Tamsulosin Hydrochloride

Product NDC
51407-879
11-digit product format
514070879
Labeler code
51407
Product ID
51407-879_4111b93f-a496-1835-e063-6294a90a798b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tamsulosin Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Golden State Medical Supply, Inc.
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
18e9741b-969a-5a87-e063-6294a90a8851Available 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
51407-879-90Tamsulosin Hydrochloride90 in 1 BOTTLECAPSULE902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51407-879-90EA - Each51407-8792ef8780c-262f-4297-938c-e230d797975612024-06-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51407-879TAMSULOSIN HYDROCHLORIDE CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]1Current NDC, 1 package rows20240522_18e9741b-969a-5a87-e063-6294a90a8851.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
ndc (product): 51407-879
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 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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51407-879-905140708799090 CAPSULE in 1 BOTTLE (51407-879-90) 90 capsule2024-05-08NoNoCurrent