Tamsulosin Hydrochloride

Product NDC
53217-154
11-digit product format
532170154
Labeler code
53217
Product ID
53217-154_c814a14d-9200-4a65-bbfb-9da05192d2e0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tamsulosin Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA202433
Marketing category
ANDA
Marketing start
2013-04-30
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
2019-12-31
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.

Current NDC status page 1 of 1 · 5 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct53217-154IInactivated by FDA2026-08-17
excluded packagepackage53217-15453217-154-07IInactivated by FDA2026-08-17
excluded packagepackage53217-15453217-154-30IInactivated by FDA2026-08-17
excluded packagepackage53217-15453217-154-60IInactivated by FDA2026-08-17
excluded packagepackage53217-15453217-154-90IInactivated by FDA2026-08-17

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.

Historic NDC status page 1 of 2 · 105 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage53217-154-07d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage53217-154-30d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage53217-154-90d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage53217-154-60d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage53217-154-07f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage53217-154-30f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage53217-154-90f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage53217-154-60f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage53217-154-072ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage53217-154-302ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage53217-154-902ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage53217-154-602ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage53217-154-07a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage53217-154-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage53217-154-90a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage53217-154-60a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage53217-154-07cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage53217-154-30cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage53217-154-90cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage53217-154-60cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage53217-154-07cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage53217-154-30cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage53217-154-90cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage53217-154-60cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage53217-154-07302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage53217-154-30302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage53217-154-90302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage53217-154-60302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage53217-154-07ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage53217-154-30ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage53217-154-90ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage53217-154-60ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage53217-154-070efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage53217-154-300efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage53217-154-900efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage53217-154-600efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage53217-154-07ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage53217-154-30ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage53217-154-90ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage53217-154-60ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage53217-154-07367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage53217-154-30367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage53217-154-90367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage53217-154-60367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage53217-154-07557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage53217-154-30557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage53217-154-90557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage53217-154-60557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A202433-001TAMSULOSIN HYDROCHLORIDETAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2013-04-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A202433-001AB

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.

Product history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A202433-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2013-04-30caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A202433-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2013-04-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202433-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2013-04-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A202433-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2013-04-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202433-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2013-04-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202433-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2013-04-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202433-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2013-04-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202433-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2013-04-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202433-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2013-04-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202433-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2013-04-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202433-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2013-04-30d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202433-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2013-04-3079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202433-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2013-04-30301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202433-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2013-04-301e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202433-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2013-04-308072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202433-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2013-04-305c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A202433-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2013-04-305d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A202433-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2013-04-304b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A202433-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2013-04-3074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A202433-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2013-04-30bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A202433-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2013-04-30782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A202433-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2013-04-3087673890dc5c…
2021-03-12 10:30 UTC2021-03A202433-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2013-04-305aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A202433-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2013-04-308869cabd3fbd…
2020-11-12 02:37 UTC2020-11A202433-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2013-04-30c0c555d07b60…
2019-12-14 00:12 UTC2019-12A202433-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2013-04-303f01610625f2…
2019-09-15 20:21 UTC2019-09A202433-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2013-04-30b00525d2431f…
2019-07-19 19:46 UTC2019-07A202433-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2013-04-30ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A202433-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2013-04-306a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A202433-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2013-04-301c564ffb4f44…
2023-12-20 04:57 UTC2023-12A202433-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2013-04-30ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A202433-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2013-04-30a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A202433-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2013-04-309b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A202433-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2013-04-30a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A202433-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2013-04-303f0d92c62455…
2023-05-13 08:27 UTC2023-05A202433-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2013-04-30053a50430f4f…
2023-01-26 05:58 UTC2023-01A202433-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2013-04-303bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A202433-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2013-04-303a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A202433-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2013-04-30f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A202433-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2013-04-30e64feba35796…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A202433-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A202433-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202433-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A202433-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202433-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202433-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202433-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202433-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202433-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202433-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202433-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202433-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202433-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202433-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202433-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202433-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A202433-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A202433-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A202433-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A202433-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A202433-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A202433-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A202433-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A202433-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A202433-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A202433-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A202433-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A202433-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A202433-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A202433-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A202433-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A202433-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A202433-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A202433-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A202433-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A202433-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A202433-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A202433-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A202433-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A202433-001AB1e64feba35796…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ee39297f-c54b-4394-13fa-e0de7b5b9070Product name420250305
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
ae349df8-97ce-a639-ed32-50a4cb01b1bdProduct name420200313

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53217-154-07Tamsulosin Hydrochloride7 in 1 BOTTLECAPSULE71
53217-154-30Tamsulosin Hydrochloride30 in 1 BOTTLECAPSULE301
53217-154-60Tamsulosin Hydrochloride60 in 1 BOTTLECAPSULE601
53217-154-90Tamsulosin Hydrochloride90 in 1 BOTTLECAPSULE901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53217-154-07EA - Each53217-1542d7d8f91-c0ad-4457-90f3-9627a36dcc8d12017-03-06
53217-154-30EA - Each53217-154a0b97b37-5b50-45c8-93dc-812d4d08ed4312017-03-06
53217-154-90EA - Each53217-1547d8134f5-5c27-4359-ab4f-d7f001dee07312017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53217-154TAMSULOSIN HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 4 package rows20170221_3d06b06c-e28f-44ea-914c-6c9393e32f58.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.

