Toviaz
- Product NDC
- 69189-0244
- 11-digit product format
- 691890244
- Labeler code
- 69189
- Product ID
- 69189-0244_bc03a590-7608-4e1e-a407-2c55bed5814c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- fesoterodine fumarate
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Avera McKennan Hospital
- Application
- NDA022030
- Marketing category
- NDA
- Marketing start
- 2015-06-10
- Marketing end
- 0000-00-00
- Substance
- FESOTERODINE FUMARATE
- Active strength
- 8 mg/1
- NDC exclude flag
- E
- Listing certified through
- 2018-12-31
- 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 | 69189-0244 | I | Inactivated by FDA | 2026-09-09 | ||
| excluded package | package | 69189-0244 | 69189-0244-1 | I | Inactivated by FDA | 2026-09-09 |
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 | Code | Status | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | I | Inactivated by FDA | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 69189-0244-1 | I | Inactivated by FDA | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | I | Inactivated by FDA | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 69189-0244-1 | I | Inactivated by FDA | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 69189-0244-1 | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 69189-0244-1 | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 69189-0244-1 | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 69189-0244-1 | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | I | Inactivated by FDA | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 69189-0244-1 | I | Inactivated by FDA | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | I | Inactivated by FDA | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 69189-0244-1 | I | Inactivated by FDA | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | I | Inactivated by FDA | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 69189-0244-1 | I | Inactivated by FDA | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded product | product | I | Inactivated by FDA | ad56d346431e… | cc804d4bbf1e… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 69189-0244-1 | I | Inactivated by FDA | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded product | product | I | Inactivated by FDA | 367a005e9d99… | 383a685ebd0f… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 69189-0244-1 | I | Inactivated by FDA | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded product | product | I | Inactivated by FDA | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 69189-0244-1 | I | Inactivated by FDA | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded product | product | I | Inactivated by FDA | 8af77b9d5b6f… | d9bbb34c5368… | |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded package | package | 69189-0244-1 | I | Inactivated by FDA | 8af77b9d5b6f… | d9bbb34c5368… |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded product | product | I | Inactivated by FDA | 834df4deac94… | adcc014656a3… | |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded package | package | 69189-0244-1 | I | Inactivated by FDA | 834df4deac94… | adcc014656a3… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded product | product | I | Inactivated by FDA | 1332a3947898… | d4bfe170f9cd… | |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded package | package | 69189-0244-1 | I | Inactivated by FDA | 1332a3947898… | d4bfe170f9cd… |
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded product | product | I | Inactivated by FDA | fb8cb913e6d1… | eb8c232b6be0… | |
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded package | package | 69189-0244-1 | I | Inactivated by FDA | fb8cb913e6d1… | eb8c232b6be0… |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded product | product | I | Inactivated by FDA | 86f5da6cb304… | a595104c45d7… | |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded package | package | 69189-0244-1 | I | Inactivated by FDA | 86f5da6cb304… | a595104c45d7… |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded product | product | I | Inactivated by FDA | bd6a592717d7… | 303034d00443… | |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded package | package | 69189-0244-1 | I | Inactivated by FDA | bd6a592717d7… | 303034d00443… |
| 2021-12-27 23:28 UTC · source 2021-12-27 | excluded product | product | I | Inactivated by FDA | 8dfbde2a14a4… | c9ff85d89658… | |
| 2021-12-27 23:28 UTC · source 2021-12-27 | excluded package | package | 69189-0244-1 | I | Inactivated by FDA | 8dfbde2a14a4… | c9ff85d89658… |
| 2020-12-18 03:04 UTC · source 2020-12-17 | excluded product | product | I | Inactivated by FDA | e2bbac7714bc… | 27bdfed8d636… | |
| 2020-12-18 03:04 UTC · source 2020-12-17 | excluded package | package | 69189-0244-1 | I | Inactivated by FDA | e2bbac7714bc… | 27bdfed8d636… |
| 2020-06-10 20:45 UTC · source 2020-06-10 | excluded product | product | I | Inactivated by FDA | 9bebd1f3094a… | 5416666fcb17… | |
| 2020-06-10 20:45 UTC · source 2020-06-10 | excluded package | package | 69189-0244-1 | I | Inactivated by FDA | 9bebd1f3094a… | 5416666fcb17… |
| 2019-12-08 06:16 UTC · source 2019-12-05 | excluded product | product | E | Excluded after deficient or non-compliant submission was not corrected | 110d247fa046… | a55b01930146… | |
| 2019-12-08 06:16 UTC · source 2019-12-05 | excluded package | package | 69189-0244-1 | E | Excluded after deficient or non-compliant submission was not corrected | 110d247fa046… | a55b01930146… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N022030-001 | TOVIAZ | FESOTERODINE FUMARATE | 4MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2008-10-31 |
| N022030-002 | TOVIAZ | FESOTERODINE FUMARATE | 8MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2008-10-31 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N022030-001 | AB |
| N022030-002 | AB |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N022030-001 | 7807715 | 2027-06-07 | U-913 | Drug product | |
| N022030-001 | 8088398 | 2027-06-07 | U-913 | Drug product | |
| N022030-001 | 8501723 | 2027-06-07 | Drug product | 2013-08-20 | |
| N022030-001 | 7807715*PED | 2027-12-07 | Pediatric extension | ||
| N022030-001 | 8088398*PED | 2027-12-07 | Pediatric extension | ||
