Tolterodine Tartrate
- Product NDC
- 0093-7163
- Requested package NDC
- 0093-7163-99
- 11-digit product format
- 000937163
- Labeler code
- 0093
- Product ID
- 0093-7163_acae7de6-a2b9-4475-8b25-620c0fa55235
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tolterodine Tartrate
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Teva Pharmaceuticals USA, Inc.
- Application
- ANDA079141
- Marketing category
- ANDA
- Marketing start
- 2017-03-20
- Substance
- TOLTERODINE TARTRATE
- Active strength
- 2 mg/1
- Pharmacologic classes
- Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
NDC auxiliary status#
Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| unfinished package | package | 0093-7163 | 0093-7163-99 | UNFINISHED | Active or certified unfinished drug listing | 2026-08-03 |
Observed NDC auxiliary status history#
Observed captured status history: Rows come only from successfully parsed FDA auxiliary ZIP captures. They show the state present in that artifact, not a continuous regulatory timeline. Absence before, after, or between captures is not proof of status, and a known non-data HTTP 403 capture is preserved in backfill provenance but cannot produce a status row.
| Captured / source date | Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Archive | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|---|
| 2025-12-14 21:27 UTC · source 2025-12-05 | unfinished package | package | 0093-7163 | 0093-7163-99 | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | a6255e0c9aa5… | a0211a219f2e… | |
| 2025-08-26 23:59 UTC · source 2025-08-26 | unfinished package | package | 0093-7163 | 0093-7163-99 | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | 1d862106b807… | 00c93037cd84… | |
| 2025-05-15 14:59 UTC · source 2025-05-14 | unfinished package | package | 0093-7163 | 0093-7163-99 | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | 390b4c401c3f… | 2c692c2daee3… | |
| 2025-04-01 07:37 UTC · source 2025-03-31 | unfinished package | package | 0093-7163 | 0093-7163-99 | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | e30019b0c005… | a3f0b14938b7… | |
| 2025-03-01 13:19 UTC · source 2025-02-28 | unfinished package | package | 0093-7163 | 0093-7163-99 | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | bbbc9f937eca… | 946b9c97cf81… | |
| 2025-02-27 05:24 UTC · source 2025-02-26 | unfinished package | package | 0093-7163 | 0093-7163-99 | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | f268b84574a6… | 26285f5ac5df… | |
| 2025-02-01 13:13 UTC · source 2025-01-31 | unfinished package | package | 0093-7163 | 0093-7163-99 | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | f764e8902f78… | 92046438deef… | |
| 2025-01-20 13:05 UTC · source 2025-01-17 | unfinished package | package | 0093-7163 | 0093-7163-99 | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | 68b1e3bced9e… | 98a755eb8bc6… | |
| 2024-11-29 20:42 UTC · source 2024-11-29 | unfinished package | package | 0093-7163 | 0093-7163-99 | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | 05c55d027831… | ca05dca9dc4c… | |
| 2024-11-09 02:36 UTC · source 2024-11-08 | unfinished package | package | 0093-7163 | 0093-7163-99 | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | 48b4f40e6753… | c7c7a00d2afa… | |
| 2024-10-09 02:27 UTC · source 2024-10-08 | unfinished package | package | 0093-7163 | 0093-7163-99 | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | 27f29a85d7e4… | 1372111e901f… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | unfinished package | package | 0093-7163 | 0093-7163-99 | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | 8d62ce987f31… | 9fe9ef23e30d… | |
| 2024-05-28 21:11 UTC · source 2024-05-28 | unfinished package | package | 0093-7163 | 0093-7163-99 | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | d1e113ab4d42… | 063ee3eb0a1d… | |
| 2024-05-15 03:51 UTC · source 2024-05-14 | unfinished package | package | 0093-7163 | 0093-7163-99 | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | 50b4072663b7… | eae3003ed65e… | |
| 2022-04-09 23:13 UTC · source 2022-04-08 | unfinished package | package | 0093-7163 | 0093-7163-99 | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | 906f6e251498… | bf70b80e44f0… | |
| 2021-12-27 23:28 UTC · source 2021-12-27 | unfinished package | package | 0093-7163 | 0093-7163-99 | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | 6db9cb8d1e19… | 3449e1ec5b70… | |
| 2021-02-18 23:40 UTC · source 2021-02-18 | unfinished package | package | 0093-7163 | 0093-7163-99 | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | 8fc7167e32ce… | e96bbc724034… | |
| 2020-12-18 03:04 UTC · source 2020-12-17 | unfinished package | package | 0093-7163 | 0093-7163-99 | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | 4184dd79f89f… | 545327b3e20f… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A079141-001 | TOLTERODINE TARTRATE | TOLTERODINE TARTRATE | 2MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2016-11-22 | |
| A079141-002 | TOLTERODINE TARTRATE | TOLTERODINE TARTRATE | 4MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2016-11-22 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A079141-001 | AB |
