Rexulti
- Product NDC
- 70518-3548
- Requested package NDC
- 70518-3548-0
- 11-digit product format
- 705183548
- Labeler code
- 70518
- Product ID
- 70518-3548_502002a4-924a-5370-e063-6394a90a9717
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- brexpiprazole
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- NDA205422
- Marketing category
- NDA
- Marketing start
- 2022-10-03
- Substance
- BREXPIPRAZOLE
- Active strength
- 2 mg/1
- Pharmacologic classes
- Atypical Antipsychotic [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
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 package | package | 70518-3548 | 70518-3548-0 | D | Discontinued by firm | 2026-08-11 |
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 | Snapshot | Source SHA-256 |
|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | ad56d346431e… | cc804d4bbf1e… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N205422-001 | REXULTI | BREXPIPRAZOLE | 0.25MG | TABLET / ORAL | AB | RLD | 2015-07-10 |
| N205422-002 | REXULTI | BREXPIPRAZOLE | 0.5MG | TABLET / ORAL | AB | RLD | 2015-07-10 |
| N205422-003 | REXULTI | BREXPIPRAZOLE | 1MG | TABLET / ORAL | AB | RLD | 2015-07-10 |
| N205422-004 | REXULTI | BREXPIPRAZOLE | 2MG | TABLET / ORAL | AB | RLD, RS | 2015-07-10 |
| N205422-005 | REXULTI | BREXPIPRAZOLE | 3MG | TABLET / ORAL | AB | RLD | 2015-07-10 |
| N205422-006 | REXULTI | BREXPIPRAZOLE | 4MG | TABLET / ORAL | AB | RLD | 2015-07-10 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N205422-001 | AB |
| N205422-002 | AB |
| N205422-003 | AB |
| N205422-004 | AB |
| N205422-005 | AB |
| N205422-006 | AB |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N205422-001 | 8349840 | 2026-04-12 | U-1529 | Drug product | 2015-07-17 |
| N205422-001 | 8618109 | 2026-04-12 | U-3281 | 2015-07-17 | |
| N205422-001 | 8618109 | 2026-04-12 | U-543 | 2015-07-17 | |
| N205422-001 | 9839637 | 2026-04-12 | U-1529 | Drug product | 2018-01-09 |
| N205422-001 | 9839637 | 2026-04-12 | U-3281 | Drug product | 2018-01-09 |
| N205422-001 | 9839637 | 2026-04-12 | U-543 | Drug product | 2018-01-09 |
| N205422-001 | 8349840*PED | 2026-10-12 | Pediatric extension | ||
| N205422-001 | 8618109*PED | 2026-10-12 | Pediatric extension | ||
| N205422-001 | 9839637*PED | 2026-10-12 | Pediatric extension | ||
| N205422-001 | RE48059 | 2028-12-23 | Drug substance | 2020-07-20 | |
| N205422-001 | RE48059*PED | 2029-06-23 | Pediatric extension | ||
| N205422-001 | 10307419 | 2032-10-12 | Drug product | 2019-06-14 | |
| N205422-001 | 10307419*PED | 2033-04-12 | Pediatric extension | ||
| N205422-002 | 8349840 | 2026-04-12 | U-1529 | Drug product | 2015-07-17 |
| N205422-002 | 8618109 | 2026-04-12 | U-3281 | 2015-07-17 | |
| N205422-002 | 8618109 | 2026-04-12 | U-543 | 2015-07-17 | |
| N205422-002 | 9839637 | 2026-04-12 | U-1529 | Drug product | 2018-01-09 |
| N205422-002 | 9839637 | 2026-04-12 | U-3281 | Drug product | 2018-01-09 |
| N205422-002 | 9839637 | 2026-04-12 | U-543 | Drug product | 2018-01-09 |
| N205422-002 | 8349840*PED | 2026-10-12 | Pediatric extension | ||
| N205422-002 | 8618109*PED | 2026-10-12 | Pediatric extension | ||
| N205422-002 | 9839637*PED | 2026-10-12 | Pediatric extension | ||
| N205422-002 | RE48059 | 2028-12-23 | Drug substance | 2020-07-20 | |
| N205422-002 | RE48059*PED | 2029-06-23 | Pediatric extension | ||
| N205422-002 | 10307419 | 2032-10-12 | Drug product | 2019-06-14 | |
| N205422-002 | 10307419*PED | 2033-04-12 | Pediatric extension | ||
| N205422-003 | 8349840 | 2026-04-12 | U-1529 | Drug product | 2015-07-23 |
| N205422-003 | 8618109 | 2026-04-12 | U-3281 | 2015-07-23 | |
| N205422-003 | 8618109 | 2026-04-12 | U-543 | 2015-07-23 | |
| N205422-003 | 9839637 | 2026-04-12 | U-1529 | Drug product | 2018-01-09 |
| N205422-003 | 9839637 | 2026-04-12 | U-3281 | Drug product | 2018-01-09 |
| N205422-003 | 9839637 | 2026-04-12 | U-543 | Drug product | 2018-01-09 |
| N205422-003 | 8349840*PED | 2026-10-12 | Pediatric extension | ||
| N205422-003 | 8618109*PED | 2026-10-12 | Pediatric extension | ||
| N205422-003 | 9839637*PED | 2026-10-12 | Pediatric extension | ||
| N205422-003 | RE48059 | 2028-12-23 | Drug substance | 2020-07-20 | |
| N205422-003 | RE48059*PED | 2029-06-23 | Pediatric extension | ||
