Tamsulosin Hydrochloride
- Product NDC
- 58118-0598
- 11-digit product format
- 581180598
- Labeler code
- 58118
- Product ID
- 58118-0598_b0269c97-f391-4da4-e053-2a95a90a0b52
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tamsulosin Hydrochloride
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Clinical Solutions Wholesale, LLC
- Application
- ANDA202433
- Marketing category
- ANDA
- Marketing start
- 2019-11-19
- Marketing end
- 0000-00-00
- Substance
- TAMSULOSIN HYDROCHLORIDE
- Active strength
- 0 mg/1
- Pharmacologic classes
- Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2021-12-31
- 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 | 58118-0598 | I | Inactivated by FDA | 2026-08-07 | ||
| excluded package | package | 58118-0598 | 58118-0598-8 | I | Inactivated by FDA | 2026-08-07 |
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Dataset | Scope | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 58118-0598-8 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 58118-0598-8 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 58118-0598-8 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 58118-0598-8 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 58118-0598-8 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 58118-0598-8 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 58118-0598-8 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 58118-0598-8 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 58118-0598-8 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded product | product | ad56d346431e… | cc804d4bbf1e… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 58118-0598-8 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded product | product | 367a005e9d99… | 383a685ebd0f… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 58118-0598-8 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded product | product | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 58118-0598-8 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded product | product | 8af77b9d5b6f… | d9bbb34c5368… | |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded package | package | 58118-0598-8 | 8af77b9d5b6f… | d9bbb34c5368… |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded product | product | 834df4deac94… | adcc014656a3… | |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded package | package | 58118-0598-8 | 834df4deac94… | adcc014656a3… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded product | product | 1332a3947898… | d4bfe170f9cd… | |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded package | package | 58118-0598-8 | 1332a3947898… | d4bfe170f9cd… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A202433-001 | TAMSULOSIN HYDROCHLORIDE | TAMSULOSIN HYDROCHLORIDE | 0.4MG | CAPSULE / ORAL | AB | 2013-04-30 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A202433-001 | 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 | A202433-001 | TAMSULOSIN HYDROCHLORIDE | 0.4MG | CAPSULE / ORAL | AB | 2013-04-30 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202433-001 | TAMSULOSIN HYDROCHLORIDE | 0.4MG | CAPSULE / ORAL | AB | 2013-04-30 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202433-001 | TAMSULOSIN HYDROCHLORIDE | 0.4MG | CAPSULE / ORAL | AB | 2013-04-30 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202433-001 | TAMSULOSIN HYDROCHLORIDE | 0.4MG | CAPSULE / ORAL | AB | 2013-04-30 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202433-001 | TAMSULOSIN HYDROCHLORIDE | 0.4MG | CAPSULE / ORAL | AB | 2013-04-30 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202433-001 | TAMSULOSIN HYDROCHLORIDE | 0.4MG | CAPSULE / ORAL | AB | 2013-04-30 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202433-001 | TAMSULOSIN HYDROCHLORIDE | 0.4MG | CAPSULE / ORAL | AB | 2013-04-30 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202433-001 | TAMSULOSIN HYDROCHLORIDE | 0.4MG | CAPSULE / ORAL | AB | 2013-04-30 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202433-001 | TAMSULOSIN HYDROCHLORIDE | 0.4MG | CAPSULE / ORAL | AB | 2013-04-30 