| N022030-001 | 8501723*PED | 2027-12-07 | Pediatric extension | ||
| N022030-002 | 7807715 | 2027-06-07 | U-913 | Drug product | |
| N022030-002 | 8088398 | 2027-06-07 | U-913 | Drug product | |
| N022030-002 | 8501723 | 2027-06-07 | Drug product | 2013-08-20 | |
| N022030-002 | 7807715*PED | 2027-12-07 | Pediatric extension | ||
| N022030-002 | 8088398*PED | 2027-12-07 | Pediatric extension | ||
| N022030-002 | 8501723*PED | 2027-12-07 | 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 | N022030-001 | TOVIAZ | 4MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2008-10-31 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N022030-002 | TOVIAZ | 8MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2008-10-31 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N022030-001 | TOVIAZ | 4MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2008-10-31 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N022030-002 | TOVIAZ | 8MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2008-10-31 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022030-001 | TOVIAZ | 4MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2008-10-31 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022030-002 | TOVIAZ | 8MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2008-10-31 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N022030-001 | TOVIAZ | 4MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2008-10-31 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N022030-002 | TOVIAZ | 8MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2008-10-31 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022030-001 | TOVIAZ | 4MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2008-10-31 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022030-002 | TOVIAZ | 8MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2008-10-31 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022030-001 | TOVIAZ | 4MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2008-10-31 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022030-002 | TOVIAZ | 8MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2008-10-31 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022030-001 | TOVIAZ | 4MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2008-10-31 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022030-002 | TOVIAZ | 8MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2008-10-31 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022030-001 | TOVIAZ | 4MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2008-10-31 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022030-002 | TOVIAZ | 8MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2008-10-31 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022030-001 | TOVIAZ | 4MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2008-10-31 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022030-002 | TOVIAZ | 8MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2008-10-31 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022030-001 | TOVIAZ | 4MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2008-10-31 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022030-002 | TOVIAZ | 8MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2008-10-31 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N022030-001 | TOVIAZ | 4MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2008-10-31 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N022030-002 | TOVIAZ | 8MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2008-10-31 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N022030-001 | TOVIAZ | 4MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2008-10-31 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N022030-002 | TOVIAZ | 8MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2008-10-31 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N022030-001 | TOVIAZ | 4MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2008-10-31 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N022030-002 | TOVIAZ | 8MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2008-10-31 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N022030-001 | TOVIAZ | 4MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2008-10-31 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N022030-002 | TOVIAZ | 8MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2008-10-31 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N022030-001 | TOVIAZ | 4MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2008-10-31 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | N022030-002 | TOVIAZ | 8MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2008-10-31 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022030-001 | TOVIAZ | 4MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2008-10-31 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022030-002 | TOVIAZ | 8MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2008-10-31 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N022030-001 | TOVIAZ | 4MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2008-10-31 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N022030-002 | TOVIAZ | 8MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2008-10-31 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N022030-001 | TOVIAZ | 4MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2008-10-31 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N022030-002 | TOVIAZ | 8MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2008-10-31 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | N022030-001 | TOVIAZ | 4MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2008-10-31 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N022030-002 | TOVIAZ | 8MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2008-10-31 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | N022030-001 | TOVIAZ | 4MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2008-10-31 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | N022030-002 | TOVIAZ | 8MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2008-10-31 | 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 | N022030-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N022030-002 