| N205422-003 | 10307419 | 2032-10-12 | Drug product | 2019-06-14 | |
| N205422-003 | 10307419*PED | 2033-04-12 | Pediatric extension | ||
| N205422-004 | 8349840 | 2026-04-12 | U-1529 | Drug product | 2015-07-23 |
| N205422-004 | 8618109 | 2026-04-12 | U-3281 | 2015-07-23 | |
| N205422-004 | 8618109 | 2026-04-12 | U-543 | 2015-07-23 | |
| N205422-004 | 9839637 | 2026-04-12 | U-1529 | Drug product | 2018-01-09 |
| N205422-004 | 9839637 | 2026-04-12 | U-3281 | Drug product | 2018-01-09 |
| N205422-004 | 9839637 | 2026-04-12 | U-543 | Drug product | 2018-01-09 |
| N205422-004 | 8349840*PED | 2026-10-12 | Pediatric extension | ||
| N205422-004 | 8618109*PED | 2026-10-12 | Pediatric extension | ||
| N205422-004 | 9839637*PED | 2026-10-12 | Pediatric extension | ||
| N205422-004 | RE48059 | 2028-12-23 | Drug substance | 2020-07-20 | |
| N205422-004 | RE48059*PED | 2029-06-23 | Pediatric extension | ||
| N205422-004 | 10307419 | 2032-10-12 | Drug product | 2019-06-14 | |
| N205422-004 | 10307419*PED | 2033-04-12 | Pediatric extension | ||
| N205422-005 | 8349840 | 2026-04-12 | U-1529 | Drug product | 2015-07-23 |
| N205422-005 | 8618109 | 2026-04-12 | U-3281 | 2015-07-23 | |
| N205422-005 | 8618109 | 2026-04-12 | U-543 | 2015-07-23 | |
| N205422-005 | 9839637 | 2026-04-12 | U-1529 | Drug product | 2018-01-09 |
| N205422-005 | 9839637 | 2026-04-12 | U-3281 | Drug product | 2018-01-09 |
| N205422-005 | 9839637 | 2026-04-12 | U-543 | Drug product | 2018-01-09 |
| N205422-005 | 8349840*PED | 2026-10-12 | Pediatric extension | ||
| N205422-005 | 8618109*PED | 2026-10-12 | Pediatric extension | ||
| N205422-005 | 9839637*PED | 2026-10-12 | Pediatric extension | ||
| N205422-005 | RE48059 | 2028-12-23 | Drug substance | 2020-07-20 | |
| N205422-005 | RE48059*PED | 2029-06-23 | Pediatric extension | ||
| N205422-005 | 10307419 | 2032-10-12 | Drug product | 2019-06-14 | |
| N205422-005 | 10307419*PED | 2033-04-12 | Pediatric extension | ||
| N205422-006 | 8349840 | 2026-04-12 | U-1529 | Drug product | 2015-07-23 |
| N205422-006 | 8618109 | 2026-04-12 | U-3281 | 2015-07-23 | |
| N205422-006 | 8618109 | 2026-04-12 | U-543 | 2015-07-23 | |
| N205422-006 | 9839637 | 2026-04-12 | U-1529 | Drug product | 2018-01-09 |
| N205422-006 | 9839637 | 2026-04-12 | U-3281 | Drug product | 2018-01-09 |
| N205422-006 | 9839637 | 2026-04-12 | U-543 | Drug product | 2018-01-09 |
| N205422-006 | 8349840*PED | 2026-10-12 | Pediatric extension | ||
| N205422-006 | 8618109*PED | 2026-10-12 | Pediatric extension | ||
| N205422-006 | 9839637*PED | 2026-10-12 | Pediatric extension | ||
| N205422-006 | RE48059 | 2028-12-23 | Drug substance | 2020-07-20 | |
| N205422-006 | RE48059*PED | 2029-06-23 | Pediatric extension |
Orange Book exclusivity#
| Application-product | Exclusivity code | Expiration |
|---|---|---|
| N205422-001 | I-913 | 2026-05-10 |
| N205422-001 | PED | 2026-11-10 |
| N205422-001 | M-14 | 2027-05-08 |
| N205422-001 | PED | 2027-11-08 |
| N205422-001 | M-315 | 2028-05-09 |
| N205422-002 | I-913 | 2026-05-10 |
| N205422-002 | PED | 2026-11-10 |
| N205422-002 | M-14 | 2027-05-08 |
| N205422-002 | PED | 2027-11-08 |
| N205422-002 | M-315 | 2028-05-09 |
| N205422-003 | I-913 | 2026-05-10 |
| N205422-003 | PED | 2026-11-10 |
| N205422-003 | M-14 | 2027-05-08 |
| N205422-003 | PED | 2027-11-08 |
| N205422-003 | M-315 | 2028-05-09 |
| N205422-004 | I-913 | 2026-05-10 |
| N205422-004 | PED | 2026-11-10 |
| N205422-004 | M-14 | 2027-05-08 |
| N205422-004 | PED | 2027-11-08 |
| N205422-004 | M-315 | 2028-05-09 |
| N205422-005 | I-913 | 2026-05-10 |
| N205422-005 | PED | 2026-11-10 |
| N205422-005 | M-14 | 2027-05-08 |
| N205422-005 | PED | 2027-11-08 |
| N205422-005 | M-315 | 2028-05-09 |
| N205422-006 | I-913 | 2026-05-10 |
| N205422-006 | PED | 2026-11-10 |
| N205422-006 | M-14 | 2027-05-08 |
| N205422-006 | PED | 2027-11-08 |
| N205422-006 | M-315 | 2028-05-09 |
