ABILIFY
- Product NDC
- 63629-3387
- 11-digit product format
- 636293387
- Labeler code
- 63629
- Product ID
- 63629-3387_20f05298-1084-4bb6-88a6-ef225d995471
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ARIPIPRAZOLE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- NDA021436
- Marketing category
- NDA
- Marketing start
- 2002-11-15
- Marketing end
- 0000-00-00
- Substance
- ARIPIPRAZOLE
- Active strength
- 5 mg/1
- Pharmacologic classes
- Atypical Antipsychotic [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 63629-3387 | D | Discontinued by firm | 2026-10-05 | ||
| excluded package | package | 63629-3387 | 63629-3387-1 | D | Discontinued by firm | 2026-10-05 | |
| excluded package | package | 63629-3387 | 63629-3387-2 | D | Discontinued by firm | 2026-10-05 | |
| excluded package | package | 63629-3387 | 63629-3387-3 | D | Discontinued by firm | 2026-10-05 | |
| excluded package | package | 63629-3387 | 63629-3387-4 | D | Discontinued by firm | 2026-10-05 |
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Dataset | Scope | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 63629-3387-4 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 63629-3387-1 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 63629-3387-2 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 63629-3387-3 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 63629-3387-4 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 63629-3387-1 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 63629-3387-2 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 63629-3387-3 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 63629-3387-4 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 63629-3387-1 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 63629-3387-2 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 63629-3387-3 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 63629-3387-4 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 63629-3387-1 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 63629-3387-2 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 63629-3387-3 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 63629-3387-4 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 63629-3387-1 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 63629-3387-2 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 63629-3387-3 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 63629-3387-4 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 63629-3387-1 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 63629-3387-2 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 63629-3387-3 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 63629-3387-4 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 63629-3387-1 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 63629-3387-2 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 63629-3387-3 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 63629-3387-4 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 63629-3387-1 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 63629-3387-2 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 63629-3387-3 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 63629-3387-4 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 63629-3387-1 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 63629-3387-2 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 63629-3387-3 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded product | product | ad56d346431e… | cc804d4bbf1e… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 63629-3387-4 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 63629-3387-1 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 63629-3387-2 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 63629-3387-3 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded product | product | 367a005e9d99… | 383a685ebd0f… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 63629-3387-4 | 367a005e9d99… | 383a685ebd0f… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 63629-3387-1 | 367a005e9d99… | 383a685ebd0f… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 63629-3387-2 | 367a005e9d99… | 383a685ebd0f… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 63629-3387-3 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded product | product | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 63629-3387-4 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 63629-3387-1 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 63629-3387-2 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 63629-3387-3 | 557ba5c1ecfa… | 9c80585c8c6e… |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N021436-001 | ABILIFY | 10MG | TABLET / ORAL | AB | RLD, RS | 2002-11-15 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021436-002 | ABILIFY | 15MG | TABLET / ORAL | AB | RLD | 2002-11-15 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021436-003 | ABILIFY | 20MG | TABLET / ORAL | AB | RLD | 2002-11-15 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021436-004 | ABILIFY | 30MG | TABLET / ORAL | AB | RLD | 2002-11-15 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021436-005 | ABILIFY | 5MG | TABLET / ORAL | AB | RLD | 2002-11-15 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021436-006 | ABILIFY | 2MG | TABLET / ORAL | AB | RLD | 2002-11-15 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | N021436-001 | ABILIFY | 10MG | TABLET / ORAL | AB | RLD, RS | 2002-11-15 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N021436-002 | ABILIFY | 15MG | TABLET / ORAL | AB | RLD | 2002-11-15 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N021436-003 | ABILIFY | 20MG | TABLET / ORAL | AB | RLD | 2002-11-15 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N021436-004 | ABILIFY | 30MG | TABLET / ORAL | AB | RLD | 2002-11-15 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N021436-005 | ABILIFY | 5MG | TABLET / ORAL | AB | RLD | 2002-11-15 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N021436-006 | ABILIFY | 2MG | TABLET / ORAL | AB | RLD | 2002-11-15 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N021436-001 | ABILIFY | 10MG | TABLET / ORAL | AB | RLD, RS | 2002-11-15 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021436-002 | ABILIFY | 15MG | TABLET / ORAL | AB | RLD | 2002-11-15 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021436-003 | ABILIFY | 20MG | TABLET / ORAL | AB | RLD | 2002-11-15 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021436-004 | ABILIFY | 30MG | TABLET / ORAL | AB | RLD | 2002-11-15 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021436-005 | ABILIFY | 5MG | TABLET / ORAL | AB | RLD | 2002-11-15 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021436-006 | ABILIFY | 2MG | TABLET / ORAL | AB | RLD | 2002-11-15 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021436-001 | ABILIFY | 10MG | TABLET / ORAL | AB | RLD, RS | 2002-11-15 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021436-002 | ABILIFY | 15MG | TABLET / ORAL | AB | RLD | 2002-11-15 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021436-003 | ABILIFY | 20MG | TABLET / ORAL | AB | RLD | 2002-11-15 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021436-004 | ABILIFY | 30MG | TABLET / ORAL | AB | RLD | 2002-11-15 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021436-005 | ABILIFY | 5MG | TABLET / ORAL | AB | RLD | 2002-11-15 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021436-006 | ABILIFY | 2MG | TABLET / ORAL | AB | RLD | 2002-11-15 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N021436-001 | ABILIFY | 10MG | TABLET / ORAL | AB | RLD, RS | 2002-11-15 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021436-002 | ABILIFY | 15MG | TABLET / ORAL | AB | RLD | 2002-11-15 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021436-003 | ABILIFY | 20MG | TABLET / ORAL | AB | RLD | 2002-11-15 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021436-004 | ABILIFY | 30MG | TABLET / ORAL | AB | RLD | 2002-11-15 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021436-005 | ABILIFY | 5MG | TABLET / ORAL | AB | RLD | 2002-11-15 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021436-006 | ABILIFY | 2MG | TABLET / ORAL | AB | RLD | 2002-11-15 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021436-001 | ABILIFY | 10MG | TABLET / ORAL | AB | RLD, RS | 2002-11-15 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021436-002 | ABILIFY | 15MG | TABLET / ORAL | AB | RLD | 2002-11-15 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021436-003 | ABILIFY | 20MG | TABLET / ORAL | AB | RLD | 2002-11-15 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021436-004 | ABILIFY | 30MG | TABLET / ORAL | AB | RLD | 2002-11-15 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021436-005 | ABILIFY | 5MG | TABLET / ORAL | AB | RLD | 2002-11-15 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021436-006 | ABILIFY | 2MG | TABLET / ORAL | AB | RLD | 2002-11-15 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021436-001 | ABILIFY | 10MG | TABLET / ORAL | AB | RLD, RS | 2002-11-15 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021436-002 | ABILIFY | 15MG | TABLET / ORAL | AB | RLD | 2002-11-15 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021436-003 | ABILIFY | 20MG | TABLET / ORAL | AB | RLD | 2002-11-15 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021436-004 | ABILIFY | 30MG | TABLET / ORAL | AB | RLD | 2002-11-15 | 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 | N021436-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021436-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021436-003 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021436-004 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021436-005 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021436-006 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | N021436-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N021436-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N021436-003 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N021436-004 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N021436-005 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N021436-006 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N021436-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021436-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021436-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021436-004 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021436-005 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021436-006 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021436-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021436-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021436-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021436-004 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021436-005 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021436-006 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N021436-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021436-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021436-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021436-004 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021436-005 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021436-006 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021436-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021436-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021436-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021436-004 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021436-005 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021436-006 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021436-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021436-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021436-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021436-004 | AB | 1 | b8a1b40f171c… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N021436-001 | 9125939 | 2026-07-28 | U-1749 | 2015-10-07 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N021436-001 | 8759350 | 2027-03-02 | U-1529 | 2014-07-22 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N021436-002 | 9125939 | 2026-07-28 | U-1749 | 2015-10-07 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N021436-002 | 8759350 | 2027-03-02 | U-1529 | 2014-07-22 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N021436-003 | 9125939 | 2026-07-28 | U-1749 | 2015-10-07 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N021436-003 | 8759350 | 2027-03-02 | U-1529 | 2014-07-22 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N021436-004 | 9125939 | 2026-07-28 | U-1749 | 2015-10-07 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N021436-004 | 8759350 | 2027-03-02 | U-1529 | 2014-07-22 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N021436-005 | 9125939 | 2026-07-28 | U-1749 | 2015-10-07 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N021436-005 | 8759350 | 2027-03-02 | U-1529 | 2014-07-22 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N021436-006 | 9125939 | 2026-07-28 | U-1749 | 2015-10-07 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N021436-006 | 8759350 | 2027-03-02 | U-1529 | 2014-07-22 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N021436-001 | 9125939 | 2026-07-28 | U-1749 | 2015-10-07 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N021436-001 | 8759350 | 2027-03-02 | U-1529 | 2014-07-22 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N021436-002 | 9125939 | 2026-07-28 | U-1749 | 2015-10-07 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N021436-002 | 8759350 | 2027-03-02 | U-1529 | 2014-07-22 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N021436-003 | 9125939 | 2026-07-28 | U-1749 | 2015-10-07 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N021436-003 | 8759350 | 2027-03-02 | U-1529 | 2014-07-22 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N021436-004 | 9125939 | 2026-07-28 | U-1749 | 2015-10-07 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N021436-004 | 8759350 | 2027-03-02 | U-1529 | 2014-07-22 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N021436-005 | 9125939 | 2026-07-28 | U-1749 | 2015-10-07 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N021436-005 | 8759350 | 2027-03-02 | U-1529 | 2014-07-22 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N021436-006 | 9125939 | 2026-07-28 | U-1749 | 2015-10-07 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N021436-006 | 8759350 | 2027-03-02 | U-1529 | 2014-07-22 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021436-001 | 9125939 | 2026-07-28 | U-1749 | 2015-10-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021436-001 | 8759350 | 2027-03-02 | U-1529 | 2014-07-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021436-002 | 9125939 | 2026-07-28 | U-1749 | 2015-10-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021436-002 | 8759350 | 2027-03-02 | U-1529 | 2014-07-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021436-003 | 9125939 | 2026-07-28 | U-1749 | 2015-10-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021436-003 | 8759350 | 2027-03-02 | U-1529 | 2014-07-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021436-004 | 9125939 | 2026-07-28 | U-1749 | 2015-10-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021436-004 | 8759350 | 2027-03-02 | U-1529 | 2014-07-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021436-005 | 9125939 | 2026-07-28 | U-1749 | 2015-10-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021436-005 | 8759350 | 2027-03-02 | U-1529 | 2014-07-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021436-006 | 9125939 | 2026-07-28 | U-1749 | 2015-10-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021436-006 | 8759350 | 2027-03-02 | U-1529 | 2014-07-22 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021436-001 | 9125939 | 2026-07-28 | U-1749 | 2015-10-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021436-001 | 8759350 | 2027-03-02 | U-1529 | 2014-07-22 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021436-002 | 9125939 | 2026-07-28 | U-1749 | 2015-10-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021436-002 | 8759350 | 2027-03-02 | U-1529 | 2014-07-22 | 31067a03dcf5… |
Observed Orange Book exclusivity history#
| Captured | Edition | Application-product | Exclusivity code | Expiration | Source SHA-256 |
|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | N021436-001 | ODE-80 | 2021-12-12 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N021436-002 | ODE-80 | 2021-12-12 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N021436-003 | ODE-80 | 2021-12-12 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N021436-004 | ODE-80 | 2021-12-12 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N021436-005 | ODE-80 | 2021-12-12 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N021436-006 | ODE-80 | 2021-12-12 | 74a2ff9319b5… |
| 2021-12-28 21:50 UTC | 2021-12 | N021436-001 | ODE-80 | 2021-12-12 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | N021436-002 | ODE-80 | 2021-12-12 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | N021436-003 | ODE-80 | 2021-12-12 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | N021436-004 | ODE-80 | 2021-12-12 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | N021436-005 | ODE-80 | 2021-12-12 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | N021436-006 | ODE-80 | 2021-12-12 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N021436-001 | ODE-80 | 2021-12-12 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N021436-002 | ODE-80 | 2021-12-12 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N021436-003 | ODE-80 | 2021-12-12 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N021436-004 | ODE-80 | 2021-12-12 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N021436-005 | ODE-80 | 2021-12-12 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N021436-006 | ODE-80 | 2021-12-12 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | N021436-001 | ODE-80 | 2021-12-12 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | N021436-002 | ODE-80 | 2021-12-12 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | N021436-003 | ODE-80 | 2021-12-12 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | N021436-004 | ODE-80 | 2021-12-12 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | N021436-005 | ODE-80 | 2021-12-12 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | N021436-006 | ODE-80 | 2021-12-12 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | N021436-001 | ODE-80 | 2021-12-12 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | N021436-002 | ODE-80 | 2021-12-12 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | N021436-003 | ODE-80 | 2021-12-12 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | N021436-004 | ODE-80 | 2021-12-12 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | N021436-005 | ODE-80 | 2021-12-12 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | N021436-006 | ODE-80 | 2021-12-12 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | N021436-001 | ODE-80 | 2021-12-12 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | N021436-002 | ODE-80 | 2021-12-12 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | N021436-003 | ODE-80 | 2021-12-12 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | N021436-004 | ODE-80 | 2021-12-12 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | N021436-005 | ODE-80 | 2021-12-12 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | N021436-006 | ODE-80 | 2021-12-12 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | N021436-001 | ODE-80 | 2021-12-12 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | N021436-002 | ODE-80 | 2021-12-12 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | N021436-003 | ODE-80 | 2021-12-12 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | N021436-004 | ODE-80 | 2021-12-12 | 3f01610625f2… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 63629-3387-1 | EA - Each | 63629-3387 | f85ddd01-350d-44a3-a75a-3d5b45b79da8 | 1 | 2013-02-13 |
| 63629-3387-2 | EA - Each | 63629-3387 | 6d1b08ed-a415-4f3a-a85c-577ee73cf5ef | 1 | 2013-02-13 |
| 63629-3387-3 | EA - Each | 63629-3387 | a5406227-9543-4a13-ace6-27711a664d88 | 1 | 2013-02-13 |
| 63629-3387-4 | EA - Each | 63629-3387 | a7ecacda-0cfc-4485-b102-8bb8dd3fae35 | 1 | 2013-02-13 |
DailyMed Socrata Ingredients#
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 |
|---|---|---|---|---|---|---|
| ABILIFY | ARIPIPRAZOLE | Otsuka America Pharmaceutical, Inc. | c040bd1d-45b7-49f2-93ea-aed7220b30ac | 2025-01-29 | Boxed warning, Warnings, Adverse reactions | 021436 NDA021436 |