Myrbetriq
- Product NDC
- 70518-3158
- 11-digit product format
- 705183158
- Labeler code
- 70518
- Product ID
- 70518-3158_ee4f763d-bd7c-a027-e053-2a95a90a280b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- mirabegron
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- NDA202611
- Marketing category
- NDA
- Marketing start
- 2021-07-15
- Marketing end
- 0000-00-00
- Substance
- MIRABEGRON
- Active strength
- 25 mg/1
- Pharmacologic classes
- Adrenergic beta3-Agonists [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], beta3-Adrenergic Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- 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 | 70518-3158 | D | Discontinued by firm | 2026-08-17 | ||
| excluded package | package | 70518-3158 | 70518-3158-0 | D | Discontinued by firm | 2026-08-17 | |
| excluded package | package | 70518-3158 | 70518-3158-2 | D | Discontinued by firm | 2026-08-17 |
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 | 70518-3158-0 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 70518-3158-2 | 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 | 70518-3158-0 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 70518-3158-2 | 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 | 70518-3158-0 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 70518-3158-2 | 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 | 70518-3158-0 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 70518-3158-2 | 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 | 70518-3158-0 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 70518-3158-2 | 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 | 70518-3158-0 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 70518-3158-2 | 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 | 70518-3158-0 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 70518-3158-2 | 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 | 70518-3158-0 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 70518-3158-2 | 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 | 70518-3158-0 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 70518-3158-2 | 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 | 70518-3158-0 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 70518-3158-2 | 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 | 70518-3158-0 | 367a005e9d99… | 383a685ebd0f… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 70518-3158-2 | 367a005e9d99… | 383a685ebd0f… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N202611-001 | MYRBETRIQ | MIRABEGRON | 25MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2012-06-28 |
| N202611-002 | MYRBETRIQ | MIRABEGRON | 50MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2012-06-28 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N202611-001 | AB |
| N202611-002 | AB |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N202611-001 | 8772315 | 2028-10-30 | U-2300 | 2018-05-17 | |
| N202611-001 | 8772315*PED | 2029-04-30 | Pediatric extension | ||
| N202611-001 | 10842780 | 2029-09-28 | U-2996 | Drug product | 2020-12-11 |
| N202611-001 | 10842780 | 2029-09-28 | U-3670 | Drug product | 2020-12-11 |
| N202611-001 | 11707451 | 2029-09-28 | U-2996 | 2023-08-21 | |
| N202611-001 | 11707451 | 2029-09-28 | U-3670 | 2023-08-21 | |
| N202611-001 | 12059409 | 2029-09-28 | Drug product | 2024-08-28 | |
| N202611-001 | 12097189 | 2029-09-28 | U-2996 | 2024-10-02 | |
| N202611-001 | 12097189 | 2029-09-28 | U-3670 | 2024-10-02 | |
| N202611-001 | 10842780*PED | 2030-03-28 | Pediatric extension | ||
| N202611-001 | 11707451*PED | 2030-03-28 | Pediatric extension | ||
| N202611-001 | 12059409*PED | 2030-03-28 | Pediatric extension | ||
| N202611-001 | 12097189*PED | 2030-03-28 | Pediatric extension | ||
| N202611-002 | 8772315 | 2028-10-30 | U-2300 | 2018-05-17 | |
| N202611-002 | 8772315*PED | 2029-04-30 | Pediatric extension | ||
| N202611-002 | 10842780 | 2029-09-28 | U-2996 | Drug product | 2020-12-11 |
| N202611-002 | 10842780 | 2029-09-28 | U-3670 | Drug product | 2020-12-11 |
| N202611-002 | 11707451 | 2029-09-28 | U-2996 | 2023-08-21 | |
| N202611-002 | 11707451 | 2029-09-28 | U-3670 | 2023-08-21 | |
| N202611-002 | 12059409 | 2029-09-28 | Drug product | 2024-08-28 | |
| N202611-002 | 12097189 | 2029-09-28 | U-2996 | 2024-10-02 | |
| N202611-002 | 12097189 | 2029-09-28 | U-3670 | 2024-10-02 | |
| N202611-002 | 10842780*PED | 2030-03-28 | Pediatric extension | ||
| N202611-002 | 11707451*PED | 2030-03-28 | Pediatric extension | ||
| N202611-002 | 12059409*PED | 2030-03-28 | Pediatric extension | ||
| N202611-002 | 12097189*PED | 2030-03-28 | Pediatric extension |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | N202611-001 | MYRBETRIQ | 25MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2012-06-28 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N202611-002 | MYRBETRIQ | 50MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2012-06-28 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N202611-001 | MYRBETRIQ | 25MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2012-06-28 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N202611-002 | MYRBETRIQ | 50MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2012-06-28 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N202611-001 | MYRBETRIQ | 25MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2012-06-28 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N202611-002 | MYRBETRIQ | 50MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2012-06-28 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N202611-001 | MYRBETRIQ | 25MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2012-06-28 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N202611-002 | MYRBETRIQ | 50MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2012-06-28 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N202611-001 | MYRBETRIQ | 25MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2012-06-28 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N202611-002 | MYRBETRIQ | 50MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2012-06-28 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N202611-001 | MYRBETRIQ | 25MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2012-06-28 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N202611-002 | MYRBETRIQ | 50MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2012-06-28 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N202611-001 | MYRBETRIQ | 25MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2012-06-28 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N202611-002 | MYRBETRIQ | 50MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2012-06-28 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N202611-001 | MYRBETRIQ | 25MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2012-06-28 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N202611-002 | MYRBETRIQ | 50MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2012-06-28 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N202611-001 | MYRBETRIQ | 25MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2012-06-28 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N202611-002 | MYRBETRIQ | 50MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2012-06-28 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N202611-001 | MYRBETRIQ | 25MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2012-06-28 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N202611-002 | MYRBETRIQ | 50MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2012-06-28 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N202611-001 | MYRBETRIQ | 25MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2012-06-28 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N202611-002 | MYRBETRIQ | 50MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2012-06-28 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N202611-001 | MYRBETRIQ | 25MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2012-06-28 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N202611-002 | MYRBETRIQ | 50MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2012-06-28 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N202611-001 | MYRBETRIQ | 25MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2012-06-28 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N202611-002 | MYRBETRIQ | 50MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2012-06-28 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N202611-001 | MYRBETRIQ | 25MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2012-06-28 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N202611-002 | MYRBETRIQ | 50MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2012-06-28 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N202611-001 | MYRBETRIQ | 25MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2012-06-28 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | N202611-002 | MYRBETRIQ | 50MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2012-06-28 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N202611-001 | MYRBETRIQ | 25MG | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2012-06-28 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N202611-002 | MYRBETRIQ | 50MG | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2012-06-28 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N202611-001 | MYRBETRIQ | 25MG | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2012-06-28 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N202611-002 | MYRBETRIQ | 50MG | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2012-06-28 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N202611-001 | MYRBETRIQ | 25MG | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2012-06-28 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | N202611-002 | MYRBETRIQ | 50MG | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2012-06-28 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N202611-001 | MYRBETRIQ | 25MG | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2012-06-28 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N202611-002 | MYRBETRIQ | 50MG | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2012-06-28 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | N202611-001 | MYRBETRIQ | 25MG | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2012-06-28 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | N202611-002 | MYRBETRIQ | 50MG | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2012-06-28 | bb7c543d1eb4… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | N202611-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N202611-002 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N202611-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N202611-002 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N202611-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N202611-002 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N202611-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N202611-002 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N202611-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N202611-002 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N202611-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N202611-002 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N202611-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N202611-002 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N202611-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N202611-002 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N202611-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N202611-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N202611-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N202611-002 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N202611-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N202611-002 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N202611-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N202611-002 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N202611-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N202611-002 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N202611-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N202611-002 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N202611-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | N202611-002 | AB | 1 | 8072bd15b7f6… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N202611-001 | AB | 1 | 6a51e52b5d6a… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N202611-002 | AB | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | N202611-001 | AB | 1 | 1c564ffb4f44… |
| 2024-02-18 07:12 UTC | 2024-02 | N202611-002 | AB | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | N202611-001 | AB | 1 | ea1830bbd6c7… |
| 2023-12-20 04:57 UTC | 2023-12 | N202611-002 | AB | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N202611-001 | AB | 1 | a72a2bbeb626… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N202611-002 | AB | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N202611-001 | AB | 1 | 9b2671bbb829… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N202611-002 | AB | 1 | 9b2671bbb829… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | N202611-001 | 8772315 | 2028-10-30 | U-2300 | 2018-05-17 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N202611-001 | 8772315*PED | 2029-04-30 | Pediatric extension | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N202611-001 | 10842780 | 2029-09-28 | U-3670 | Drug product | 2020-12-11 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N202611-001 | 10842780 | 2029-09-28 | U-2996 | Drug product | 2020-12-11 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N202611-001 | 11707451 | 2029-09-28 | U-2996 | 2023-08-21 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N202611-001 | 11707451 | 2029-09-28 | U-3670 | 2023-08-21 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N202611-001 | 12059409 | 2029-09-28 | Drug product | 2024-08-28 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N202611-001 | 12097189 | 2029-09-28 | U-2996 | 2024-10-02 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N202611-001 | 12097189 | 2029-09-28 | U-3670 | 2024-10-02 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N202611-001 | 10842780*PED | 2030-03-28 | Pediatric extension | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N202611-001 | 11707451*PED | 2030-03-28 | Pediatric extension | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N202611-001 | 12059409*PED | 2030-03-28 | Pediatric extension | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N202611-001 | 12097189*PED | 2030-03-28 | Pediatric extension | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N202611-002 | 8772315 | 2028-10-30 | U-2300 | 2018-05-17 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N202611-002 | 8772315*PED | 2029-04-30 | Pediatric extension | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N202611-002 | 10842780 | 2029-09-28 | U-3670 | Drug product | 2020-12-11 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N202611-002 | 10842780 | 2029-09-28 | U-2996 | Drug product | 2020-12-11 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N202611-002 | 11707451 | 2029-09-28 | U-2996 | 2023-08-21 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N202611-002 | 11707451 | 2029-09-28 | U-3670 | 2023-08-21 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N202611-002 | 12059409 | 2029-09-28 | Drug product | 2024-08-28 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N202611-002 | 12097189 | 2029-09-28 | U-2996 | 2024-10-02 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N202611-002 | 12097189 | 2029-09-28 | U-3670 | 2024-10-02 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N202611-002 | 10842780*PED | 2030-03-28 | Pediatric extension | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N202611-002 | 11707451*PED | 2030-03-28 | Pediatric extension | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N202611-002 | 12059409*PED | 2030-03-28 | Pediatric extension | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N202611-002 | 12097189*PED | 2030-03-28 | Pediatric extension | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N202611-001 | 8772315 | 2028-10-30 | U-2300 | 2018-05-17 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202611-001 | 8772315*PED | 2029-04-30 | Pediatric extension | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N202611-001 | 10842780 | 2029-09-28 | U-3670 | Drug product | 2020-12-11 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N202611-001 | 10842780 | 2029-09-28 | U-2996 | Drug product | 2020-12-11 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N202611-001 | 11707451 | 2029-09-28 | U-2996 | 2023-08-21 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202611-001 | 11707451 | 2029-09-28 | U-3670 | 2023-08-21 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202611-001 | 12059409 | 2029-09-28 | Drug product | 2024-08-28 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202611-001 | 12097189 | 2029-09-28 | U-2996 | 2024-10-02 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202611-001 | 12097189 | 2029-09-28 | U-3670 | 2024-10-02 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202611-001 | 10842780*PED | 2030-03-28 | Pediatric extension | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N202611-001 | 11707451*PED | 2030-03-28 | Pediatric extension | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N202611-001 | 12059409*PED | 2030-03-28 | Pediatric extension | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N202611-001 | 12097189*PED | 2030-03-28 | Pediatric extension | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N202611-002 | 8772315 | 2028-10-30 | U-2300 | 2018-05-17 | 011fe1cb6892… |
Observed Orange Book exclusivity history#
| Captured | Edition | Application-product | Exclusivity code | Expiration | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N202611-001 | I-855 | 2024-03-25 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N202611-001 | PED | 2024-09-25 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N202611-002 | I-855 | 2024-03-25 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N202611-002 | PED | 2024-09-25 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N202611-001 | I-855 | 2024-03-25 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N202611-001 | PED | 2024-09-25 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N202611-002 | I-855 | 2024-03-25 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N202611-002 | PED | 2024-09-25 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N202611-001 | I-855 | 2024-03-25 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N202611-001 | PED | 2024-09-25 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N202611-002 | I-855 | 2024-03-25 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N202611-002 | PED | 2024-09-25 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N202611-001 | I-855 | 2024-03-25 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N202611-001 | PED | 2024-09-25 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N202611-002 | I-855 | 2024-03-25 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N202611-002 | PED | 2024-09-25 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N202611-001 | I-855 | 2024-03-25 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N202611-001 | PED | 2024-09-25 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N202611-002 | I-855 | 2024-03-25 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N202611-002 | PED | 2024-09-25 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N202611-001 | I-855 | 2024-03-25 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N202611-001 | PED | 2024-09-25 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N202611-002 | I-855 | 2024-03-25 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N202611-002 | PED | 2024-09-25 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N202611-001 | I-855 | 2024-03-25 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N202611-001 | PED | 2024-09-25 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N202611-002 | I-855 | 2024-03-25 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N202611-002 | PED | 2024-09-25 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N202611-001 | I-855 | 2024-03-25 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N202611-001 | PED | 2024-09-25 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N202611-002 | I-855 | 2024-03-25 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N202611-002 | PED | 2024-09-25 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N202611-001 | I-855 | 2024-03-25 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | N202611-001 | PED | 2024-09-25 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | N202611-002 | I-855 | 2024-03-25 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | N202611-002 | PED | 2024-09-25 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N202611-001 | I-855 | 2024-03-25 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N202611-001 | PED | 2024-09-25 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N202611-002 | I-855 | 2024-03-25 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N202611-002 | PED | 2024-09-25 | 5c6f7cd8ea54… |
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 |
|---|---|---|---|---|---|---|
| Myrbetriq | MIRABEGRON | Astellas Pharma US, Inc. | ba9e9e15-e666-4c56-9271-2e24739cfa2d | 2024-08-01 | Warnings, Adverse reactions | 202611 NDA202611 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 70518-3158-0 | 70518315800 | 30 POUCH in 1 BOX (70518-3158-0) > 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 POUCH (70518-3158-1) | 30 pouch | 2021-07-15 | 0000-00-00 | No | No | Current |
| 70518-3158-2 | 70518315802 | 30 POUCH in 1 BOX (70518-3158-2) > 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 POUCH (70518-3158-3) | 30 pouch | 2022-01-31 | 0000-00-00 | No | No | Current |