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 | N205422-001 | REXULTI | 0.25MG | TABLET / ORAL | AB | RLD | 2015-07-10 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N205422-002 | REXULTI | 0.5MG | TABLET / ORAL | AB | RLD | 2015-07-10 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N205422-003 | REXULTI | 1MG | TABLET / ORAL | AB | RLD | 2015-07-10 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N205422-004 | REXULTI | 2MG | TABLET / ORAL | AB | RLD, RS | 2015-07-10 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N205422-005 | REXULTI | 3MG | TABLET / ORAL | AB | RLD | 2015-07-10 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N205422-006 | REXULTI | 4MG | TABLET / ORAL | AB | RLD | 2015-07-10 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N205422-001 | REXULTI | 0.25MG | TABLET / ORAL | AB | RLD | 2015-07-10 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N205422-002 | REXULTI | 0.5MG | TABLET / ORAL | AB | RLD | 2015-07-10 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N205422-003 | REXULTI | 1MG | TABLET / ORAL | AB | RLD | 2015-07-10 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N205422-004 | REXULTI | 2MG | TABLET / ORAL | AB | RLD, RS | 2015-07-10 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N205422-005 | REXULTI | 3MG | TABLET / ORAL | AB | RLD | 2015-07-10 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N205422-006 | REXULTI | 4MG | TABLET / ORAL | AB | RLD | 2015-07-10 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N205422-001 | REXULTI | 0.25MG | TABLET / ORAL | AB | RLD | 2015-07-10 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N205422-002 | REXULTI | 0.5MG | TABLET / ORAL | AB | RLD | 2015-07-10 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N205422-003 | REXULTI | 1MG | TABLET / ORAL | AB | RLD | 2015-07-10 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N205422-004 | REXULTI | 2MG | TABLET / ORAL | AB | RLD, RS | 2015-07-10 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N205422-005 | REXULTI | 3MG | TABLET / ORAL | AB | RLD | 2015-07-10 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N205422-006 | REXULTI | 4MG | TABLET / ORAL | AB | RLD | 2015-07-10 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N205422-001 | REXULTI | 0.25MG | TABLET / ORAL | AB | RLD | 2015-07-10 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N205422-002 | REXULTI | 0.5MG | TABLET / ORAL | AB | RLD | 2015-07-10 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N205422-003 | REXULTI | 1MG | TABLET / ORAL | AB | RLD | 2015-07-10 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N205422-004 | REXULTI | 2MG | TABLET / ORAL | AB | RLD, RS | 2015-07-10 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N205422-005 | REXULTI | 3MG | TABLET / ORAL | AB | RLD | 2015-07-10 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N205422-006 | REXULTI | 4MG | TABLET / ORAL | AB | RLD | 2015-07-10 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N205422-001 | REXULTI | 0.25MG | TABLET / ORAL | AB | RLD | 2015-07-10 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N205422-002 | REXULTI | 0.5MG | TABLET / ORAL | AB | RLD | 2015-07-10 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N205422-003 | REXULTI | 1MG | TABLET / ORAL | AB | RLD | 2015-07-10 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N205422-004 | REXULTI | 2MG | TABLET / ORAL | AB | RLD, RS | 2015-07-10 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N205422-005 | REXULTI | 3MG | TABLET / ORAL | AB | RLD | 2015-07-10 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N205422-006 | REXULTI | 4MG | TABLET / ORAL | AB | RLD | 2015-07-10 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N205422-001 | REXULTI | 0.25MG | TABLET / ORAL | RLD | 2015-07-10 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N205422-002 | REXULTI | 0.5MG | TABLET / ORAL | RLD | 2015-07-10 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N205422-003 | REXULTI | 1MG | TABLET / ORAL | RLD | 2015-07-10 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N205422-004 | REXULTI | 2MG | TABLET / ORAL | RLD, RS | 2015-07-10 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N205422-005 | REXULTI | 3MG | TABLET / ORAL | RLD | 2015-07-10 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N205422-006 | REXULTI | 4MG | TABLET / ORAL | RLD | 2015-07-10 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N205422-001 | REXULTI | 0.25MG | TABLET / ORAL | RLD | 2015-07-10 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N205422-002 | REXULTI | 0.5MG | TABLET / ORAL | RLD | 2015-07-10 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N205422-003 | REXULTI | 1MG | TABLET / ORAL | RLD | 2015-07-10 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N205422-004 | REXULTI | 2MG | TABLET / ORAL | RLD, RS | 2015-07-10 | 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 | N205422-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N205422-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N205422-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N205422-004 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N205422-005 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N205422-006 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N205422-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N205422-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N205422-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N205422-004 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N205422-005 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N205422-006 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N205422-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N205422-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N205422-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N205422-004 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N205422-005 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N205422-006 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N205422-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N205422-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N205422-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N205422-004 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N205422-005 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N205422-006 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N205422-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N205422-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N205422-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N205422-004 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N205422-005 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N205422-006 | AB | 1 | b8a1b40f171c… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N205422-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N205422-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N205422-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N205422-004 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N205422-005 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N205422-006 | AB | 1 | 5bbf6a4d5a75… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N205422-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N205422-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N205422-003 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N205422-004 | AB | 1 | 79d66fd596c7… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N205422-001 | 7888362 | 2026-04-12 | Drug substance, Delist requested | 2015-07-17 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N205422-001 | 8349840 | 2026-04-12 | U-1529 | Drug product | 2015-07-17 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N205422-001 | 8618109 | 2026-04-12 | U-543 | 2015-07-17 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N205422-001 | 8618109 | 2026-04-12 | U-3281 | 2015-07-17 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N205422-001 | 9839637 | 2026-04-12 | U-1529 | Drug product | 2018-01-09 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N205422-001 | 9839637 | 2026-04-12 | U-3281 | Drug product | 2018-01-09 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N205422-001 | 9839637 | 2026-04-12 | U-543 | Drug product | 2018-01-09 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N205422-001 | 7888362*PED | 2026-10-12 | Pediatric extension | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N205422-001 | 8349840*PED | 2026-10-12 | Pediatric extension | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N205422-001 | 8618109*PED | 2026-10-12 | Pediatric extension | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N205422-001 | 9839637*PED | 2026-10-12 | Pediatric extension | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N205422-001 | RE48059 | 2028-12-23 | Drug substance | 2020-07-20 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N205422-001 | RE48059*PED | 2029-06-23 | Pediatric extension | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N205422-001 | 10307419 | 2032-10-12 | Drug product | 2019-06-14 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N205422-001 | 10307419*PED | 2033-04-12 | Pediatric extension | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N205422-002 | 7888362 | 2026-04-12 | Drug substance, Delist requested | 2015-07-17 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N205422-002 | 8349840 | 2026-04-12 | U-1529 | Drug product | 2015-07-17 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N205422-002 | 8618109 | 2026-04-12 | U-543 | 2015-07-17 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N205422-002 | 8618109 | 2026-04-12 | U-3281 | 2015-07-17 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N205422-002 | 9839637 | 2026-04-12 | U-543 | Drug product | 2018-01-09 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N205422-002 | 9839637 | 2026-04-12 | U-1529 | Drug product | 2018-01-09 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N205422-002 | 9839637 | 2026-04-12 | U-3281 | Drug product | 2018-01-09 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N205422-002 | 7888362*PED | 2026-10-12 | Pediatric extension | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N205422-002 | 8349840*PED | 2026-10-12 | Pediatric extension | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N205422-002 | 8618109*PED | 2026-10-12 | Pediatric extension | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N205422-002 | 9839637*PED | 2026-10-12 | Pediatric extension | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N205422-002 | RE48059 | 2028-12-23 | Drug substance | 2020-07-20 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N205422-002 | RE48059*PED | 2029-06-23 | Pediatric extension | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N205422-002 | 10307419 | 2032-10-12 | Drug product | 2019-06-14 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N205422-002 | 10307419*PED | 2033-04-12 | Pediatric extension | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N205422-003 | 7888362 | 2026-04-12 | Drug substance, Delist requested | 2015-07-23 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N205422-003 | 8349840 | 2026-04-12 | U-1529 | Drug product | 2015-07-23 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N205422-003 | 8618109 | 2026-04-12 | U-543 | 2015-07-23 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N205422-003 | 8618109 | 2026-04-12 | U-3281 | 2015-07-23 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N205422-003 | 9839637 | 2026-04-12 | U-1529 | Drug product | 2018-01-09 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N205422-003 | 9839637 | 2026-04-12 | U-543 | Drug product | 2018-01-09 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N205422-003 | 9839637 | 2026-04-12 | U-3281 | Drug product | 2018-01-09 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N205422-003 | 7888362*PED | 2026-10-12 | Pediatric extension | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N205422-003 | 8349840*PED | 2026-10-12 | Pediatric extension | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N205422-003 | 8618109*PED | 2026-10-12 | Pediatric extension | 011fe1cb6892… |
Observed Orange Book exclusivity history#
| Captured | Edition | Application-product | Exclusivity code | Expiration | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N205422-001 | I-913 | 2026-05-10 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N205422-001 | PED | 2026-11-10 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N205422-001 | M-14 | 2027-05-08 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N205422-001 | PED | 2027-11-08 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N205422-001 | M-315 | 2028-05-09 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N205422-002 | I-913 | 2026-05-10 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N205422-002 | PED | 2026-11-10 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N205422-002 | M-14 | 2027-05-08 