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A202433-001 | TAMSULOSIN HYDROCHLORIDE | 0.4MG | CAPSULE / ORAL | AB | 2013-04-30 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A202433-001 | TAMSULOSIN HYDROCHLORIDE | 0.4MG | CAPSULE / ORAL | AB | 2013-04-30 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A202433-001 | TAMSULOSIN HYDROCHLORIDE | 0.4MG | CAPSULE / ORAL | AB | 2013-04-30 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A202433-001 | TAMSULOSIN HYDROCHLORIDE | 0.4MG | CAPSULE / ORAL | AB | 2013-04-30 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A202433-001 | TAMSULOSIN HYDROCHLORIDE | 0.4MG | CAPSULE / ORAL | AB | 2013-04-30 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A202433-001 | TAMSULOSIN HYDROCHLORIDE | 0.4MG | CAPSULE / ORAL | AB | 2013-04-30 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A202433-001 | TAMSULOSIN HYDROCHLORIDE | 0.4MG | CAPSULE / ORAL | AB | 2013-04-30 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A202433-001 | TAMSULOSIN HYDROCHLORIDE | 0.4MG | CAPSULE / ORAL | AB | 2013-04-30 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A202433-001 | TAMSULOSIN HYDROCHLORIDE | 0.4MG | CAPSULE / ORAL | AB | 2013-04-30 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A202433-001 | TAMSULOSIN HYDROCHLORIDE | 0.4MG | CAPSULE / ORAL | AB | 2013-04-30 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A202433-001 | TAMSULOSIN HYDROCHLORIDE | 0.4MG | CAPSULE / ORAL | AB | 2013-04-30 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A202433-001 | TAMSULOSIN HYDROCHLORIDE | 0.4MG | CAPSULE / ORAL | AB | 2013-04-30 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | A202433-001 | TAMSULOSIN HYDROCHLORIDE | 0.4MG | CAPSULE / ORAL | AB | 2013-04-30 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | A202433-001 | TAMSULOSIN HYDROCHLORIDE | 0.4MG | CAPSULE / ORAL | AB | 2013-04-30 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | A202433-001 | TAMSULOSIN HYDROCHLORIDE | 0.4MG | CAPSULE / ORAL | AB | 2013-04-30 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | A202433-001 | TAMSULOSIN HYDROCHLORIDE | 0.4MG | CAPSULE / ORAL | AB | 2013-04-30 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | A202433-001 | TAMSULOSIN HYDROCHLORIDE | 0.4MG | CAPSULE / ORAL | AB | 2013-04-30 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | A202433-001 | TAMSULOSIN HYDROCHLORIDE | 0.4MG | CAPSULE / ORAL | AB | 2013-04-30 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A202433-001 | TAMSULOSIN HYDROCHLORIDE | 0.4MG | CAPSULE / ORAL | AB | 2013-04-30 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | A202433-001 | TAMSULOSIN HYDROCHLORIDE | 0.4MG | CAPSULE / ORAL | AB | 2013-04-30 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | A202433-001 | TAMSULOSIN HYDROCHLORIDE | 0.4MG | CAPSULE / ORAL | AB | 2013-04-30 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A202433-001 | TAMSULOSIN HYDROCHLORIDE | 0.4MG | CAPSULE / ORAL | AB | 2013-04-30 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A202433-001 | TAMSULOSIN HYDROCHLORIDE | 0.4MG | CAPSULE / ORAL | AB | 2013-04-30 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A202433-001 | TAMSULOSIN HYDROCHLORIDE | 0.4MG | CAPSULE / ORAL | AB | 2013-04-30 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A202433-001 | TAMSULOSIN HYDROCHLORIDE | 0.4MG | CAPSULE / ORAL | AB | 2013-04-30 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | A202433-001 | TAMSULOSIN HYDROCHLORIDE | 0.4MG | CAPSULE / ORAL | AB | 2013-04-30 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | A202433-001 | TAMSULOSIN HYDROCHLORIDE | 0.4MG | CAPSULE / ORAL | AB | 2013-04-30 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A202433-001 | TAMSULOSIN HYDROCHLORIDE | 0.4MG | CAPSULE / ORAL | AB | 2013-04-30 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | A202433-001 | TAMSULOSIN HYDROCHLORIDE | 0.4MG | CAPSULE / ORAL | AB | 2013-04-30 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | A202433-001 | TAMSULOSIN HYDROCHLORIDE | 0.4MG | CAPSULE / ORAL | AB | 2013-04-30 | e64feba35796… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A202433-001 | TAMSULOSIN HYDROCHLORIDE | 0.4MG | CAPSULE / ORAL | AB | 2013-04-30 | cb3db0bc1861… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A202433-001 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202433-001 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A202433-001 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202433-001 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202433-001 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202433-001 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202433-001 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202433-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202433-001 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A202433-001 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A202433-001 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A202433-001 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A202433-001 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A202433-001 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A202433-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A202433-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A202433-001 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A202433-001 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A202433-001 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A202433-001 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A202433-001 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A202433-001 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A202433-001 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A202433-001 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A202433-001 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A202433-001 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A202433-001 | AB | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A202433-001 | AB | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A202433-001 | AB | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A202433-001 | AB | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A202433-001 | AB | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A202433-001 | AB | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A202433-001 | AB | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A202433-001 | AB | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A202433-001 | AB | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A202433-001 | AB | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A202433-001 | AB | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A202433-001 | AB | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | A202433-001 | AB | 1 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A202433-001 | AB | 1 | cb3db0bc1861… |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| ee39297f-c54b-4394-13fa-e0de7b5b9070 | Product name | 4 | 20250305 |
| 6c13b22c-b3ba-4127-b768-0132dd5ab0d1 | Product name | 1 | 20230829 |
| 594e2c86-3079-4e6e-96c9-48f7a8afc78d | Product name | 1 | 20230718 |
| ae349df8-97ce-a639-ed32-50a4cb01b1bd | Product name | 4 | 20200313 |
| 7792dadb-52b6-46b6-8fdf-80b1171065b5 | Product name | 1 | 20180810 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 58118-0598-8 | 2024-01-30 | C162847 | 48780-1 | 1030e365-2d46-111a-e063-dadaa90a10e2 | These highlights do not include all the information needed to use TAMSULOSIN HYDROCHLORIDE CAPSULES safely and effectively. See full prescribing information for TAMSULOSIN HYDROCHLORIDE CAPSULES. TAMSULOSIN HYDROCHLORIDE capsules, for oral use Initial U.S. Approval: 1997 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 58118-0598-8 | Tamsulosin Hydrochloride | 30 in 1 BLISTER PACK | CAPSULE | 30 | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 58118-0598 | TAMSULOSIN HYDROCHLORIDE CAPSULE [CLINICAL SOLUTIONS WHOLESALE, LLC] | 2 | Legacy NDC, 1 package rows | 20200926_14c1fc86-76bd-499d-871a-e6830bea2322.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 |
|---|---|---|---|---|---|---|
| Tamsulosin Hydrochloride | TAMSULOSIN HYDROCHLORIDE | REMEDYREPACK INC. | a608ddc8-fe42-484e-b61f-307c60151138 | 2026-07-16 | Warnings, Adverse reactions | 202433 ANDA202433 |
