Tamsulosin Hydrochloride
- Product NDC
- 63739-567
- 11-digit product format
- 637390567
- Labeler code
- 63739
- Product ID
- 63739-567_e27141f5-20a2-2be9-e053-2995a90a4ef0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tamsulosin Hydrochloride
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- McKesson Corporation dba SKY Packaging
- Application
- ANDA078225
- Marketing category
- ANDA
- Marketing start
- 2010-04-27
- 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
- 2023-12-31
- 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 | 63739-567 | D | Discontinued by firm | 2026-08-17 | ||
| excluded package | package | 63739-567 | 63739-567-10 | 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 |
|---|---|---|---|---|---|---|---|
| A078225-001 | TAMSULOSIN HYDROCHLORIDE | TAMSULOSIN HYDROCHLORIDE | 0.4MG | CAPSULE / ORAL | AB | RS | 2010-04-27 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A078225-001 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A078225-001 | TAMSULOSIN HYDROCHLORIDE | 0.4MG | CAPSULE / ORAL | AB | RS | 2010-04-27 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A078225-001 | TAMSULOSIN HYDROCHLORIDE | 0.4MG | CAPSULE / ORAL | AB | RS | 2010-04-27 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078225-001 | TAMSULOSIN HYDROCHLORIDE | 0.4MG | CAPSULE / ORAL | AB | RS | 2010-04-27 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A078225-001 | TAMSULOSIN HYDROCHLORIDE | 0.4MG | CAPSULE / ORAL | AB | RS | 2010-04-27 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078225-001 | TAMSULOSIN HYDROCHLORIDE | 0.4MG | CAPSULE / ORAL | AB | RS | 2010-04-27 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078225-001 | TAMSULOSIN HYDROCHLORIDE | 0.4MG | CAPSULE / ORAL | AB | 2010-04-27 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078225-001 | TAMSULOSIN HYDROCHLORIDE | 0.4MG | CAPSULE / ORAL | AB | 2010-04-27 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078225-001 | TAMSULOSIN HYDROCHLORIDE | 0.4MG | CAPSULE / ORAL | AB | 2010-04-27 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078225-001 | TAMSULOSIN HYDROCHLORIDE | 0.4MG | CAPSULE / ORAL | AB | 2010-04-27 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078225-001 | TAMSULOSIN HYDROCHLORIDE | 0.4MG | CAPSULE / ORAL | AB | 2010-04-27 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078225-001 | TAMSULOSIN HYDROCHLORIDE | 0.4MG | CAPSULE / ORAL | AB | 2010-04-27 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078225-001 | TAMSULOSIN HYDROCHLORIDE | 0.4MG | CAPSULE / ORAL | AB | 2010-04-27 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078225-001 | TAMSULOSIN HYDROCHLORIDE | 0.4MG | CAPSULE / ORAL | AB | 2010-04-27 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078225-001 | TAMSULOSIN HYDROCHLORIDE | 0.4MG | CAPSULE / ORAL | AB | 2010-04-27 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A078225-001 | TAMSULOSIN HYDROCHLORIDE | 0.4MG | CAPSULE / ORAL | AB | 2010-04-27 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A078225-001 | TAMSULOSIN HYDROCHLORIDE | 0.4MG | CAPSULE / ORAL | AB | 2010-04-27 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A078225-001 | TAMSULOSIN HYDROCHLORIDE | 0.4MG | CAPSULE / ORAL | AB | 2010-04-27 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A078225-001 | TAMSULOSIN HYDROCHLORIDE | 0.4MG | CAPSULE / ORAL | AB | 2010-04-27 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A078225-001 | TAMSULOSIN HYDROCHLORIDE | 0.4MG | CAPSULE / ORAL | AB | 2010-04-27 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A078225-001 | TAMSULOSIN HYDROCHLORIDE | 0.4MG | CAPSULE / ORAL | AB | 2010-04-27 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A078225-001 | TAMSULOSIN HYDROCHLORIDE | 0.4MG | CAPSULE / ORAL | AB | 2010-04-27 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A078225-001 | TAMSULOSIN HYDROCHLORIDE | 0.4MG | CAPSULE / ORAL | AB | 2010-04-27 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | A078225-001 | TAMSULOSIN HYDROCHLORIDE | 0.4MG | CAPSULE / ORAL | AB | 2010-04-27 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | A078225-001 | TAMSULOSIN HYDROCHLORIDE | 0.4MG | CAPSULE / ORAL | AB | 2010-04-27 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | A078225-001 | TAMSULOSIN HYDROCHLORIDE | 0.4MG | CAPSULE / ORAL | AB | 2010-04-27 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | A078225-001 | TAMSULOSIN HYDROCHLORIDE | 0.4MG | CAPSULE / ORAL | AB | 2010-04-27 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | A078225-001 | TAMSULOSIN HYDROCHLORIDE | 0.4MG | CAPSULE / ORAL | AB | 2010-04-27 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | A078225-001 | TAMSULOSIN HYDROCHLORIDE | 0.4MG | CAPSULE / ORAL | AB | 2010-04-27 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A078225-001 | TAMSULOSIN HYDROCHLORIDE | 0.4MG | CAPSULE / ORAL | AB | 2010-04-27 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | A078225-001 | TAMSULOSIN HYDROCHLORIDE | 0.4MG | CAPSULE / ORAL | AB | 2010-04-27 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | A078225-001 | TAMSULOSIN HYDROCHLORIDE | 0.4MG | CAPSULE / ORAL | AB | 2010-04-27 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A078225-001 | TAMSULOSIN HYDROCHLORIDE | 0.4MG | CAPSULE / ORAL | AB | 2010-04-27 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A078225-001 | TAMSULOSIN HYDROCHLORIDE | 0.4MG | CAPSULE / ORAL | AB | 2010-04-27 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A078225-001 | TAMSULOSIN HYDROCHLORIDE | 0.4MG | CAPSULE / ORAL | AB | 2010-04-27 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A078225-001 | TAMSULOSIN HYDROCHLORIDE | 0.4MG | CAPSULE / ORAL | AB | 2010-04-27 