Tamsulosin Hydrochloride

Product NDC
0615-8055
11-digit product format
006158055
Labeler code
0615
Product ID
0615-8055_b5eec9b2-57b2-44f8-8117-3af64069e4d2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tamsulosin Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
NCS HealthCare of KY, LLC dba Vangard Labs
Application
ANDA202433
Marketing category
ANDA
Marketing start
2013-04-30
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 1.

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
A202433-001TAMSULOSIN HYDROCHLORIDETAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2013-04-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A202433-001AB

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 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A202433-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2013-04-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202433-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2013-04-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A202433-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2013-04-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202433-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2013-04-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202433-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2013-04-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202433-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2013-04-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202433-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2013-04-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202433-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2013-04-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202433-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2013-04-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202433-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2013-04-30d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202433-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2013-04-3079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202433-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2013-04-30301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202433-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2013-04-301e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202433-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2013-04-308072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202433-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2013-04-305c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A202433-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2013-04-305d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A202433-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2013-04-304b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A202433-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2013-04-3074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A202433-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2013-04-30bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A202433-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2013-04-30782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A202433-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2013-04-3087673890dc5c…
2021-03-12 10:30 UTC2021-03A202433-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2013-04-305aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A202433-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2013-04-308869cabd3fbd…
2020-11-12 02:37 UTC2020-11A202433-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2013-04-30c0c555d07b60…
2019-12-14 00:12 UTC2019-12A202433-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2013-04-303f01610625f2…
2019-09-15 20:21 UTC2019-09A202433-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2013-04-30b00525d2431f…
2019-07-19 19:46 UTC2019-07A202433-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2013-04-30ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A202433-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2013-04-306a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A202433-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2013-04-301c564ffb4f44…
2023-12-20 04:57 UTC2023-12A202433-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2013-04-30ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A202433-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2013-04-30a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A202433-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2013-04-309b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A202433-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2013-04-30a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A202433-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2013-04-303f0d92c62455…
2023-05-13 08:27 UTC2023-05A202433-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2013-04-30053a50430f4f…
2023-01-26 05:58 UTC2023-01A202433-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2013-04-303bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A202433-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2013-04-303a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A202433-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2013-04-30f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A202433-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2013-04-30e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A202433-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2013-04-30cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A202433-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202433-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A202433-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202433-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202433-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202433-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202433-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202433-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202433-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202433-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202433-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202433-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202433-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202433-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202433-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A202433-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A202433-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A202433-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A202433-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A202433-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A202433-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A202433-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A202433-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A202433-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A202433-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A202433-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A202433-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A202433-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A202433-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A202433-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A202433-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A202433-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A202433-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A202433-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A202433-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A202433-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A202433-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A202433-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A202433-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A202433-001AB1cb3db0bc1861…

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
503d080c-9db3-434a-add6-c7d0e5a0ab2eAvailable on FDA.report

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0615-8055-05Tamsulosin Hydrochloride15 in 1 BLISTER PACKCAPSULE1517
0615-8055-07Tamsulosin Hydrochloride7 in 1 BLISTER PACKCAPSULE717
0615-8055-14Tamsulosin Hydrochloride14 in 1 BLISTER PACKCAPSULE1417
0615-8055-28Tamsulosin Hydrochloride28 in 1 BLISTER PACKCAPSULE2817
0615-8055-30Tamsulosin Hydrochloride6 in 1 BOX, UNIT-DOSECAPSULE617
0615-8055-30Tamsulosin Hydrochloride5 in 1 BLISTER PACKCAPSULE517
0615-8055-39Tamsulosin Hydrochloride30 in 1 BLISTER PACKCAPSULE3017

