Tamsulosin Hydrochloride

Product NDC
71335-0711
Requested package NDC
71335-0711-3
11-digit product format
713350711
Labeler code
71335
Product ID
71335-0711_48f57acf-24de-4415-8c42-f8c326091704
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tamsulosin Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA090931
Marketing category
ANDA
Marketing start
2010-07-15
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.

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

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage71335-071171335-0711-3IInactivated 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 1 · 15 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…

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
A090931-001TAMSULOSIN HYDROCHLORIDETAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORAL2010-07-15

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 06:07:402026-07A090931-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORAL2010-07-15caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090931-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORAL2010-07-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090931-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORAL2010-07-1531067a03dcf5…
2025-08-23 18:47 UTC2025-08A090931-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORAL2010-07-156a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090931-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORAL2010-07-15fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090931-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORAL2010-07-15b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090931-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORAL2010-07-1503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090931-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORAL2010-07-152680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090931-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2010-07-155bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090931-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORAL2010-07-15d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090931-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2010-07-15d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090931-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2010-07-1579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090931-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2010-07-15301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090931-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2010-07-151e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090931-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2010-07-158072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090931-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2010-07-155c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090931-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2010-07-155d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090931-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2010-07-154b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090931-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2010-07-1574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090931-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2010-07-15bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090931-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2010-07-15782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090931-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2010-07-1587673890dc5c…
2021-03-12 10:30 UTC2021-03A090931-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2010-07-155aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A090931-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2010-07-158869cabd3fbd…
2020-11-12 02:37 UTC2020-11A090931-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2010-07-15c0c555d07b60…
2019-12-14 00:12 UTC2019-12A090931-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2010-07-153f01610625f2…
2019-09-15 20:21 UTC2019-09A090931-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2010-07-15b00525d2431f…
2019-07-19 19:46 UTC2019-07A090931-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2010-07-15ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A090931-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2010-07-156a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A090931-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2010-07-151c564ffb4f44…
2023-12-20 04:57 UTC2023-12A090931-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2010-07-15ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A090931-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2010-07-15a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A090931-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2010-07-159b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A090931-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2010-07-15a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A090931-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2010-07-153f0d92c62455…
2023-05-13 08:27 UTC2023-05A090931-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2010-07-15053a50430f4f…
2023-01-26 05:58 UTC2023-01A090931-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2010-07-153bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A090931-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2010-07-153a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A090931-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2010-07-15f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A090931-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2010-07-15e64feba35796…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090931-001AB15bbf6a4d5a75…
2024-10-29 15:01 UTC2024-10A090931-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090931-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090931-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090931-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090931-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090931-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090931-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090931-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090931-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090931-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090931-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090931-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A090931-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A090931-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A090931-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A090931-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A090931-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A090931-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A090931-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A090931-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A090931-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A090931-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A090931-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A090931-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A090931-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A090931-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A090931-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A090931-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A090931-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A090931-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A090931-001AB1cb3db0bc1861…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ee39297f-c54b-4394-13fa-e0de7b5b9070Product name420250305
ae349df8-97ce-a639-ed32-50a4cb01b1bdProduct name420200313