| A079141-002 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A079141-001 | TOLTERODINE TARTRATE | 2MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2016-11-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A079141-002 | TOLTERODINE TARTRATE | 4MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2016-11-22 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A079141-001 | TOLTERODINE TARTRATE | 2MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2016-11-22 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A079141-002 | TOLTERODINE TARTRATE | 4MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2016-11-22 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A079141-001 | TOLTERODINE TARTRATE | 2MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2016-11-22 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A079141-002 | TOLTERODINE TARTRATE | 4MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2016-11-22 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A079141-001 | TOLTERODINE TARTRATE | 2MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2016-11-22 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A079141-002 | TOLTERODINE TARTRATE | 4MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2016-11-22 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A079141-001 | TOLTERODINE TARTRATE | 2MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2016-11-22 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A079141-002 | TOLTERODINE TARTRATE | 4MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2016-11-22 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A079141-001 | TOLTERODINE TARTRATE | 2MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2016-11-22 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A079141-002 | TOLTERODINE TARTRATE | 4MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2016-11-22 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A079141-001 | TOLTERODINE TARTRATE | 2MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2016-11-22 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A079141-002 | TOLTERODINE TARTRATE | 4MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2016-11-22 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A079141-001 | TOLTERODINE TARTRATE | 2MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2016-11-22 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A079141-002 | TOLTERODINE TARTRATE | 4MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2016-11-22 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A079141-001 | TOLTERODINE TARTRATE | 2MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2016-11-22 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A079141-002 | TOLTERODINE TARTRATE | 4MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2016-11-22 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A079141-001 | TOLTERODINE TARTRATE | 2MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2016-11-22 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A079141-002 | TOLTERODINE TARTRATE | 4MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2016-11-22 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A079141-001 | TOLTERODINE TARTRATE | 2MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2016-11-22 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A079141-002 | TOLTERODINE TARTRATE | 4MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2016-11-22 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A079141-001 | TOLTERODINE TARTRATE | 2MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2016-11-22 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A079141-002 | TOLTERODINE TARTRATE | 4MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2016-11-22 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A079141-001 | TOLTERODINE TARTRATE | 2MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2016-11-22 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A079141-002 | TOLTERODINE TARTRATE | 4MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2016-11-22 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A079141-001 | TOLTERODINE TARTRATE | 2MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2016-11-22 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A079141-002 | TOLTERODINE TARTRATE | 4MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2016-11-22 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A079141-001 | TOLTERODINE TARTRATE | 2MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2016-11-22 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A079141-002 | TOLTERODINE TARTRATE | 4MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2016-11-22 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A079141-001 | TOLTERODINE TARTRATE | 2MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2016-11-22 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A079141-002 | TOLTERODINE TARTRATE | 4MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2016-11-22 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A079141-001 | TOLTERODINE TARTRATE | 2MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2016-11-22 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A079141-002 | TOLTERODINE TARTRATE | 4MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2016-11-22 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A079141-001 | TOLTERODINE TARTRATE | 2MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2016-11-22 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A079141-002 | TOLTERODINE TARTRATE | 4MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2016-11-22 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A079141-001 | TOLTERODINE TARTRATE | 2MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2016-11-22 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | A079141-002 | TOLTERODINE TARTRATE | 4MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2016-11-22 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A079141-001 | TOLTERODINE TARTRATE | 2MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2016-11-22 | 782e0a99824c… | |