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0615-8055TAMSULOSIN HYDROCHLORIDE CAPSULE [NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS]17Current NDC, Legacy NDC, 7 package rows20240921_503d080c-9db3-434a-add6-c7d0e5a0ab2e.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 2 · 32 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tamsulosin HydrochlorideTAMSULOSIN HYDROCHLORIDEREMEDYREPACK INC.a608ddc8-fe42-484e-b61f-307c601511382026-07-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202433
application number: ANDA202433
Tamsulosin HydrochlorideTAMSULOSIN HYDROCHLORIDEREMEDYREPACK INC.b30e2bde-b20e-4899-a100-f44170d8165b2026-06-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202433
application number: ANDA202433
Tamsulosin HydrochlorideTAMSULOSIN HYDROCHLORIDEBryant Ranch Prepack59d0e07c-0018-4681-beb2-cb1c8e2637ee2026-05-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202433
application number: ANDA202433
Tamsulosin HydrochlorideTAMSULOSIN HYDROCHLORIDESt. Marys Medical Park Pharmacy6142d7b6-e5ea-1af0-e053-2991aa0a00cd2026-05-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202433
application number: ANDA202433
TAMSULOSIN HYDROCHLORIDETAMSULOSIN HYDROCHLORIDEDIRECT RX7a420aca-31e6-8e0c-e053-2a91aa0a1be02026-04-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202433
application number: ANDA202433
TAMSULOSIN HYDROCHLORIDETAMSULOSIN HYDROCHLORIDEDirect_Rx8de50eca-8cc5-082d-e053-2a95a90a346d2026-04-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202433
application number: ANDA202433
Tamsulosin HydrochlorideTAMSULOSIN HYDROCHLORIDEBryant Ranch Prepackfd73ddfd-3773-45b2-9795-9e58744a68032026-03-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202433
application number: ANDA202433
Tamsulosin HydrochlorideTAMSULOSIN HYDROCHLORIDERedpharm Drug4d481f6b-0232-d4af-e063-6394a90ad1af2026-03-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202433
application number: ANDA202433
Tamsulosin HydrochlorideTAMSULOSIN HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.f543f5d1-3348-4066-99a4-7a00aee1530d2026-01-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202433
application number: ANDA202433
Tamsulosin HydrochlorideTAMSULOSIN HYDROCHLORIDERising Pharma Holdings, Inc.a242c8dc-576e-4a1f-a9e7-a05d7ebc0e0a2026-01-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202433
application number: ANDA202433
Tamsulosin HydrochlorideTAMSULOSIN HYDROCHLORIDENorthwind Health Company, LLCd9df4fe0-90ab-0d96-e053-2a95a90a5ff12026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202433
application number: ANDA202433
Tamsulosin HydrochlorideTAMSULOSIN HYDROCHLORIDECardinal Health 107, LLC0e3206ba-db3e-40b3-b46b-c7ae4703fdea2025-10-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202433
application number: ANDA202433
Tamsulosin HydrochlorideTAMSULOSIN HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.f6b6aeab-bedd-4254-8811-4f65cf8a351f2025-10-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202433
application number: ANDA202433
Tamsulosin HydrochlorideTAMSULOSIN HYDROCHLORIDEA-S Medication Solutions6a2a4cc7-c88a-4555-a247-d1e63206ffc52025-10-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202433
application number: ANDA202433
Tamsulosin HydrochlorideTAMSULOSIN HYDROCHLORIDEA-S Medication Solutions00bb2d71-1f21-494c-aa66-a82be3a0a8e62025-10-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202433
application number: ANDA202433
Tamsulosin HydrochlorideTAMSULOSIN HYDROCHLORIDEA-S Medication Solutions1d70b04e-ca08-48d3-937b-eb701b40dd8a2025-10-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202433
application number: ANDA202433
Tamsulosin HydrochlorideTAMSULOSIN HYDROCHLORIDEPreferred Pharmaceuticals, Inc.82d65964-de00-42c2-baaa-cc3de744b8eb2025-09-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202433
application number: ANDA202433
Tamsulosin HydrochlorideTAMSULOSIN HYDROCHLORIDEMajor Pharmaceuticalsf8302a6e-b8da-4931-a279-b49e379438162025-09-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202433
application number: ANDA202433
Tamsulosin HydrochlorideTAMSULOSIN HYDROCHLORIDEBryant Ranch Prepack36b8c36f-22e5-40f5-a99a-411115f13df42025-05-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202433
application number: ANDA202433
Tamsulosin HydrochlorideTAMSULOSIN HYDROCHLORIDENuCare Pharmaceuticals,Inc.cfd48327-a528-58cc-e053-2995a90a129f2025-02-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202433
application number: ANDA202433

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
863669tamsulosin HCl 0.4 MG Oral CapsulePSN503d080c-9db3-434a-add6-c7d0e5a0ab2e17
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCD503d080c-9db3-434a-add6-c7d0e5a0ab2e17
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSY503d080c-9db3-434a-add6-c7d0e5a0ab2e17

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0615-8055-050061580550515 CAPSULE in 1 BLISTER PACK (0615-8055-05) 15 capsule2013-04-300000-00-00NoNoCurrent
0615-8055-07006158055077 CAPSULE in 1 BLISTER PACK (0615-8055-07) 7 capsule2018-09-270000-00-00NoNoCurrent
0615-8055-140061580551414 CAPSULE in 1 BLISTER PACK (0615-8055-14) 14 capsule2023-08-24NoNoCurrent
0615-8055-280061580552828 CAPSULE in 1 BLISTER PACK (0615-8055-28) 28 capsule2024-04-25NoNoCurrent
0615-8055-30006158055306 BLISTER PACK in 1 BOX, UNIT-DOSE (0615-8055-30) / 5 CAPSULE in 1 BLISTER PACK6 blister pack2019-03-280000-00-00NoNoCurrent
0615-8055-390061580553930 CAPSULE in 1 BLISTER PACK (0615-8055-39) 30 capsule2013-04-300000-00-00NoNoCurrent