Tamsulosin Hydrochloride

Product NDC
67296-1646
11-digit product format
672961646
Labeler code
67296
Product ID
67296-1646_b8df8cb5-10a0-58db-e053-2a95a90a8313
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tamsulosin Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
RedPharm Drug. Inc.
Application
ANDA207405
Marketing category
ANDA
Marketing start
2019-01-01
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
2022-12-31
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 productproduct67296-1646IInactivated by FDA2026-08-17
excluded productproduct67296-1646IInactivated by FDA2026-08-17
excluded packagepackage67296-164667296-1646-1IInactivated by FDA2026-08-17
excluded packagepackage67296-164667296-1646-7IInactivated by FDA2026-08-17
excluded packagepackage67296-164667296-1646-3IInactivated 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 · 12 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage67296-1646-1557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage67296-1646-7557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage67296-1646-18af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage67296-1646-78af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage67296-1646-1834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage67296-1646-7834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage67296-1646-11332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage67296-1646-71332a3947898…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
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…

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, Effective, Related label table
NDCEffectiveRelated label
67296-1646-12026-01-29Tamsulosin 0.4mg
67296-1646-72026-01-29Tamsulosin 0.4mg
67296-1646-12024-08-09Tamsulosin 0.4mg
67296-1646-72024-08-09Tamsulosin 0.4mg
67296-1646-12023-01-30Tamsulosin 0.4mg
67296-1646-72023-01-30Tamsulosin 0.4mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-1646-1Tamsulosin Hydrochloride10 in 1 BOTTLECAPSULE108
67296-1646-7Tamsulosin Hydrochloride7 in 1 BOTTLECAPSULE78
67296-1646-3Tamsulosin Hydrochloride30 in 1 BOTTLECAPSULE301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-1646TAMSULOSIN HYDROCHLORIDE CAPSULE [REDPHARM DRUG. INC.]8Legacy NDC, 2 package rows20240810_8902ff1a-8acb-465b-e053-2995a90a1ce4.zip
67296-1646TAMSULOSIN HYDROCHLORIDE CAPSULE [REDPHARM DRUG. INC.]1Legacy NDC, 1 package rows20240810_f4c298d5-affb-7b56-e053-2a95a90a3d55.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 · 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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
863669tamsulosin HCl 0.4 MG Oral CapsulePSN8902ff1a-8acb-465b-e053-2995a90a1ce48
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCD8902ff1a-8acb-465b-e053-2995a90a1ce48
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSY8902ff1a-8acb-465b-e053-2995a90a1ce48
863669tamsulosin HCl 0.4 MG Oral CapsulePSNf4c298d5-affb-7b56-e053-2a95a90a3d551
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCDf4c298d5-affb-7b56-e053-2a95a90a3d551
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSYf4c298d5-affb-7b56-e053-2a95a90a3d551

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67296-1646-16729616460110 CAPSULE in 1 BOTTLE (67296-1646-1) 10 capsule2019-01-010000-00-00NoNoCurrent
67296-1646-36729616460330 in 1 BOTTLEHistorical
67296-1646-7672961646077 CAPSULE in 1 BOTTLE (67296-1646-7) 7 capsule2019-01-010000-00-00NoNoCurrent