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDCRelated label
71335-0711-1These highlights do not include all the information needed to use TAMSULOSIN HYDROCHLORIDE safely and effectively. See full prescribing information for TAMSULOSIN HYDROCHLORIDE CAPSULES. TAMSULOSIN HYDROCHLORIDE capsules, for oral use Initial U.S. Approval: 1997
71335-0711-2These highlights do not include all the information needed to use TAMSULOSIN HYDROCHLORIDE safely and effectively. See full prescribing information for TAMSULOSIN HYDROCHLORIDE CAPSULES. TAMSULOSIN HYDROCHLORIDE capsules, for oral use Initial U.S. Approval: 1997
71335-0711-3These highlights do not include all the information needed to use TAMSULOSIN HYDROCHLORIDE safely and effectively. See full prescribing information for TAMSULOSIN HYDROCHLORIDE CAPSULES. TAMSULOSIN HYDROCHLORIDE capsules, for oral use Initial U.S. Approval: 1997
71335-0711-4These highlights do not include all the information needed to use TAMSULOSIN HYDROCHLORIDE safely and effectively. See full prescribing information for TAMSULOSIN HYDROCHLORIDE CAPSULES. TAMSULOSIN HYDROCHLORIDE capsules, for oral use Initial U.S. Approval: 1997
71335-0711-5These highlights do not include all the information needed to use TAMSULOSIN HYDROCHLORIDE safely and effectively. See full prescribing information for TAMSULOSIN HYDROCHLORIDE CAPSULES. TAMSULOSIN HYDROCHLORIDE capsules, for oral use Initial U.S. Approval: 1997
71335-0711-6These highlights do not include all the information needed to use TAMSULOSIN HYDROCHLORIDE safely and effectively. See full prescribing information for TAMSULOSIN HYDROCHLORIDE CAPSULES. TAMSULOSIN HYDROCHLORIDE capsules, for oral use Initial U.S. Approval: 1997
71335-0711-7These highlights do not include all the information needed to use TAMSULOSIN HYDROCHLORIDE safely and effectively. See full prescribing information for TAMSULOSIN HYDROCHLORIDE CAPSULES. TAMSULOSIN HYDROCHLORIDE capsules, for oral use Initial U.S. Approval: 1997
71335-0711-8These highlights do not include all the information needed to use TAMSULOSIN HYDROCHLORIDE safely and effectively. See full prescribing information for TAMSULOSIN HYDROCHLORIDE CAPSULES. TAMSULOSIN HYDROCHLORIDE capsules, for oral use Initial U.S. Approval: 1997
71335-0711-9These highlights do not include all the information needed to use TAMSULOSIN HYDROCHLORIDE 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 table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-0711-1Tamsulosin Hydrochloride30 in 1 BOTTLECAPSULE304
71335-0711-2Tamsulosin Hydrochloride100 in 1 BOTTLECAPSULE1004
71335-0711-3Tamsulosin Hydrochloride60 in 1 BOTTLECAPSULE604
71335-0711-4Tamsulosin Hydrochloride10 in 1 BOTTLECAPSULE104
71335-0711-5Tamsulosin Hydrochloride90 in 1 BOTTLECAPSULE904
71335-0711-6Tamsulosin Hydrochloride180 in 1 BOTTLECAPSULE1804
71335-0711-7Tamsulosin Hydrochloride7 in 1 BOTTLECAPSULE74
71335-0711-8Tamsulosin Hydrochloride15 in 1 BOTTLECAPSULE154
71335-0711-9Tamsulosin Hydrochloride120 in 1 BOTTLECAPSULE1204

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0711-5EA - Each71335-071139ee1573-b4a9-4e49-b75b-33a284fdb61512022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0711TAMSULOSIN HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]4Legacy NDC, 9 package rows20220201_48f57acf-24de-4415-8c42-f8c326091704.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 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tamsulosin HydrochlorideTAMSULOSIN HYDROCHLORIDEProficient Rx LPbf583b4a-a99c-4e18-a6d1-8609b5db1a3a2021-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090931
application number: ANDA090931
Tamsulosin HydrochlorideTAMSULOSIN HYDROCHLORIDESun Pharmaceutical Industries, Inc.d742707b-4c17-4b08-a9d0-491ba2bf64152020-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090931
application number: ANDA090931

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
863669tamsulosin HCl 0.4 MG Oral CapsulePSN48f57acf-24de-4415-8c42-f8c3260917044
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCD48f57acf-24de-4415-8c42-f8c3260917044
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSY48f57acf-24de-4415-8c42-f8c3260917044

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-0711-37133507110360 CAPSULE in 1 BOTTLE (71335-0711-3) 60 capsule2022-01-270000-00-00NoNoCurrent