Aripiprazole
- Product NDC
- 62332-099
- 11-digit product format
- 623320099
- Labeler code
- 62332
- Product ID
- 62332-099_27cb5061-f64f-4328-9d1e-c18250dcb23a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Aripiprazole
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Alembic Pharmaceuticals Inc.
- Application
- ANDA202101
- Marketing category
- ANDA
- Marketing start
- 2016-07-07
- 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 |
|---|---|---|---|---|---|---|---|
| A202101-001 | ARIPIPRAZOLE | ARIPIPRAZOLE | 2MG | TABLET / ORAL | AB | 2015-04-28 | |
| A202101-002 | ARIPIPRAZOLE | ARIPIPRAZOLE | 5MG | TABLET / ORAL | AB | 2015-04-28 | |
| A202101-003 | ARIPIPRAZOLE | ARIPIPRAZOLE | 10MG | TABLET / ORAL | AB | 2015-04-28 | |
| A202101-004 | ARIPIPRAZOLE | ARIPIPRAZOLE | 15MG | TABLET / ORAL | AB | 2015-04-28 | |
| A202101-005 | ARIPIPRAZOLE | ARIPIPRAZOLE | 20MG | TABLET / ORAL | AB | 2015-04-28 | |
| A202101-006 | ARIPIPRAZOLE | ARIPIPRAZOLE | 30MG | TABLET / ORAL | AB | 2015-04-28 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A202101-001 | AB |
| A202101-002 | AB |
| A202101-003 | AB |
| A202101-004 | AB |
| A202101-005 | AB |
| A202101-006 | 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 | A202101-001 | ARIPIPRAZOLE | 2MG | TABLET / ORAL | AB | 2015-04-28 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A202101-002 | ARIPIPRAZOLE | 5MG | TABLET / ORAL | AB | 2015-04-28 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A202101-003 | ARIPIPRAZOLE | 10MG | TABLET / ORAL | AB | 2015-04-28 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A202101-004 | ARIPIPRAZOLE | 15MG | TABLET / ORAL | AB | 2015-04-28 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A202101-005 | ARIPIPRAZOLE | 20MG | TABLET / ORAL | AB | 2015-04-28 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A202101-006 | ARIPIPRAZOLE | 30MG | TABLET / ORAL | AB | 2015-04-28 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202101-001 | ARIPIPRAZOLE | 2MG | TABLET / ORAL | AB | 2015-04-28 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202101-002 | ARIPIPRAZOLE | 5MG | TABLET / ORAL | AB | 2015-04-28 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202101-003 | ARIPIPRAZOLE | 10MG | TABLET / ORAL | AB | 2015-04-28 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202101-004 | ARIPIPRAZOLE | 15MG | TABLET / ORAL | AB | 2015-04-28 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202101-005 | ARIPIPRAZOLE | 20MG | TABLET / ORAL | AB | 2015-04-28 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202101-006 | ARIPIPRAZOLE | 30MG | TABLET / ORAL | AB | 2015-04-28 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202101-001 | ARIPIPRAZOLE | 2MG | TABLET / ORAL | AB | 2015-04-28 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202101-002 | ARIPIPRAZOLE | 5MG | TABLET / ORAL | AB | 2015-04-28 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202101-003 | ARIPIPRAZOLE | 10MG | TABLET / ORAL | AB | 2015-04-28 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202101-004 | ARIPIPRAZOLE | 15MG | TABLET / ORAL | AB | 2015-04-28 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202101-005 | ARIPIPRAZOLE | 20MG | TABLET / ORAL | AB | 2015-04-28 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202101-006 | ARIPIPRAZOLE | 30MG | TABLET / ORAL | AB | 2015-04-28 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202101-001 | ARIPIPRAZOLE | 2MG | TABLET / ORAL | AB | 2015-04-28 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202101-002 | ARIPIPRAZOLE | 5MG | TABLET / ORAL | AB | 2015-04-28 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202101-003 | ARIPIPRAZOLE | 10MG | TABLET / ORAL | AB | 2015-04-28 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202101-004 | ARIPIPRAZOLE | 15MG | TABLET / ORAL | AB | 2015-04-28 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202101-005 | ARIPIPRAZOLE | 20MG | TABLET / ORAL | AB | 2015-04-28 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202101-006 | ARIPIPRAZOLE | 30MG | TABLET / ORAL | AB | 2015-04-28 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202101-001 | ARIPIPRAZOLE | 2MG | TABLET / ORAL | AB | 2015-04-28 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202101-002 | ARIPIPRAZOLE | 5MG | TABLET / ORAL | AB | 2015-04-28 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202101-003 | ARIPIPRAZOLE | 10MG | TABLET / ORAL | AB | 2015-04-28 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202101-004 | ARIPIPRAZOLE | 15MG | TABLET / ORAL | AB | 2015-04-28 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202101-005 | ARIPIPRAZOLE | 20MG | TABLET / ORAL | AB | 2015-04-28 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202101-006 | ARIPIPRAZOLE | 30MG | TABLET / ORAL | AB | 2015-04-28 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202101-001 | ARIPIPRAZOLE | 2MG | TABLET / ORAL | AB | 2015-04-28 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202101-002 | ARIPIPRAZOLE | 5MG | TABLET / ORAL | AB | 2015-04-28 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202101-003 | ARIPIPRAZOLE | 10MG | TABLET / ORAL | AB | 2015-04-28 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202101-004 | ARIPIPRAZOLE | 15MG | TABLET / ORAL | AB | 2015-04-28 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202101-005 | ARIPIPRAZOLE | 20MG | TABLET / ORAL | AB | 2015-04-28 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202101-006 | ARIPIPRAZOLE | 30MG | TABLET / ORAL | AB | 2015-04-28 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202101-001 | ARIPIPRAZOLE | 2MG | TABLET / ORAL | AB | 2015-04-28 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202101-002 | ARIPIPRAZOLE | 5MG | TABLET / ORAL | AB | 2015-04-28 