ABILIFY
- Product NDC
- 59148-640
- 11-digit product format
- 591480640
- Labeler code
- 59148
- Product ID
- 59148-640_9e8f76af-6b2e-5349-e053-2a95a90adcdd
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ARIPIPRAZOLE
- Dosage form
- TABLET, ORALLY DISINTEGRATING
- Route
- ORAL
- Labeler
- Otsuka America Pharmaceutical, Inc.
- Application
- NDA021729
- Marketing category
- NDA
- Marketing start
- 2006-06-07
- Marketing end
- 0000-00-00
- Substance
- ARIPIPRAZOLE
- Active strength
- 10 mg/1
- Pharmacologic classes
- Atypical Antipsychotic [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2021-12-31
- 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 | 59148-640 | D | Discontinued by firm | 2026-10-05 | ||
| excluded package | package | 59148-640 | 59148-640-23 | 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 | 59148-640-23 | 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 | 59148-640-23 | 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 | 59148-640-23 | 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 | 59148-640-23 | 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 | 59148-640-23 | 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 | 59148-640-23 | 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 | 59148-640-23 | 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 | 59148-640-23 | 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 | 59148-640-23 | 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 | 59148-640-23 | 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 | 59148-640-23 | 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 | 59148-640-23 | 557ba5c1ecfa… | 9c80585c8c6e… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N021729-002 | ABILIFY | ARIPIPRAZOLE | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2006-06-07 | |
| N021729-003 | ABILIFY | ARIPIPRAZOLE | 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2006-06-07 | |
| N021729-004 | ABILIFY | ARIPIPRAZOLE | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2006-06-07 | |
| N021729-005 | ABILIFY | ARIPIPRAZOLE | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2006-06-07 |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N021729-002 | 9125939 | 2026-07-28 | U-1749 | 2015-10-07 | |
| N021729-002 | 8759350 | 2027-03-02 | U-1529 | 2014-07-22 | |
| N021729-003 | 9125939 | 2026-07-28 | U-1749 | 2015-10-07 | |
| N021729-003 | 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 | N021729-002 | ABILIFY | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2006-06-07 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N021729-003 | ABILIFY | 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2006-06-07 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N021729-004 | ABILIFY | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2006-06-07 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N021729-005 | ABILIFY | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2006-06-07 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N021729-002 | ABILIFY | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2006-06-07 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N021729-003 | ABILIFY | 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2006-06-07 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N021729-004 | ABILIFY | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2006-06-07 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N021729-005 | ABILIFY | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2006-06-07 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021729-002 | ABILIFY | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2006-06-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021729-003 | ABILIFY | 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2006-06-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021729-004 | ABILIFY | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2006-06-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021729-005 | ABILIFY | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2006-06-07 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021729-002 | ABILIFY | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2006-06-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021729-003 | ABILIFY | 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2006-06-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021729-004 | ABILIFY | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2006-06-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021729-005 | ABILIFY | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2006-06-07 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021729-002 | ABILIFY | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2006-06-07 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021729-003 | ABILIFY | 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2006-06-07 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021729-004 | ABILIFY | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2006-06-07 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021729-005 | ABILIFY | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2006-06-07 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021729-002 | ABILIFY | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2006-06-07 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021729-003 | ABILIFY | 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2006-06-07 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021729-004 | ABILIFY | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2006-06-07 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021729-005 | ABILIFY | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2006-06-07 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021729-002 | ABILIFY | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2006-06-07 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021729-003 | ABILIFY | 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2006-06-07 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021729-004 | ABILIFY | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2006-06-07 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021729-005 | ABILIFY | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2006-06-07 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021729-002 | ABILIFY | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2006-06-07 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021729-003 | ABILIFY | 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2006-06-07 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021729-004 | ABILIFY | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2006-06-07 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021729-005 | ABILIFY | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2006-06-07 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021729-002 | ABILIFY | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2006-06-07 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021729-003 | ABILIFY | 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2006-06-07 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021729-004 | ABILIFY | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2006-06-07 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021729-005 | ABILIFY | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2006-06-07 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021729-002 | ABILIFY | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2006-06-07 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021729-003 | ABILIFY | 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2006-06-07 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021729-004 | ABILIFY | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2006-06-07 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021729-005 | ABILIFY | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2006-06-07 | 5bbf6a4d5a75… |