Matched openFDA labels page 1 of 2 · 32 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tamsulosin HydrochlorideTAMSULOSIN HYDROCHLORIDEREMEDYREPACK INC.a608ddc8-fe42-484e-b61f-307c601511382026-07-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202433
application number: ANDA202433
Tamsulosin HydrochlorideTAMSULOSIN HYDROCHLORIDEREMEDYREPACK INC.b30e2bde-b20e-4899-a100-f44170d8165b2026-06-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202433
application number: ANDA202433
Tamsulosin HydrochlorideTAMSULOSIN HYDROCHLORIDEBryant Ranch Prepack59d0e07c-0018-4681-beb2-cb1c8e2637ee2026-05-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202433
application number: ANDA202433
Tamsulosin HydrochlorideTAMSULOSIN HYDROCHLORIDESt. Marys Medical Park Pharmacy6142d7b6-e5ea-1af0-e053-2991aa0a00cd2026-05-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202433
application number: ANDA202433
TAMSULOSIN HYDROCHLORIDETAMSULOSIN HYDROCHLORIDEDIRECT RX7a420aca-31e6-8e0c-e053-2a91aa0a1be02026-04-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202433
application number: ANDA202433
TAMSULOSIN HYDROCHLORIDETAMSULOSIN HYDROCHLORIDEDirect_Rx8de50eca-8cc5-082d-e053-2a95a90a346d2026-04-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202433
application number: ANDA202433
Tamsulosin HydrochlorideTAMSULOSIN HYDROCHLORIDEBryant Ranch Prepackfd73ddfd-3773-45b2-9795-9e58744a68032026-03-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202433
application number: ANDA202433
Tamsulosin HydrochlorideTAMSULOSIN HYDROCHLORIDERedpharm Drug4d481f6b-0232-d4af-e063-6394a90ad1af2026-03-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202433
application number: ANDA202433
Tamsulosin HydrochlorideTAMSULOSIN HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.f543f5d1-3348-4066-99a4-7a00aee1530d2026-01-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202433
application number: ANDA202433
Tamsulosin HydrochlorideTAMSULOSIN HYDROCHLORIDERising Pharma Holdings, Inc.a242c8dc-576e-4a1f-a9e7-a05d7ebc0e0a2026-01-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202433
application number: ANDA202433
Tamsulosin HydrochlorideTAMSULOSIN HYDROCHLORIDENorthwind Health Company, LLCd9df4fe0-90ab-0d96-e053-2a95a90a5ff12026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202433
application number: ANDA202433
Tamsulosin HydrochlorideTAMSULOSIN HYDROCHLORIDECardinal Health 107, LLC0e3206ba-db3e-40b3-b46b-c7ae4703fdea2025-10-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202433
application number: ANDA202433
Tamsulosin HydrochlorideTAMSULOSIN HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.f6b6aeab-bedd-4254-8811-4f65cf8a351f2025-10-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202433
application number: ANDA202433
Tamsulosin HydrochlorideTAMSULOSIN HYDROCHLORIDEA-S Medication Solutions6a2a4cc7-c88a-4555-a247-d1e63206ffc52025-10-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202433
application number: ANDA202433
Tamsulosin HydrochlorideTAMSULOSIN HYDROCHLORIDEA-S Medication Solutions00bb2d71-1f21-494c-aa66-a82be3a0a8e62025-10-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202433
application number: ANDA202433
Tamsulosin HydrochlorideTAMSULOSIN HYDROCHLORIDEA-S Medication Solutions1d70b04e-ca08-48d3-937b-eb701b40dd8a2025-10-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202433
application number: ANDA202433
Tamsulosin HydrochlorideTAMSULOSIN HYDROCHLORIDEPreferred Pharmaceuticals, Inc.82d65964-de00-42c2-baaa-cc3de744b8eb2025-09-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202433
application number: ANDA202433
Tamsulosin HydrochlorideTAMSULOSIN HYDROCHLORIDEMajor Pharmaceuticalsf8302a6e-b8da-4931-a279-b49e379438162025-09-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202433
application number: ANDA202433
Tamsulosin HydrochlorideTAMSULOSIN HYDROCHLORIDEBryant Ranch Prepack36b8c36f-22e5-40f5-a99a-411115f13df42025-05-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202433
application number: ANDA202433
Tamsulosin HydrochlorideTAMSULOSIN HYDROCHLORIDENuCare Pharmaceuticals,Inc.cfd48327-a528-58cc-e053-2995a90a129f2025-02-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202433
application number: ANDA202433

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
863669tamsulosin HCl 0.4 MG Oral CapsulePSN3d06b06c-e28f-44ea-914c-6c9393e32f581
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCD3d06b06c-e28f-44ea-914c-6c9393e32f581
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSY3d06b06c-e28f-44ea-914c-6c9393e32f581

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53217-154-07532170154077 in 1 BOTTLEHistorical
53217-154-305321701543030 in 1 BOTTLEHistorical
53217-154-605321701546060 in 1 BOTTLEHistorical
53217-154-905321701549090 in 1 BOTTLEHistorical