Tamsulosin Hydrochloride

Product NDC
70934-771
11-digit product format
709340771
Labeler code
70934
Product ID
70934-771_a97a1829-f629-2014-e053-2a95a90a8cc5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tamsulosin Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Denton Pharma, Inc. dba Northwind Pharmaceuticals
Application
ANDA207405
Marketing category
ANDA
Marketing start
2020-06-17
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.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct70934-771DDiscontinued by firm2026-08-17
excluded packagepackage70934-77170934-771-30DDiscontinued by firm2026-08-17

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 1 · 30 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage70934-771-30DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductDDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage70934-771-30DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductDDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage70934-771-30DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductDDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage70934-771-30DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductDDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage70934-771-30DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductDDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage70934-771-30DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductDDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage70934-771-30DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductDDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage70934-771-30DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductDDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage70934-771-30DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductDDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage70934-771-30DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductDDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage70934-771-30DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductDDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage70934-771-30DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductIInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage70934-771-30IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductIInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage70934-771-30IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductIInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage70934-771-30IInactivated by FDAbd6a592717d7…303034d00443…

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
A207405-001TAMSULOSIN HYDROCHLORIDETAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2017-08-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A207405-001AB

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 06:07:402026-07A207405-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2017-08-11caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A207405-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2017-08-11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207405-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2017-08-1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A207405-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2017-08-116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207405-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2017-08-11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207405-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2017-08-11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207405-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2017-08-1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207405-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2017-08-112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207405-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2017-08-115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207405-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2017-08-11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207405-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2017-08-11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207405-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2017-08-1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207405-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2017-08-11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207405-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2017-08-111e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207405-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2017-08-118072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207405-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2017-08-115c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A207405-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2017-08-115d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A207405-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2017-08-114b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A207405-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2017-08-1174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A207405-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2017-08-11bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A207405-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2017-08-11782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A207405-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2017-08-1187673890dc5c…
2021-03-12 10:30 UTC2021-03A207405-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2017-08-115aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A207405-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2017-08-118869cabd3fbd…
2020-11-12 02:37 UTC2020-11A207405-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2017-08-11c0c555d07b60…
2019-12-14 00:12 UTC2019-12A207405-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2017-08-113f01610625f2…
2019-09-15 20:21 UTC2019-09A207405-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2017-08-11b00525d2431f…
2019-07-19 19:46 UTC2019-07A207405-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2017-08-11ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A207405-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2017-08-116a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A207405-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2017-08-111c564ffb4f44…
2023-12-20 04:57 UTC2023-12A207405-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2017-08-11ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A207405-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2017-08-11a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A207405-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2017-08-119b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A207405-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2017-08-11a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A207405-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2017-08-113f0d92c62455…
2023-05-13 08:27 UTC2023-05A207405-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2017-08-11053a50430f4f…
2023-01-26 05:58 UTC2023-01A207405-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2017-08-113bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A207405-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2017-08-113a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A207405-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2017-08-11f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A207405-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2017-08-11e64feba35796…

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 06:07:402026-07A207405-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A207405-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207405-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A207405-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207405-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207405-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207405-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207405-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207405-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207405-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207405-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207405-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207405-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207405-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207405-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207405-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A207405-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A207405-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A207405-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A207405-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A207405-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A207405-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A207405-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A207405-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A207405-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A207405-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A207405-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A207405-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A207405-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A207405-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A207405-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A207405-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A207405-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A207405-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A207405-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A207405-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A207405-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A207405-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A207405-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A207405-001AB1e64feba35796…

FDA-Initiated Inactive NDC Indexing#

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 1 · 8 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tamsulosin HydrochlorideTAMSULOSIN HYDROCHLORIDEChartwell RX, LLC14db58df-7584-410b-8cf4-4b928dada8592025-12-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207405
application number: ANDA207405
Tamsulosin HydrochlorideTAMSULOSIN HYDROCHLORIDEAvPAK62fa7fdf-c588-6f79-e053-2a91aa0a4c192025-10-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207405
application number: ANDA207405
Tamsulosin HydrochlorideTAMSULOSIN HYDROCHLORIDEGolden State Medical Supply, Inc.18e9741b-969a-5a87-e063-6294a90a88512025-10-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207405
application number: ANDA207405
Tamsulosin HydrochlorideTAMSULOSIN HYDROCHLORIDEBryant Ranch Prepackf185abfc-367d-45da-87c4-86d9f70bcd5d2025-09-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207405
application number: ANDA207405
Tamsulosin HydrochlorideTAMSULOSIN HYDROCHLORIDEAscend Laboratories, LLCed9988bc-0759-4c36-bee1-11b68dc1c84c2025-08-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207405
application number: ANDA207405
Tamsulosin HydrochlorideTAMSULOSIN HYDROCHLORIDEA-S Medication Solutions3a05970e-6c34-4dff-9fd7-dde8ce60f2802023-10-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207405
application number: ANDA207405
Tamsulosin HydrochlorideTAMSULOSIN HYDROCHLORIDEA-S Medication Solutions74a8ef78-908f-4671-91a3-ec3a044aabf22023-09-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207405
application number: ANDA207405
Tamsulosin HydrochlorideTAMSULOSIN HYDROCHLORIDEProficient Rx LP06b44e53-c6e7-4e12-a8fd-572d092cfa702020-02-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207405
application number: ANDA207405

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70934-771-307093407713030 CAPSULE in 1 BOTTLE, PLASTIC (70934-771-30) 30 capsule2020-06-170000-00-00NoNoCurrent