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N022030-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N022030-002 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022030-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022030-002 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N022030-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N022030-002 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022030-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022030-002 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022030-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022030-002 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022030-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022030-002 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022030-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022030-002 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022030-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022030-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022030-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022030-002 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N022030-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N022030-002 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N022030-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N022030-002 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N022030-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N022030-002 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N022030-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N022030-002 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N022030-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | N022030-002 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022030-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022030-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N022030-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N022030-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N022030-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N022030-002 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | N022030-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N022030-002 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | N022030-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | N022030-002 | AB | 1 | bb7c543d1eb4… |
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 | N022030-001 | 7807715 | 2027-06-07 | U-913 | Drug product | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N022030-001 | 8088398 | 2027-06-07 | U-913 | Drug product | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N022030-001 | 8501723 | 2027-06-07 | Drug product | 2013-08-20 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N022030-001 | 7807715*PED | 2027-12-07 | Pediatric extension | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N022030-001 | 8088398*PED | 2027-12-07 | Pediatric extension | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N022030-001 | 8501723*PED | 2027-12-07 | Pediatric extension | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N022030-002 | 7807715 | 2027-06-07 | U-913 | Drug product | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N022030-002 | 8088398 | 2027-06-07 | U-913 | Drug product | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N022030-002 | 8501723 | 2027-06-07 | Drug product | 2013-08-20 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N022030-002 | 7807715*PED | 2027-12-07 | Pediatric extension | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N022030-002 | 8088398*PED | 2027-12-07 | Pediatric extension | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N022030-002 | 8501723*PED | 2027-12-07 | Pediatric extension | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N022030-001 | 7807715 | 2027-06-07 | U-913 | Drug product | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022030-001 | 8088398 | 2027-06-07 | U-913 | Drug product | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022030-001 | 8501723 | 2027-06-07 | Drug product | 2013-08-20 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022030-001 | 7807715*PED | 2027-12-07 | Pediatric extension | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N022030-001 | 8088398*PED | 2027-12-07 | Pediatric extension | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N022030-001 | 8501723*PED | 2027-12-07 | Pediatric extension | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N022030-002 | 7807715 | 2027-06-07 | U-913 | Drug product | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022030-002 | 8088398 | 2027-06-07 | U-913 | Drug product | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022030-002 | 8501723 | 2027-06-07 | Drug product | 2013-08-20 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022030-002 | 7807715*PED | 2027-12-07 | Pediatric extension | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N022030-002 | 8088398*PED | 2027-12-07 | Pediatric extension | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N022030-002 | 8501723*PED | 2027-12-07 | Pediatric extension | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022030-001 | 7807715 | 2027-06-07 | U-913 | Drug product | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022030-001 | 8088398 | 2027-06-07 | U-913 | Drug product | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022030-001 | 8501723 | 2027-06-07 | Drug product | 2013-08-20 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022030-001 | 7807715*PED | 2027-12-07 | Pediatric extension | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022030-001 | 8088398*PED | 2027-12-07 | Pediatric extension | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022030-001 | 8501723*PED | 2027-12-07 | Pediatric extension | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022030-002 | 7807715 | 2027-06-07 | U-913 | Drug product | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022030-002 | 8088398 | 2027-06-07 | U-913 | Drug product | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022030-002 | 8501723 | 2027-06-07 | Drug product | 2013-08-20 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022030-002 | 7807715*PED | 2027-12-07 | Pediatric extension | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022030-002 | 8088398*PED | 2027-12-07 | Pediatric extension | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022030-002 | 8501723*PED | 2027-12-07 | Pediatric extension | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N022030-001 | 7807715 | 2027-06-07 | U-913 | Drug product | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022030-001 | 8088398 | 2027-06-07 | U-913 | Drug product | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022030-001 | 8501723 | 2027-06-07 | Drug product | 2013-08-20 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022030-001 | 7807715*PED | 2027-12-07 | Pediatric extension | 6a471c1ec25d… |