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | A078225-001 | TAMSULOSIN HYDROCHLORIDE | 0.4MG | CAPSULE / ORAL | AB | 2010-04-27 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | A078225-001 | TAMSULOSIN HYDROCHLORIDE | 0.4MG | CAPSULE / ORAL | AB | 2010-04-27 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A078225-001 | TAMSULOSIN HYDROCHLORIDE | 0.4MG | CAPSULE / ORAL | AB | 2010-04-27 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | A078225-001 | TAMSULOSIN HYDROCHLORIDE | 0.4MG | CAPSULE / ORAL | AB | 2010-04-27 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | A078225-001 | TAMSULOSIN HYDROCHLORIDE | 0.4MG | CAPSULE / ORAL | AB | 2010-04-27 | e64feba35796… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A078225-001 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A078225-001 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078225-001 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A078225-001 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078225-001 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078225-001 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078225-001 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078225-001 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078225-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078225-001 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A078225-001 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078225-001 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078225-001 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078225-001 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A078225-001 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A078225-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A078225-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A078225-001 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A078225-001 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A078225-001 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A078225-001 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A078225-001 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A078225-001 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A078225-001 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A078225-001 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A078225-001 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A078225-001 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A078225-001 | AB | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A078225-001 | AB | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A078225-001 | AB | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A078225-001 | AB | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A078225-001 | AB | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A078225-001 | AB | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A078225-001 | AB | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A078225-001 | AB | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A078225-001 | AB | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A078225-001 | AB | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A078225-001 | AB | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A078225-001 | AB | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | A078225-001 | AB | 1 | e64feba35796… |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 63739-567-10 | 2020-07-22 | C162847 | 48780-1 | ab0e2407-33e5-f274-e053-dbdaa90a6471 | 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 USP, for oral use Initial U.S. Approval: 1997 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 63739-567-10 | EA - Each | 63739-567 | ddc145ce-9438-45fa-9413-5017df468040 | 1 | 2013-02-13 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
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 | Preferred Pharmaceuticals Inc. | e4202c52-be9d-41d9-b5ff-122740298544 | 2026-08-12 | Warnings, Adverse reactions | 078225 ANDA078225 |
| Tamsulosin Hydrochloride | TAMSULOSIN HYDROCHLORIDE | Bryant Ranch Prepack | e9372720-bd02-e4a6-0afd-42fe0c661c00 | 2026-07-06 | Warnings, Adverse reactions | 078225 ANDA078225 |
| Tamsulosin Hydrochloride | TAMSULOSIN HYDROCHLORIDE | Cardinal Health 107, LLC | 5ed219aa-cf65-457f-8570-d26b48edb240 | 2026-06-17 | Warnings, Adverse reactions | 078225 ANDA078225 |
| Tamsulosin Hydrochloride | TAMSULOSIN HYDROCHLORIDE | Coupler LLC | 52bbe73b-43b6-3393-e063-6294a90a6dc6 | 2026-05-26 | Warnings, Adverse reactions | 078225 ANDA078225 |
| Tamsulosin Hydrochloride | TAMSULOSIN HYDROCHLORIDE | American Health Packaging | 8150a710-aee5-4841-ae1b-7d2e61281a8f | 2025-07-01 | Warnings, Adverse reactions | 078225 ANDA078225 |
| Tamsulosin Hydrochloride | TAMSULOSIN HYDROCHLORIDE | Zydus Lifesciences Limited | 276c7e26-f86a-46b9-b626-ceef76b729a4 | 2024-08-12 | 078225 ANDA078225 | |
| Tamsulosin Hydrochloride | TAMSULOSIN HYDROCHLORIDE | Zydus Pharmaceuticals USA Inc. | 300be29a-c56d-4daa-ba89-f207c281ea20 | 2023-11-08 | Warnings, Adverse reactions | 078225 ANDA078225 |
| Tamsulosin Hydrochloride | TAMSULOSIN HYDROCHLORIDE | Quallent Pharmaceuticals Health LLC | 12ba3063-a134-41e2-8447-45933d4f0f58 | 2023-09-18 | Warnings, Adverse reactions | 078225 ANDA078225 |
| Tamsulosin Hydrochloride | TAMSULOSIN HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | c963384e-eb50-4462-9aea-ed9d26d267d6 | 2023-08-14 | Warnings, Adverse reactions | 078225 ANDA078225 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 63739-567-10 | 63739056710 | 10 BLISTER PACK in 1 BOX, UNIT-DOSE (63739-567-10) > 10 CAPSULE in 1 BLISTER PACK | 10 blister pack | 2010-04-27 | 0000-00-00 | No | No | Current |