Tamsulosin Hydrochloride

Product NDC
67877-450
11-digit product format
678770450
Labeler code
67877
Product ID
67877-450_6803a320-4e6f-4f1a-bfcf-955daf90fa76
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tamsulosin Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Ascend Laboratories, LLC
Application
ANDA207405
Marketing category
ANDA
Marketing start
2017-08-11
Substance
TAMSULOSIN HYDROCHLORIDE
Active strength
.4 mg/1
Pharmacologic classes
Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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…

Additional Listing Data#

Finished product
Yes
Brand name base
Tamsulosin Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TAMSULOSIN HYDROCHLORIDE.4 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
11SV1951MRInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
863669Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
ed9988bc-0759-4c36-bee1-11b68dc1c84cAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ee39297f-c54b-4394-13fa-e0de7b5b9070Product name420250305
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
ae349df8-97ce-a639-ed32-50a4cb01b1bdProduct name420200313

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67877-450-01Tamsulosin Hydrochloride100 in 1 BOTTLECAPSULE1009
67877-450-05Tamsulosin Hydrochloride500 in 1 BOTTLECAPSULE5009
67877-450-10Tamsulosin Hydrochloride1000 in 1 BOTTLECAPSULE10009
67877-450-30Tamsulosin Hydrochloride30 in 1 BOTTLECAPSULE309
67877-450-33Tamsulosin Hydrochloride10 in 1 BLISTER PACKCAPSULE109
67877-450-38Tamsulosin Hydrochloride10 in 1 CARTONCAPSULE109
67877-450-60Tamsulosin Hydrochloride60 in 1 BOTTLECAPSULE609

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67877-450-01EA - Each67877-450380493aa-204c-4620-ada4-5dae8c8a29b312017-10-13
67877-450-05EA - Each67877-4505d56455a-1491-489e-a7e3-2fceb9d4d0a712017-10-13
67877-450-10EA - Each67877-450c3a5aa5b-d650-4c12-a16b-c3f2857f902512017-10-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67877-450TAMSULOSIN HYDROCHLORIDE CAPSULE [ASCEND LABORATORIES, LLC]8Current NDC, Legacy NDC, 7 package rows20221014_ed9988bc-0759-4c36-bee1-11b68dc1c84c.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
ndc (product): 67877-450
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 CapsulePSNed9988bc-0759-4c36-bee1-11b68dc1c84c9
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCDed9988bc-0759-4c36-bee1-11b68dc1c84c9
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSYed9988bc-0759-4c36-bee1-11b68dc1c84c9
863669tamsulosin HCl 0.4 MG Oral CapsulePSN3a05970e-6c34-4dff-9fd7-dde8ce60f2808
863669tamsulosin HCl 0.4 MG Oral CapsulePSN8902ff1a-8acb-465b-e053-2995a90a1ce48
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCD3a05970e-6c34-4dff-9fd7-dde8ce60f2808
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCD8902ff1a-8acb-465b-e053-2995a90a1ce48
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSY3a05970e-6c34-4dff-9fd7-dde8ce60f2808
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSY8902ff1a-8acb-465b-e053-2995a90a1ce48
863669tamsulosin HCl 0.4 MG Oral CapsulePSNf185abfc-367d-45da-87c4-86d9f70bcd5d5
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCDf185abfc-367d-45da-87c4-86d9f70bcd5d5
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSYf185abfc-367d-45da-87c4-86d9f70bcd5d5
863669tamsulosin HCl 0.4 MG Oral CapsulePSN74a8ef78-908f-4671-91a3-ec3a044aabf24
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCD74a8ef78-908f-4671-91a3-ec3a044aabf24
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSY74a8ef78-908f-4671-91a3-ec3a044aabf24
863669tamsulosin HCl 0.4 MG Oral CapsulePSN06b44e53-c6e7-4e12-a8fd-572d092cfa703
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCD06b44e53-c6e7-4e12-a8fd-572d092cfa703
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSY06b44e53-c6e7-4e12-a8fd-572d092cfa703
863669tamsulosin HCl 0.4 MG Oral CapsulePSN18e9741b-969a-5a87-e063-6294a90a88512
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCD18e9741b-969a-5a87-e063-6294a90a88512
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSY18e9741b-969a-5a87-e063-6294a90a88512
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
67877-450-0167877045001100 CAPSULE in 1 BOTTLE (67877-450-01) 100 capsule2017-08-110000-00-00NoNoCurrent
67877-450-0567877045005500 CAPSULE in 1 BOTTLE (67877-450-05) 500 capsule2017-08-110000-00-00NoNoCurrent
67877-450-10678770450101000 CAPSULE in 1 BOTTLE (67877-450-10) 1000 capsule2017-08-110000-00-00NoNoCurrent
67877-450-306787704503030 CAPSULE in 1 BOTTLE (67877-450-30) 30 capsule2017-08-110000-00-00NoNoCurrent
67877-450-336787704503310 in 1 BLISTER PACKHistorical
67877-450-386787704503810 BLISTER PACK in 1 CARTON (67877-450-38) / 10 CAPSULE in 1 BLISTER PACK (67877-450-33) 10 blister pack2017-08-110000-00-00NoNoCurrent
67877-450-606787704506060 CAPSULE in 1 BOTTLE (67877-450-60) 60 capsule2017-08-110000-00-00NoNoCurrent