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202101-003 | ARIPIPRAZOLE | 10MG | TABLET / ORAL | AB | 2015-04-28 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202101-004 | ARIPIPRAZOLE | 15MG | TABLET / ORAL | AB | 2015-04-28 | 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 | A202101-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A202101-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A202101-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A202101-004 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A202101-005 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A202101-006 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202101-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202101-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202101-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202101-004 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202101-005 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202101-006 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A202101-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A202101-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A202101-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A202101-004 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A202101-005 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A202101-006 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202101-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202101-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202101-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202101-004 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202101-005 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202101-006 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202101-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202101-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202101-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202101-004 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202101-005 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202101-006 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202101-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202101-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202101-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202101-004 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202101-005 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202101-006 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202101-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202101-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202101-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202101-004 | 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 |
|---|---|
| a10a5427-58b1-42dd-964c-3f8c78770534 | 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 |
|---|---|---|---|---|---|---|
| 62332-099-10 | Aripiprazole | 100 in 1 CARTON | TABLET | 100 | 19 | |
| 62332-099-30 | Aripiprazole | 30 in 1 BOTTLE | TABLET | 30 | 19 | |
| 62332-099-31 | Aripiprazole | 100 in 1 BOTTLE | TABLET | 100 | 19 | |
| 62332-099-71 | Aripiprazole | 500 in 1 BOTTLE | TABLET | 500 | 19 | |
| 62332-099-91 | Aripiprazole | 1000 in 1 BOTTLE | TABLET | 1000 | 19 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 62332-099-30 | EA - Each | 62332-099 | 119fc7f2-46f4-46b0-b8c8-c31fd0244248 | 1 | 2017-05-04 |
| 62332-099-31 | EA - Each | 62332-099 | b6a771ab-4701-429f-82ac-d0092ae8a7e7 | 1 | 2017-05-04 |
| 62332-099-71 | EA - Each | 62332-099 | e9124fae-7879-49a2-820e-c8dff3f3ad84 | 1 | 2024-04-05 |
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. | 119e3387-39a2-4fe5-904b-c2d008425c0a | 2026-07-22 | Boxed warning, Warnings, Adverse reactions | 202101 ANDA202101 |
| Aripiprazole | ARIPIPRAZOLE | REMEDYREPACK INC. | 99747897-22fe-4bee-9942-6349c0c8f6b0 | 2026-07-17 | Boxed warning, Warnings, Adverse reactions | 202101 ANDA202101 |
| Aripiprazole | ARIPIPRAZOLE | Coupler LLC | 56439ef6-a07e-34c9-e063-6294a90a77c3 | 2026-07-10 | Boxed warning, Warnings, Adverse reactions | 202101 ANDA202101 |
| Aripiprazole | ARIPIPRAZOLE | Coupler LLC | 52cc86ba-2c4f-1aba-e063-6294a90a844e | 2026-05-27 | Boxed warning, Warnings, Adverse reactions | 202101 ANDA202101 |
| Aripiprazole | ARIPIPRAZOLE | Coupler LLC | 512874e6-6d00-2623-e063-6394a90aa4bc | 2026-05-06 | Boxed warning, Warnings, Adverse reactions | 202101 ANDA202101 |
| Aripiprazole | ARIPIPRAZOLE | Preferred Pharmaceuticals Inc. | 02a4af27-c83c-4166-950c-7a1cb12d198d | 2026-03-05 | Boxed warning, Warnings, Adverse reactions | 202101 ANDA202101 |
| Aripiprazole | ARIPIPRAZOLE | Alembic Pharmaceuticals Inc. | a10a5427-58b1-42dd-964c-3f8c78770534 | 2025-06-25 | Boxed warning, Warnings, Adverse reactions | 202101 ANDA202101 62332-099 |
| Aripiprazole | ARIPIPRAZOLE | Alembic Pharmaceuticals Limited | 793fc904-2f11-4f97-a0ac-4d6910cac0f9 | 2023-01-27 | Boxed warning, Warnings, Adverse reactions | 202101 ANDA202101 |
DailyMed RxNorm Mappings#
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 62332-099-10 | 62332009910 | 100 TABLET in 1 CARTON (62332-099-10) | 100 tablet | 2016-07-07 | 0000-00-00 | No | No | Current |
| 62332-099-30 | 62332009930 | 30 TABLET in 1 BOTTLE (62332-099-30) | 30 tablet | 2016-07-07 | 0000-00-00 | No | No | Current |
| 62332-099-31 | 62332009931 | 100 TABLET in 1 BOTTLE (62332-099-31) | 100 tablet | 2016-07-07 | 0000-00-00 | No | No | Current |
| 62332-099-71 | 62332009971 | 500 TABLET in 1 BOTTLE (62332-099-71) | 500 tablet | 2016-07-07 | 0000-00-00 | No | No | Current |
| 62332-099-91 | 62332009991 | 1000 TABLET in 1 BOTTLE (62332-099-91) | 1000 tablet | 2016-07-07 | 0000-00-00 | No | No | Current |