TABLET / ORAL | AB | 2019-02-21 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207105-003 | ARIPIPRAZOLE | 10MG | TABLET / ORAL | AB | 2019-02-21 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207105-004 | ARIPIPRAZOLE | 15MG | TABLET / ORAL | AB | 2019-02-21 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207105-005 | ARIPIPRAZOLE | 20MG | TABLET / ORAL | AB | 2019-02-21 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207105-006 | ARIPIPRAZOLE | 30MG | TABLET / ORAL | AB | 2019-02-21 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A207105-001 | ARIPIPRAZOLE | 2MG | TABLET / ORAL | AB | 2019-02-21 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A207105-002 | ARIPIPRAZOLE | 5MG | TABLET / ORAL | AB | 2019-02-21 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A207105-003 | ARIPIPRAZOLE | 10MG | TABLET / ORAL | AB | 2019-02-21 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A207105-004 | ARIPIPRAZOLE | 15MG | TABLET / ORAL | AB | 2019-02-21 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A207105-005 | ARIPIPRAZOLE | 20MG | TABLET / ORAL | AB | 2019-02-21 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A207105-006 | ARIPIPRAZOLE | 30MG | TABLET / ORAL | AB | 2019-02-21 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207105-001 | ARIPIPRAZOLE | 2MG | TABLET / ORAL | AB | 2019-02-21 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207105-002 | ARIPIPRAZOLE | 5MG | TABLET / ORAL | AB | 2019-02-21 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207105-003 | ARIPIPRAZOLE | 10MG | TABLET / ORAL | AB | 2019-02-21 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207105-004 | ARIPIPRAZOLE | 15MG | TABLET / ORAL | AB | 2019-02-21 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207105-005 | ARIPIPRAZOLE | 20MG | TABLET / ORAL | AB | 2019-02-21 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207105-006 | ARIPIPRAZOLE | 30MG | TABLET / ORAL | AB | 2019-02-21 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207105-001 | ARIPIPRAZOLE | 2MG | TABLET / ORAL | AB | 2019-02-21 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207105-002 | ARIPIPRAZOLE | 5MG | TABLET / ORAL | AB | 2019-02-21 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207105-003 | ARIPIPRAZOLE | 10MG | TABLET / ORAL | AB | 2019-02-21 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207105-004 | ARIPIPRAZOLE | 15MG | TABLET / ORAL | AB | 2019-02-21 | b8a1b40f171c… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A207105-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A207105-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A207105-003 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A207105-004 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A207105-005 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A207105-006 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A207105-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A207105-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A207105-003 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A207105-004 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A207105-005 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A207105-006 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A207105-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A207105-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A207105-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A207105-004 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A207105-005 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A207105-006 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207105-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207105-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207105-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207105-004 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207105-005 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207105-006 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A207105-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A207105-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A207105-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A207105-004 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A207105-005 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A207105-006 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207105-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207105-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207105-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207105-004 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207105-005 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207105-006 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207105-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207105-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207105-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207105-004 | AB | 1 | b8a1b40f171c… |
