Detrol LA
- Product NDC
- 69189-5190
- 11-digit product format
- 691895190
- Labeler code
- 69189
- Product ID
- 69189-5190_7a741f41-ad7c-425b-b0a7-af78e490b4d5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- tolterodine tartrate
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Avera McKennan Hospital
- Application
- NDA021228
- Marketing category
- NDA
- Marketing start
- 2016-03-16
- Marketing end
- 0000-00-00
- Substance
- TOLTERODINE TARTRATE
- Active strength
- 2 mg/1
- Pharmacologic classes
- Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA]
- 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 | 69189-5190 | I | Inactivated by FDA | 2026-08-17 | ||
| excluded package | package | 69189-5190 | 69189-5190-1 | I | Inactivated by FDA | 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 | 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 | 69189-5190-1 | 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 | 69189-5190-1 | 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 | 69189-5190-1 | 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 | 69189-5190-1 | 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 | 69189-5190-1 | 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 | 69189-5190-1 | 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 | 69189-5190-1 | 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 | 69189-5190-1 | 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 | 69189-5190-1 | 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 | 69189-5190-1 | 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 | 69189-5190-1 | 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 | 69189-5190-1 | 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 | 69189-5190-1 | 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 | 69189-5190-1 | 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 | 69189-5190-1 | 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 | 69189-5190-1 | 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 | 69189-5190-1 | 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 | 69189-5190-1 | 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 | 69189-5190-1 | 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 | 69189-5190-1 | 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 | 69189-5190-1 | 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 | 69189-5190-1 | 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 |
|---|---|---|---|---|---|---|---|
| N021228-001 | DETROL LA | TOLTERODINE TARTRATE | 2MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2000-12-22 |
| N021228-002 | DETROL LA | TOLTERODINE TARTRATE | 4MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2000-12-22 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N021228-001 | AB |
| N021228-002 | AB |
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 | N021228-001 | DETROL LA | 2MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2000-12-22 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N021228-002 | DETROL LA | 4MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2000-12-22 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N021228-001 | DETROL LA | 2MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2000-12-22 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021228-002 | DETROL LA | 4MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2000-12-22 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021228-001 | DETROL LA | 2MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2000-12-22 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021228-002 | DETROL LA | 4MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2000-12-22 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N021228-001 | DETROL LA | 2MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2000-12-22 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021228-002 | DETROL LA | 4MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2000-12-22 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021228-001 | DETROL LA | 2MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2000-12-22 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021228-002 | DETROL LA | 4MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2000-12-22 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021228-001 | DETROL LA | 2MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2000-12-22 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021228-002 | DETROL LA | 4MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2000-12-22 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021228-001 | DETROL LA | 2MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2000-12-22 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021228-002 | DETROL LA | 4MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2000-12-22 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021228-001 | DETROL LA | 2MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2000-12-22 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021228-002 | DETROL LA | 4MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2000-12-22 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021228-001 | DETROL LA | 2MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2000-12-22 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021228-002 | DETROL LA | 4MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2000-12-22 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021228-001 | DETROL LA | 2MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2000-12-22 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021228-002 | DETROL LA | 4MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2000-12-22 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N021228-001 | DETROL LA | 2MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2000-12-22 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N021228-002 | DETROL LA | 4MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2000-12-22 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021228-001 | DETROL LA | 2MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2000-12-22 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021228-002 | DETROL LA | 4MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2000-12-22 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021228-001 | DETROL LA | 2MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2000-12-22 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021228-002 | DETROL LA | 4MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2000-12-22 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021228-001 | DETROL LA | 2MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2000-12-22 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021228-002 | DETROL LA | 4MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2000-12-22 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N021228-001 | DETROL LA | 2MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2000-12-22 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | N021228-002 | DETROL LA | 4MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2000-12-22 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021228-001 | DETROL LA | 2MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2000-12-22 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021228-002 | DETROL LA | 4MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2000-12-22 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N021228-001 | DETROL LA | 2MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2000-12-22 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N021228-002 | DETROL LA | 4MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2000-12-22 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N021228-001 | DETROL LA | 2MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2000-12-22 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N021228-002 | DETROL LA | 4MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2000-12-22 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | N021228-001 | DETROL LA | 2MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2000-12-22 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N021228-002 | DETROL LA | 4MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2000-12-22 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | N021228-001 | DETROL LA | 2MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2000-12-22 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | N021228-002 | DETROL LA | 4MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2000-12-22 | 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 | N021228-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N021228-002 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N021228-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021228-002 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021228-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021228-002 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N021228-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021228-002 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021228-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021228-002 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021228-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021228-002 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021228-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021228-002 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021228-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021228-002 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021228-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021228-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021228-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021228-002 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N021228-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N021228-002 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021228-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021228-002 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021228-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021228-002 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021228-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021228-002 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N021228-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | N021228-002 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021228-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021228-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N021228-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N021228-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N021228-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N021228-002 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | N021228-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N021228-002 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | N021228-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | N021228-002 | AB | 1 | bb7c543d1eb4… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | N021228-001 | 6770295 | 2019-08-26 | U-544 | Drug product | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N021228-001 | 6630162 | 2019-11-11 | U-544 | Drug product | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N021228-001 | 6911217 | 2019-11-11 | U-544 | Drug product | 2013-04-30 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N021228-001 | 6770295*PED | 2020-02-26 | Pediatric extension | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021228-001 | 6630162*PED | 2020-05-11 | Pediatric extension | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021228-001 | 6911217*PED | 2020-05-11 | Pediatric extension | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021228-002 | 6770295 | 2019-08-26 | U-544 | Drug product | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N021228-002 | 6630162 | 2019-11-11 | U-544 | Drug product | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N021228-002 | 6911217 | 2019-11-11 | U-544 | Drug product | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N021228-002 | 6770295*PED | 2020-02-26 | Pediatric extension | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021228-002 | 6630162*PED | 2020-05-11 | Pediatric extension | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021228-002 | 6911217*PED | 2020-05-11 | Pediatric extension | 74a2ff9319b5… | ||
