ABILIFY
- Product NDC
- 59148-011
- 11-digit product format
- 591480011
- Labeler code
- 59148
- Product ID
- 59148-011_1b189d15-798d-4bed-a93d-a543ed7abd81
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ARIPIPRAZOLE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Otsuka America Pharmaceutical, Inc.
- Application
- NDA021436
- Marketing category
- NDA
- Marketing start
- 2002-11-15
- Substance
- ARIPIPRAZOLE
- Active strength
- 30 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 |
|---|---|---|---|---|---|---|---|
| N021436-001 | ABILIFY | ARIPIPRAZOLE | 10MG | TABLET / ORAL | AB | RLD, RS | 2002-11-15 |
| N021436-002 | ABILIFY | ARIPIPRAZOLE | 15MG | TABLET / ORAL | AB | RLD | 2002-11-15 |
| N021436-003 | ABILIFY | ARIPIPRAZOLE | 20MG | TABLET / ORAL | AB | RLD | 2002-11-15 |
| N021436-004 | ABILIFY | ARIPIPRAZOLE | 30MG | TABLET / ORAL | AB | RLD | 2002-11-15 |
| N021436-005 | ABILIFY | ARIPIPRAZOLE | 5MG | TABLET / ORAL | AB | RLD | 2002-11-15 |
| N021436-006 | ABILIFY | ARIPIPRAZOLE | 2MG | TABLET / ORAL | AB | RLD | 2002-11-15 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N021436-001 | AB |
| N021436-002 | AB |
| N021436-003 | AB |
| N021436-004 | AB |
| N021436-005 | AB |
| N021436-006 | AB |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N021436-001 | 9125939 | 2026-07-28 | U-1749 | 2015-10-07 | |
| N021436-001 | 8759350 | 2027-03-02 | U-1529 | 2014-07-22 | |
| N021436-002 | 9125939 | 2026-07-28 | U-1749 | 2015-10-07 | |
| N021436-002 | 8759350 | 2027-03-02 | U-1529 | 2014-07-22 | |
| N021436-003 | 9125939 | 2026-07-28 | U-1749 | 2015-10-07 | |
| N021436-003 | 8759350 | 2027-03-02 | U-1529 | 2014-07-22 | |
| N021436-004 | 9125939 | 2026-07-28 | U-1749 | 2015-10-07 | |
| N021436-004 | 8759350 | 2027-03-02 | U-1529 | 2014-07-22 | |
| N021436-005 | 9125939 | 2026-07-28 | U-1749 | 2015-10-07 | |
| N021436-005 | 8759350 | 2027-03-02 | U-1529 | 2014-07-22 | |
| N021436-006 | 9125939 | 2026-07-28 | U-1749 | 2015-10-07 | |
| N021436-006 | 8759350 | 2027-03-02 | U-1529 | 2014-07-22 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-01 22:54:32 | 2026-06 | N021436-001 | ABILIFY | 10MG | TABLET / ORAL | AB | RLD, RS | 2002-11-15 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | N021436-002 | ABILIFY | 15MG | TABLET / ORAL | AB | RLD | 2002-11-15 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | N021436-003 | ABILIFY | 20MG | TABLET / ORAL | AB | RLD | 2002-11-15 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | N021436-004 | ABILIFY | 30MG | TABLET / ORAL | AB | RLD | 2002-11-15 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | N021436-005 | ABILIFY | 5MG | TABLET / ORAL | AB | RLD | 2002-11-15 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | N021436-006 | ABILIFY | 2MG | TABLET / ORAL | AB | RLD | 2002-11-15 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-01 22:54:32 | 2026-06 | N021436-001 | AB | 1 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | N021436-002 | AB | 1 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | N021436-003 | AB | 1 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | N021436-004 | AB | 1 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | N021436-005 | AB | 1 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | N021436-006 | AB | 1 | a50c72e98297… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2026-08-01 22:54:32 | 2026-06 | N021436-001 | 9125939 | 2026-07-28 | U-1749 | 2015-10-07 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | N021436-001 | 8759350 | 2027-03-02 | U-1529 | 2014-07-22 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | N021436-002 | 9125939 | 2026-07-28 | U-1749 | 2015-10-07 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | N021436-002 | 8759350 | 2027-03-02 | U-1529 | 2014-07-22 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | N021436-003 | 9125939 | 2026-07-28 | U-1749 | 2015-10-07 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | N021436-003 | 8759350 | 2027-03-02 | U-1529 | 2014-07-22 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | N021436-004 | 9125939 | 2026-07-28 | U-1749 | 2015-10-07 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | N021436-004 | 8759350 | 2027-03-02 | U-1529 | 2014-07-22 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | N021436-005 | 9125939 | 2026-07-28 | U-1749 | 2015-10-07 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | N021436-005 | 8759350 | 2027-03-02 | U-1529 | 2014-07-22 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | N021436-006 | 9125939 | 2026-07-28 | U-1749 | 2015-10-07 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | N021436-006 | 8759350 | 2027-03-02 | U-1529 | 2014-07-22 | a50c72e98297… |
openFDA label cross-check#
Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| ABILIFY | ARIPIPRAZOLE | Otsuka America Pharmaceutical, Inc. | c040bd1d-45b7-49f2-93ea-aed7220b30ac | 2025-01-29 | Boxed warning, Warnings, Adverse reactions | 021436 NDA021436 59148-011 |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- ABILIFY
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ARIPIPRAZOLE | 30 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 82VFR53I78 | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 349490 | Internal RxNorm lookup |
| 349545 | Internal RxNorm lookup |
| 349547 | Internal RxNorm lookup |
| 349553 | Internal RxNorm lookup |
| 352307 | Internal RxNorm lookup |
| 352308 | Internal RxNorm lookup |
| 352309 | Internal RxNorm lookup |
| 352310 | Internal RxNorm lookup |
| 402131 | Internal RxNorm lookup |
| 404602 | Internal RxNorm lookup |
| 602964 | Internal RxNorm lookup |
| 615172 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| c040bd1d-45b7-49f2-93ea-aed7220b30ac | 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 |
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 59148-011-13 | ABILIFY | 30 in 1 BOTTLE, PLASTIC | TABLET | 30 | 73 | |
| 59148-011-35 | ABILIFY | 100 in 1 BLISTER PACK | TABLET | 100 | 73 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 59148-011-13 | EA - Each | 59148-011 | 22c5d2db-72e9-4b8a-8517-1fede95dc8e8 | 1 | 2012-07-24 |
| 59148-011-35 | EA - Each | 59148-011 | ec6a8ba0-e6ba-4b73-82a4-a2d679f2d74b | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 59148-011-13 | 59148001113 | 30 TABLET in 1 BOTTLE, PLASTIC (59148-011-13) | 30 tablet | 2002-11-15 | 0000-00-00 | No | No | Current |
| 59148-011-35 | 59148001135 | 100 TABLET in 1 BLISTER PACK (59148-011-35) | 100 tablet | 2002-11-15 | 0000-00-00 | No | No | Current |