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 | N022030-001 | I-861 | 2024-06-17 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022030-001 | PED | 2024-12-17 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022030-002 | I-861 | 2024-06-17 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022030-002 | PED | 2024-12-17 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022030-001 | I-861 | 2024-06-17 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022030-001 | PED | 2024-12-17 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022030-002 | I-861 | 2024-06-17 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022030-002 | PED | 2024-12-17 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022030-001 | I-861 | 2024-06-17 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022030-001 | PED | 2024-12-17 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022030-002 | I-861 | 2024-06-17 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022030-002 | PED | 2024-12-17 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022030-001 | I-861 | 2024-06-17 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022030-001 | PED | 2024-12-17 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022030-002 | I-861 | 2024-06-17 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022030-002 | PED | 2024-12-17 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N022030-001 | I-861 | 2024-06-17 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N022030-001 | PED | 2024-12-17 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N022030-002 | I-861 | 2024-06-17 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N022030-002 | PED | 2024-12-17 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N022030-001 | I-861 | 2024-06-17 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N022030-001 | PED | 2024-12-17 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N022030-002 | I-861 | 2024-06-17 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N022030-002 | PED | 2024-12-17 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N022030-001 | I-861 | 2024-06-17 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N022030-001 | PED | 2024-12-17 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N022030-002 | I-861 | 2024-06-17 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N022030-002 | PED | 2024-12-17 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N022030-001 | I-861 | 2024-06-17 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N022030-001 | PED | 2024-12-17 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N022030-002 | I-861 | 2024-06-17 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N022030-002 | PED | 2024-12-17 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N022030-001 | I-861 | 2024-06-17 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | N022030-001 | PED | 2024-12-17 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | N022030-002 | I-861 | 2024-06-17 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | N022030-002 | PED | 2024-12-17 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022030-001 | I-861 | 2024-06-17 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022030-001 | PED | 2024-12-17 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022030-002 | I-861 | 2024-06-17 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022030-002 | PED | 2024-12-17 | 5c6f7cd8ea54… |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 929b9598-46e7-5b66-7a86-5544524fb173 | Product name | 6 | 20240208 |
| 351abe41-466c-4dd8-840a-0fdb68318bd5 | Product name | 1 | 20230316 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 69189-0244-1 | 2020-01-31 | C162847 | 48780-1 | 9d75b9cf-d2f2-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use TOVIAZ safely and effectively. See full prescribing information for TOVIAZ. Toviaz ® (fesoterodine fumarate) For oral administration Initial U.S. Approval: 2008 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 69189-0244-1 | Toviaz | 1 in 1 DOSE PACK | TABLET, FILM COATED, EXTENDED RE | 1 | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 69189-0244 | TOVIAZ (FESOTERODINE FUMARATE) TABLET, FILM COATED, EXTENDED RELEASE [AVERA MCKENNAN HOSPITAL] | 1 | Legacy NDC, 1 package rows | 20170414_e44e0f9d-6ff7-4a3d-995a-a2768bf9ac26.zip |
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 |
|---|---|---|---|---|---|---|
| Toviaz | FESOTERODINE FUMARATE | Pfizer Laboratories Div Pfizer Inc | 5be745f0-8ae7-4c3c-9962-37d6263326f1 | 2026-04-07 | Warnings, Adverse reactions | 022030 NDA022030 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 810077 | fesoterodine fumarate 8 MG 24HR Extended Release Oral Tablet | PSN | e44e0f9d-6ff7-4a3d-995a-a2768bf9ac26 | 1 |
| 810079 | Toviaz 8 MG 24HR Extended Release Oral Tablet | PSN | e44e0f9d-6ff7-4a3d-995a-a2768bf9ac26 | 1 |
| 810079 | 24 HR fesoterodine fumarate 8 MG Extended Release Oral Tablet [Toviaz] | SBD | e44e0f9d-6ff7-4a3d-995a-a2768bf9ac26 | 1 |
| 810077 | 24 HR fesoterodine fumarate 8 MG Extended Release Oral Tablet | SCD | e44e0f9d-6ff7-4a3d-995a-a2768bf9ac26 | 1 |
| 810079 | 24 HR Toviaz 8 MG Extended Release Oral Tablet | SY | e44e0f9d-6ff7-4a3d-995a-a2768bf9ac26 | 1 |
| 810077 | fesoterodine fumarate 8 MG 24 HR Extended Release Oral Tablet | SY | e44e0f9d-6ff7-4a3d-995a-a2768bf9ac26 | 1 |
| 810079 | Toviaz 8 MG 24 HR Extended Release Oral Tablet | SY | e44e0f9d-6ff7-4a3d-995a-a2768bf9ac26 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 69189-0244-1 | 69189024401 | 1 in 1 DOSE PACK | Historical |