| 2020-12-22 03:56 UTC | 2020-12 | N021228-001 | 6770295*PED | 2020-02-26 | Pediatric extension | 8869cabd3fbd… | ||
| 2020-12-22 03:56 UTC | 2020-12 | N021228-001 | 6630162*PED | 2020-05-11 | Pediatric extension | 8869cabd3fbd… | ||
| 2020-12-22 03:56 UTC | 2020-12 | N021228-001 | 6911217*PED | 2020-05-11 | Pediatric extension | 8869cabd3fbd… | ||
| 2020-12-22 03:56 UTC | 2020-12 | N021228-002 | 6770295*PED | 2020-02-26 | Pediatric extension | 8869cabd3fbd… | ||
| 2020-12-22 03:56 UTC | 2020-12 | N021228-002 | 6630162*PED | 2020-05-11 | Pediatric extension | 8869cabd3fbd… | ||
| 2020-12-22 03:56 UTC | 2020-12 | N021228-002 | 6911217*PED | 2020-05-11 | Pediatric extension | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | N021228-001 | 6770295*PED | 2020-02-26 | Pediatric extension | c0c555d07b60… | ||
| 2020-11-12 02:37 UTC | 2020-11 | N021228-001 | 6630162*PED | 2020-05-11 | Pediatric extension | c0c555d07b60… | ||
| 2020-11-12 02:37 UTC | 2020-11 | N021228-001 | 6911217*PED | 2020-05-11 | Pediatric extension | c0c555d07b60… | ||
| 2020-11-12 02:37 UTC | 2020-11 | N021228-002 | 6770295*PED | 2020-02-26 | Pediatric extension | c0c555d07b60… | ||
| 2020-11-12 02:37 UTC | 2020-11 | N021228-002 | 6630162*PED | 2020-05-11 | Pediatric extension | c0c555d07b60… | ||
| 2020-11-12 02:37 UTC | 2020-11 | N021228-002 | 6911217*PED | 2020-05-11 | Pediatric extension | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N021228-001 | 6770295 | 2019-08-26 | U-544 | Drug product | 3f01610625f2… | |
| 2019-12-14 00:12 UTC | 2019-12 | N021228-001 | 6630162 | 2019-11-11 | U-544 | Drug product | 3f01610625f2… | |
| 2019-12-14 00:12 UTC | 2019-12 | N021228-001 | 6911217 | 2019-11-11 | U-544 | Drug product | 2013-04-30 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | N021228-001 | 6770295*PED | 2020-02-26 | Pediatric extension | 3f01610625f2… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N021228-001 | 6630162*PED | 2020-05-11 | Pediatric extension | 3f01610625f2… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N021228-001 | 6911217*PED | 2020-05-11 | Pediatric extension | 3f01610625f2… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N021228-002 | 6770295 | 2019-08-26 | U-544 | Drug product | 3f01610625f2… | |
| 2019-12-14 00:12 UTC | 2019-12 | N021228-002 | 6630162 | 2019-11-11 | U-544 | Drug product | 3f01610625f2… | |
| 2019-12-14 00:12 UTC | 2019-12 | N021228-002 | 6911217 | 2019-11-11 | U-544 | Drug product | 3f01610625f2… | |
| 2019-12-14 00:12 UTC | 2019-12 | N021228-002 | 6770295*PED | 2020-02-26 | Pediatric extension | 3f01610625f2… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N021228-002 | 6630162*PED | 2020-05-11 | Pediatric extension | 3f01610625f2… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N021228-002 | 6911217*PED | 2020-05-11 | Pediatric extension | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | N021228-001 | 6770295 | 2019-08-26 | U-544 | Drug product | b00525d2431f… | |
| 2019-09-15 20:21 UTC | 2019-09 | N021228-001 | 6630162 | 2019-11-11 | U-544 | Drug product | b00525d2431f… | |
| 2019-09-15 20:21 UTC | 2019-09 | N021228-001 | 6911217 | 2019-11-11 | U-544 | Drug product | 2013-04-30 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | N021228-001 | 6770295*PED | 2020-02-26 | Pediatric extension | b00525d2431f… |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| b480943b-5b5a-aac0-c5ca-c22f479ac1a1 | Product name | 8 | 20250325 |
| a932c194-3a9e-a7d8-8961-eb5843129c16 | Product name | 6 | 20220210 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 69189-5190-1 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-56a4-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use Detrol ® LA safely and effectively. See full prescribing information for Detrol LA. Detrol ® LA (tolterodine tartrate extended release capsules) For oral administration Initial U.S. Approval: December 2000 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 69189-5190-1 | Detrol LA | 1 in 1 DOSE PACK | CAPSULE, EXTENDED RELEASE | 1 | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 69189-5190 | DETROL LA (TOLTERODINE TARTRATE) CAPSULE, EXTENDED RELEASE [AVERA MCKENNAN HOSPITAL] | 1 | Legacy NDC, 1 package rows | 20170411_88df13b1-090d-4894-a60a-878b370409c0.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 855184 | Detrol LA 2 MG 24HR Extended Release Oral Capsule | PSN | 88df13b1-090d-4894-a60a-878b370409c0 | 1 |
| 855182 | tolterodine tartrate 2 MG 24HR Extended Release Oral Capsule | PSN | 88df13b1-090d-4894-a60a-878b370409c0 | 1 |
| 855184 | 24 HR tolterodine tartrate 2 MG Extended Release Oral Capsule [Detrol] | SBD | 88df13b1-090d-4894-a60a-878b370409c0 | 1 |
| 855182 | 24 HR tolterodine tartrate 2 MG Extended Release Oral Capsule | SCD | 88df13b1-090d-4894-a60a-878b370409c0 | 1 |
| 855184 | 24 HR Detrol 2 MG Extended Release Oral Capsule | SY | 88df13b1-090d-4894-a60a-878b370409c0 | 1 |
| 855184 | Detrol LA 2 MG 24 HR Extended Release Oral Capsule | SY | 88df13b1-090d-4894-a60a-878b370409c0 | 1 |
| 855182 | tolterodine tartrate 2 MG 24 HR Extended Release Oral Capsule | SY | 88df13b1-090d-4894-a60a-878b370409c0 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 69189-5190-1 | 69189519001 | 1 in 1 DOSE PACK | Historical |