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N205422-002 | PED | 2027-11-08 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N205422-002 | M-315 | 2028-05-09 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N205422-003 | I-913 | 2026-05-10 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N205422-003 | PED | 2026-11-10 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N205422-003 | M-14 | 2027-05-08 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N205422-003 | PED | 2027-11-08 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N205422-003 | M-315 | 2028-05-09 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N205422-004 | I-913 | 2026-05-10 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N205422-004 | PED | 2026-11-10 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N205422-004 | M-14 | 2027-05-08 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N205422-004 | PED | 2027-11-08 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N205422-004 | M-315 | 2028-05-09 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N205422-005 | I-913 | 2026-05-10 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N205422-005 | PED | 2026-11-10 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N205422-005 | M-14 | 2027-05-08 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N205422-005 | PED | 2027-11-08 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N205422-005 | M-315 | 2028-05-09 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N205422-006 | I-913 | 2026-05-10 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N205422-006 | PED | 2026-11-10 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N205422-006 | M-14 | 2027-05-08 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N205422-006 | PED | 2027-11-08 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N205422-006 | M-315 | 2028-05-09 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N205422-001 | I-913 | 2026-05-10 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N205422-001 | PED | 2026-11-10 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N205422-001 | M-14 | 2027-05-08 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N205422-001 | PED | 2027-11-08 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N205422-001 | M-315 | 2028-05-09 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N205422-002 | I-913 | 2026-05-10 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N205422-002 | PED | 2026-11-10 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N205422-002 | M-14 | 2027-05-08 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N205422-002 | PED | 2027-11-08 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N205422-002 | M-315 | 2028-05-09 | 31067a03dcf5… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Rexulti
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| BREXPIPRAZOLE | 2 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 2J3YBM1K8C | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 6991c065-0f6e-433a-8f4f-796e0ece327f | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 4f98ce54-9f30-4e8a-8455-2d3e352e5314 | Product name | 2 | 20251106 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 70518-3548-0 | Rexulti | 30 in 1 BOTTLE | TABLET | 30 | 5 | |
| 70518-3548-0 | Rexulti | 1 in 1 CARTON | TABLET | 1 | 5 | |
| 70518-3548-1 | Rexulti | 50 in 1 BOX | TABLET | 50 | 5 | |
| 70518-3548-2 | Rexulti | 1 in 1 POUCH | TABLET | 1 | 5 |
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 |
|---|---|---|---|---|---|---|
| Rexulti | BREXPIPRAZOLE | REMEDYREPACK INC. | 6991c065-0f6e-433a-8f4f-796e0ece327f | 2026-06-02 | Boxed warning, Warnings, Adverse reactions | 205422 NDA205422 70518-3548-0 70518-3548 70518354800 |
| Rexulti | BREXPIPRAZOLE | Otsuka America Pharmaceutical, Inc. | 2d301358-6291-4ec1-bd87-37b4ad9bd850 | 2026-05-06 | Boxed warning, Warnings, Adverse reactions | 205422 NDA205422 |
| Rexulti | BREXPIPRAZOLE | REMEDYREPACK INC. | df891816-3fdb-4347-8bf0-c18bc40f1d70 | 2026-04-23 | Boxed warning, Warnings, Adverse reactions | 205422 NDA205422 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 70518-3548-0 | 70518354800 | 1 BOTTLE in 1 CARTON (70518-3548-0) > 30 TABLET in 1 BOTTLE | 1 bottle | 2022-10-03 | 0000-00-00 | No | No | Current |