Tolterodine Tartrate Extended Release
- Product NDC
- 59762-0047
- 11-digit product format
- 597620047
- Labeler code
- 59762
- Product ID
- 59762-0047_41ea8bd1-9374-41a1-8a14-f77ec72f0273
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- tolterodine tartrate
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Mylan Pharmaceuticals Inc.
- Application
- NDA021228
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2016-01-22
- Marketing end
- 2026-07-31
- Substance
- TOLTERODINE TARTRATE
- Active strength
- 2 mg/1
- Pharmacologic classes
- Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]
- NDC exclude flag
- No
- Current FDA listing
- Yes
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 59762-0047 | D | Discontinued by firm | 2026-08-17 | ||
| excluded package | package | 59762-0047 | 59762-0047-1 | D | Discontinued by firm | 2026-08-17 | |
| excluded package | package | 59762-0047 | 59762-0047-2 | D | Discontinued by firm | 2026-08-17 |
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 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 59762-0047-1 | Tolterodine Tartrate Extended Release | 30 in 1 BOTTLE | CAPSULE, EXTENDED RELEASE | 30 | 9 | |
| 59762-0047-2 | Tolterodine Tartrate Extended Release | 90 in 1 BOTTLE | CAPSULE, EXTENDED RELEASE | 90 | 9 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 59762-0047-1 | EA - Each | 59762-0047 | 20630856-a568-47e8-aa10-dd58649a1326 | 1 | 2016-02-04 |
| 59762-0047-2 | EA - Each | 59762-0047 | 15460a87-a80d-4ee4-a01d-5e2c5e08896b | 1 | 2016-02-04 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 59762-0047 | TOLTERODINE TARTRATE EXTENDED RELEASE (TOLTERODINE TARTRATE) CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.] | 8 | Current NDC, Legacy NDC, 2 package rows | 20250504_0565f75a-3f4f-436e-930e-c31c6fa2b1e7.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 855182 | tolterodine tartrate 2 MG 24HR Extended Release Oral Capsule | PSN | 0565f75a-3f4f-436e-930e-c31c6fa2b1e7 | 9 |
| 855189 | tolterodine tartrate 4 MG 24HR Extended Release Oral Capsule | PSN | 0565f75a-3f4f-436e-930e-c31c6fa2b1e7 | 9 |
| 855182 | 24 HR tolterodine tartrate 2 MG Extended Release Oral Capsule | SCD | 0565f75a-3f4f-436e-930e-c31c6fa2b1e7 | 9 |
| 855189 | 24 HR tolterodine tartrate 4 MG Extended Release Oral Capsule | SCD | 0565f75a-3f4f-436e-930e-c31c6fa2b1e7 | 9 |
| 855182 | tolterodine tartrate 2 MG 24 HR Extended Release Oral Capsule | SY | 0565f75a-3f4f-436e-930e-c31c6fa2b1e7 | 9 |
| 855189 | tolterodine tartrate 4 MG 24 HR Extended Release Oral Capsule | SY | 0565f75a-3f4f-436e-930e-c31c6fa2b1e7 | 9 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 59762-0047-1 | 59762004701 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (59762-0047-1) | 2016-01-22 | 2026-07-31 | No | No | Current |
| 59762-0047-2 | 59762004702 | 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (59762-0047-2) | 2016-01-22 | 2026-07-31 | No | No | Current |
| 59762-0047-3 | 59762004703 | 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (59762-0047-3) | 2016-01-22 | 0000-00-00 | No | No | Current |