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
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ARIPIPRAZOLE | 10 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 82VFR53I78 | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 349545 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 50214c47-2ea3-b373-e063-6394a90aad23 | Available on FDA.report |
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. | 1d593ada-256d-4dec-9a26-2a6a67d97205 | 2026-07-31 | Boxed warning, Warnings, Adverse reactions | 207105 ANDA207105 |
| Aripiprazole | ARIPIPRAZOLE | REMEDYREPACK INC. | bc3fde41-2f24-44e2-815d-15fe55bd68b3 | 2026-07-30 | Boxed warning, Warnings, Adverse reactions | 207105 ANDA207105 |
| Aripiprazole | ARIPIPRAZOLE | REMEDYREPACK INC. | 506fa28f-6f98-4632-bce8-72a9cb507c90 | 2026-07-29 | Boxed warning, Warnings, Adverse reactions | 207105 ANDA207105 |
| Aripiprazole | ARIPIPRAZOLE | REMEDYREPACK INC. | f713c38e-cc49-4243-96b9-32d5dbbcf9cb | 2026-07-29 | Boxed warning, Warnings, Adverse reactions | 207105 ANDA207105 |
| Aripiprazole | ARIPIPRAZOLE | Coupler LLC | 55f3a705-9412-0f88-e063-6294a90a2b53 | 2026-07-06 | Boxed warning, Warnings, Adverse reactions | 207105 ANDA207105 |
| Aripiprazole | ARIPIPRAZOLE | Coupler LLC | 55f446b0-caa2-aca8-e063-6294a90af441 | 2026-07-06 | Boxed warning, Warnings, Adverse reactions | 207105 ANDA207105 |
| Aripiprazole | ARIPIPRAZOLE | Coupler LLC | 52bbfc8f-fa17-839e-e063-6394a90a6316 | 2026-05-26 | Boxed warning, Warnings, Adverse reactions | 207105 ANDA207105 |
| Aripiprazole | ARIPIPRAZOLE | Coupler LLC | 50214c47-2ea3-b373-e063-6394a90aad23 | 2026-04-23 | Boxed warning, Warnings, Adverse reactions | 207105 ANDA207105 67046-0492 |
| Aripiprazole | ARIPIPRAZOLE | REMEDYREPACK INC. | 6f580e75-61ab-4c7b-bb3f-f027a9603f84 | 2026-04-03 | Boxed warning, Warnings, Adverse reactions | 207105 ANDA207105 |
| Aripiprazole | ARIPIPRAZOLE | REMEDYREPACK INC. | 433cdc7d-465a-4ad4-bd84-cabd37e15f51 | 2026-03-19 | Boxed warning, Warnings, Adverse reactions | 207105 ANDA207105 |
| Aripiprazole | ARIPIPRAZOLE | Bryant Ranch Prepack | ff8dc838-ca1a-49d3-8938-5ae645574a75 | 2026-03-05 | Boxed warning, Warnings, Adverse reactions | 207105 ANDA207105 |
| Aripiprazole | ARIPIPRAZOLE | Bryant Ranch Prepack | 1e8d889e-126b-4627-a2cc-34f2d35a5d67 | 2026-01-28 | Boxed warning, Warnings, Adverse reactions | 207105 ANDA207105 |
| Aripiprazole | ARIPIPRAZOLE | Bryant Ranch Prepack | 1ef9e44f-5672-47c2-97e9-286e1b84417d | 2026-01-28 | Boxed warning, Warnings, Adverse reactions | 207105 ANDA207105 |
| Aripiprazole | ARIPIPRAZOLE | Bryant Ranch Prepack | 4bda6f17-d87c-4009-b329-99275c56106f | 2026-01-27 | Boxed warning, Warnings, Adverse reactions | 207105 ANDA207105 |
| Aripiprazole | ARIPIPRAZOLE | Bryant Ranch Prepack | fb40b669-4e37-4087-8fb1-3ac140543602 | 2026-01-27 | Boxed warning, Warnings, Adverse reactions | 207105 ANDA207105 |
| Aripiprazole | ARIPIPRAZOLE | A-S Medication Solutions | 554db933-aa80-4685-bcd5-58c84571c19c | 2026-01-06 | Boxed warning, Warnings, Adverse reactions | 207105 ANDA207105 |
| Aripiprazole | ARIPIPRAZOLE | Ascend Laboratories, LLC | c7040fef-96a7-4429-9a8e-ec3ab17a8019 | 2025-10-01 | Boxed warning, Warnings, Adverse reactions | 207105 ANDA207105 |
| Aripiprazole | ARIPIPRAZOLE | Direct_Rx | facdb9a9-612f-e59a-e053-6394a90a1fa7 | 2025-01-22 | Boxed warning, Warnings, Adverse reactions | 207105 ANDA207105 |
| Aripiprazole | ARIPIPRAZOLE | Direct_Rx | fcea91c3-e428-8991-e053-6394a90a099d | 2025-01-22 | Boxed warning, Warnings, Adverse reactions | 207105 ANDA207105 |
| Aripiprazole | ARIPIPRAZOLE | Preferred Pharmaceuticals Inc. | 34127431-6ad7-402f-bc22-1429c55d921c | 2025-01-03 | Boxed warning, Warnings, Adverse reactions | 207105 ANDA207105 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 67046-0492-3 | 67046049203 | 30 TABLET in 1 BLISTER PACK (67046-0492-3) | 30 tablet | 2026-04-23 | No | No | Current |