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 | N021729-002 | 9125939 | 2026-07-28 | U-1749 | 2015-10-07 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N021729-002 | 8759350 | 2027-03-02 | U-1529 | 2014-07-22 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N021729-003 | 9125939 | 2026-07-28 | U-1749 | 2015-10-07 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N021729-003 | 8759350 | 2027-03-02 | U-1529 | 2014-07-22 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N021729-002 | 9125939 | 2026-07-28 | U-1749 | 2015-10-07 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N021729-002 | 8759350 | 2027-03-02 | U-1529 | 2014-07-22 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N021729-003 | 9125939 | 2026-07-28 | U-1749 | 2015-10-07 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N021729-003 | 8759350 | 2027-03-02 | U-1529 | 2014-07-22 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021729-002 | 9125939 | 2026-07-28 | U-1749 | 2015-10-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021729-002 | 8759350 | 2027-03-02 | U-1529 | 2014-07-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021729-003 | 9125939 | 2026-07-28 | U-1749 | 2015-10-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021729-003 | 8759350 | 2027-03-02 | U-1529 | 2014-07-22 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021729-002 | 9125939 | 2026-07-28 | U-1749 | 2015-10-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021729-002 | 8759350 | 2027-03-02 | U-1529 | 2014-07-22 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021729-003 | 9125939 | 2026-07-28 | U-1749 | 2015-10-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021729-003 | 8759350 | 2027-03-02 | U-1529 | 2014-07-22 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021729-002 | 9125939 | 2026-07-28 | U-1749 | 2015-10-07 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021729-002 | 8759350 | 2027-03-02 | U-1529 | 2014-07-22 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021729-003 | 9125939 | 2026-07-28 | U-1749 | 2015-10-07 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021729-003 | 8759350 | 2027-03-02 | U-1529 | 2014-07-22 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021729-002 | 9125939 | 2026-07-28 | U-1749 | 2015-10-07 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021729-002 | 8759350 | 2027-03-02 | U-1529 | 2014-07-22 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021729-003 | 9125939 | 2026-07-28 | U-1749 | 2015-10-07 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021729-003 | 8759350 | 2027-03-02 | U-1529 | 2014-07-22 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021729-002 | 9125939 | 2026-07-28 | U-1749 | 2015-10-07 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021729-002 | 8759350 | 2027-03-02 | U-1529 | 2014-07-22 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021729-003 | 9125939 | 2026-07-28 | U-1749 | 2015-10-07 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021729-003 | 8759350 | 2027-03-02 | U-1529 | 2014-07-22 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021729-002 | 8017615 | 2024-06-16 | Drug product | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021729-002 | 8017615*PED | 2024-12-16 | Pediatric extension | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021729-002 | 9125939 | 2026-07-28 | U-1749 | 2015-10-07 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021729-002 | 8759350 | 2027-03-02 | U-1529 | 2014-07-22 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021729-003 | 8017615 | 2024-06-16 | Drug product | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021729-003 | 8017615*PED | 2024-12-16 | Pediatric extension | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021729-003 | 9125939 | 2026-07-28 | U-1749 | 2015-10-07 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021729-003 | 8759350 | 2027-03-02 | U-1529 | 2014-07-22 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021729-004 | 8017615 | 2024-06-16 | Drug product | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021729-004 | 8017615*PED | 2024-12-16 | Pediatric extension | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021729-005 | 8017615 | 2024-06-16 | Drug product | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021729-005 | 8017615*PED | 2024-12-16 | Pediatric extension | 03ed91905a0d… |
Observed Orange Book exclusivity history#
| Captured | Edition | Application-product | Exclusivity code | Expiration | Source SHA-256 |
|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | N021729-002 | ODE-80 | 2021-12-12 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N021729-003 | ODE-80 | 2021-12-12 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N021729-004 | ODE-80 | 2021-12-12 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N021729-005 | ODE-80 | 2021-12-12 | 74a2ff9319b5… |
| 2021-12-28 21:50 UTC | 2021-12 | N021729-002 | ODE-80 | 2021-12-12 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | N021729-003 | ODE-80 | 2021-12-12 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | N021729-004 | ODE-80 | 2021-12-12 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | N021729-005 | ODE-80 | 2021-12-12 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N021729-002 | ODE-80 | 2021-12-12 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N021729-003 | ODE-80 | 2021-12-12 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N021729-004 | ODE-80 | 2021-12-12 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N021729-005 | ODE-80 | 2021-12-12 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | N021729-002 | ODE-80 | 2021-12-12 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | N021729-003 | ODE-80 | 2021-12-12 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | N021729-004 | ODE-80 | 2021-12-12 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | N021729-005 | ODE-80 | 2021-12-12 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | N021729-002 | ODE-80 | 2021-12-12 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | N021729-003 | ODE-80 | 2021-12-12 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | N021729-004 | ODE-80 | 2021-12-12 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | N021729-005 | ODE-80 | 2021-12-12 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | N021729-002 | ODE-80 | 2021-12-12 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | N021729-003 | ODE-80 | 2021-12-12 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | N021729-004 | ODE-80 | 2021-12-12 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | N021729-005 | ODE-80 | 2021-12-12 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | N021729-002 | ODE-80 | 2021-12-12 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | N021729-003 | ODE-80 | 2021-12-12 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | N021729-004 | ODE-80 | 2021-12-12 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | N021729-005 | ODE-80 | 2021-12-12 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | N021729-002 | ODE-80 | 2021-12-12 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | N021729-003 | ODE-80 | 2021-12-12 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | N021729-004 | ODE-80 | 2021-12-12 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | N021729-005 | ODE-80 | 2021-12-12 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | N021729-002 | ODE-80 | 2021-12-12 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | N021729-003 | ODE-80 | 2021-12-12 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | N021729-004 | ODE-80 | 2021-12-12 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | N021729-005 | ODE-80 | 2021-12-12 | ea99ee380514… |
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 |
|---|---|---|---|---|---|
| 59148-640-23 | EA - Each | 59148-640 | 526922c5-d917-49ec-929a-7d27be619bf1 | 1 | 2012-07-24 |