| 2021-12-28 21:50 UTC | 2021-12 | A079141-002 | TOLTERODINE TARTRATE | 4MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2016-11-22 | 782e0a99824c… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A079141-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A079141-002 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A079141-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A079141-002 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A079141-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A079141-002 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A079141-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A079141-002 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A079141-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A079141-002 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A079141-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A079141-002 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A079141-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A079141-002 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A079141-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A079141-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A079141-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A079141-002 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A079141-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A079141-002 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A079141-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A079141-002 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A079141-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A079141-002 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A079141-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A079141-002 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A079141-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A079141-002 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A079141-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A079141-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A079141-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A079141-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A079141-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A079141-002 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A079141-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A079141-002 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A079141-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A079141-002 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A079141-001 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A079141-002 | AB | 1 | 782e0a99824c… |
openFDA label cross-check#
Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Tolterodine Tartrate | TOLTERODINE TARTRATE | A-S Medication Solutions | fd6c8b3d-a52a-4418-aa9c-0297db6c0807 | 2026-01-09 | Warnings, Adverse reactions | 079141 ANDA079141 |
| Tolterodine Tartrate | TOLTERODINE TARTRATE | Teva Pharmaceuticals USA, Inc. | 973f98b5-4e8a-42d9-ac69-d4333d21c362 | 2024-09-25 | Warnings, Adverse reactions | 079141 ANDA079141 0093-7163 |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Tolterodine Tartrate
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| TOLTERODINE TARTRATE | 2 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 5T619TQR3R | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 973f98b5-4e8a-42d9-ac69-d4333d21c362 | Available on FDA.report |
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 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0093-7163-05 | Tolterodine Tartrate | 500 in 1 BOTTLE | CAPSULE, EXTENDED RELEASE | 500 | 17 | |
| 0093-7163-56 | Tolterodine Tartrate | 30 in 1 BOTTLE | CAPSULE, EXTENDED RELEASE | 30 | 17 | |
| 0093-7163-98 | Tolterodine Tartrate | 90 in 1 BOTTLE | CAPSULE, EXTENDED RELEASE | 90 | 17 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0093-7163-05 | EA - Each | 0093-7163 | 689d105e-de84-4feb-b5a4-df16e66a4979 | 1 | 2017-04-05 |
| 0093-7163-56 | EA - Each | 0093-7163 | fca243b8-74d4-40e2-b336-a632b0c6a094 | 1 | 2017-04-05 |
| 0093-7163-98 | EA - Each | 0093-7163 | 0fc8eeeb-faa3-4bf9-817c-37c417016a84 | 1 | 2017-04-05 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 855182 | tolterodine tartrate 2 MG 24HR Extended Release Oral Capsule | PSN | 973f98b5-4e8a-42d9-ac69-d4333d21c362 | 17 |
| 855189 | tolterodine tartrate 4 MG 24HR Extended Release Oral Capsule | PSN | 973f98b5-4e8a-42d9-ac69-d4333d21c362 | 17 |
| 855182 | 24 HR tolterodine tartrate 2 MG Extended Release Oral Capsule | SCD | 973f98b5-4e8a-42d9-ac69-d4333d21c362 | 17 |
| 855189 | 24 HR tolterodine tartrate 4 MG Extended Release Oral Capsule | SCD | 973f98b5-4e8a-42d9-ac69-d4333d21c362 | 17 |
| 855182 | tolterodine tartrate 2 MG 24 HR Extended Release Oral Capsule | SY | 973f98b5-4e8a-42d9-ac69-d4333d21c362 | 17 |
| 855189 | tolterodine tartrate 4 MG 24 HR Extended Release Oral Capsule | SY | 973f98b5-4e8a-42d9-ac69-d4333d21c362 | 17 |
| 855182 | tolterodine tartrate 2 MG 24HR Extended Release Oral Capsule | PSN | cff7e184-8f72-4cec-a453-6c9fc0f01382 | 1 |
| 855182 | 24 HR tolterodine tartrate 2 MG Extended Release Oral Capsule | SCD | cff7e184-8f72-4cec-a453-6c9fc0f01382 | 1 |
| 855182 | tolterodine tartrate 2 MG 24 HR Extended Release Oral Capsule | SY | cff7e184-8f72-4cec-a453-6c9fc0f01382 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Status |
|---|---|---|---|---|
| 0093-7163-99 | 00093716399 | 30418 CAPSULE, EXTENDED RELEASE in 1 CONTAINER (0093-7163-99) | 20-OCT-20 | Current |