| Tamsulosin Hydrochloride | TAMSULOSIN HYDROCHLORIDE | REMEDYREPACK INC. | b30e2bde-b20e-4899-a100-f44170d8165b | 2026-06-24 | Warnings, Adverse reactions | 202433 ANDA202433 |
| Tamsulosin Hydrochloride | TAMSULOSIN HYDROCHLORIDE | Bryant Ranch Prepack | 59d0e07c-0018-4681-beb2-cb1c8e2637ee | 2026-05-14 | Warnings, Adverse reactions | 202433 ANDA202433 |
| Tamsulosin Hydrochloride | TAMSULOSIN HYDROCHLORIDE | St. Marys Medical Park Pharmacy | 6142d7b6-e5ea-1af0-e053-2991aa0a00cd | 2026-05-05 | Warnings, Adverse reactions | 202433 ANDA202433 |
| TAMSULOSIN HYDROCHLORIDE | TAMSULOSIN HYDROCHLORIDE | DIRECT RX | 7a420aca-31e6-8e0c-e053-2a91aa0a1be0 | 2026-04-22 | Warnings, Adverse reactions | 202433 ANDA202433 |
| TAMSULOSIN HYDROCHLORIDE | TAMSULOSIN HYDROCHLORIDE | Direct_Rx | 8de50eca-8cc5-082d-e053-2a95a90a346d | 2026-04-13 | Warnings, Adverse reactions | 202433 ANDA202433 |
| Tamsulosin Hydrochloride | TAMSULOSIN HYDROCHLORIDE | Bryant Ranch Prepack | fd73ddfd-3773-45b2-9795-9e58744a6803 | 2026-03-19 | Warnings, Adverse reactions | 202433 ANDA202433 |
| Tamsulosin Hydrochloride | TAMSULOSIN HYDROCHLORIDE | Redpharm Drug | 4d481f6b-0232-d4af-e063-6394a90ad1af | 2026-03-18 | Warnings, Adverse reactions | 202433 ANDA202433 |
| Tamsulosin Hydrochloride | TAMSULOSIN HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | f543f5d1-3348-4066-99a4-7a00aee1530d | 2026-01-22 | Warnings, Adverse reactions | 202433 ANDA202433 |
| Tamsulosin Hydrochloride | TAMSULOSIN HYDROCHLORIDE | Rising Pharma Holdings, Inc. | a242c8dc-576e-4a1f-a9e7-a05d7ebc0e0a | 2026-01-05 | Warnings, Adverse reactions | 202433 ANDA202433 |
| Tamsulosin Hydrochloride | TAMSULOSIN HYDROCHLORIDE | Northwind Health Company, LLC | d9df4fe0-90ab-0d96-e053-2a95a90a5ff1 | 2026-01-01 | Warnings, Adverse reactions | 202433 ANDA202433 |
| Tamsulosin Hydrochloride | TAMSULOSIN HYDROCHLORIDE | Cardinal Health 107, LLC | 0e3206ba-db3e-40b3-b46b-c7ae4703fdea | 2025-10-30 | Warnings, Adverse reactions | 202433 ANDA202433 |
| Tamsulosin Hydrochloride | TAMSULOSIN HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | f6b6aeab-bedd-4254-8811-4f65cf8a351f | 2025-10-17 | Warnings, Adverse reactions | 202433 ANDA202433 |
| Tamsulosin Hydrochloride | TAMSULOSIN HYDROCHLORIDE | A-S Medication Solutions | 6a2a4cc7-c88a-4555-a247-d1e63206ffc5 | 2025-10-02 | Warnings, Adverse reactions | 202433 ANDA202433 |
| Tamsulosin Hydrochloride | TAMSULOSIN HYDROCHLORIDE | A-S Medication Solutions | 00bb2d71-1f21-494c-aa66-a82be3a0a8e6 | 2025-10-02 | Warnings, Adverse reactions | 202433 ANDA202433 |
| Tamsulosin Hydrochloride | TAMSULOSIN HYDROCHLORIDE | A-S Medication Solutions | 1d70b04e-ca08-48d3-937b-eb701b40dd8a | 2025-10-02 | Warnings, Adverse reactions | 202433 ANDA202433 |
| Tamsulosin Hydrochloride | TAMSULOSIN HYDROCHLORIDE | Preferred Pharmaceuticals, Inc. | 82d65964-de00-42c2-baaa-cc3de744b8eb | 2025-09-25 | Warnings, Adverse reactions | 202433 ANDA202433 |
| Tamsulosin Hydrochloride | TAMSULOSIN HYDROCHLORIDE | Major Pharmaceuticals | f8302a6e-b8da-4931-a279-b49e37943816 | 2025-09-23 | Warnings, Adverse reactions | 202433 ANDA202433 |
| Tamsulosin Hydrochloride | TAMSULOSIN HYDROCHLORIDE | Bryant Ranch Prepack | 36b8c36f-22e5-40f5-a99a-411115f13df4 | 2025-05-23 | Warnings, Adverse reactions | 202433 ANDA202433 |
| Tamsulosin Hydrochloride | TAMSULOSIN HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | cfd48327-a528-58cc-e053-2995a90a129f | 2025-02-10 | Warnings, Adverse reactions | 202433 ANDA202433 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 863669 | tamsulosin HCl 0.4 MG Oral Capsule | PSN | 14c1fc86-76bd-499d-871a-e6830bea2322 | 2 |
| 863669 | tamsulosin hydrochloride 0.4 MG Oral Capsule | SCD | 14c1fc86-76bd-499d-871a-e6830bea2322 | 2 |
| 863669 | tamsulosin HCl 0.4 MG Modified Release Oral Capsule | SY | 14c1fc86-76bd-499d-871a-e6830bea2322 | 2 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 58118-0598-8 | 58118059808 | 30 CAPSULE in 1 BLISTER PACK (58118-0598-8) | 30 capsule | 2019-11-19 | 0000-00-00 | No | No | Current |