Tamsulosin Hydrochloride

Product NDC
50090-1846
11-digit product format
500901846
Labeler code
50090
Product ID
50090-1846_bf8dacdc-a917-4c00-b1d1-2ce2c02f73c3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tamsulosin Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
A-S Medication Solutions
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
9631351f-66f4-45e5-a866-1e59311bd4d7Available 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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-1846-0Tamsulosin Hydrochloride30 in 1 BOTTLECAPSULE3013
50090-1846-1Tamsulosin Hydrochloride90 in 1 BOTTLECAPSULE9013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-1846-0EA - Each50090-1846c2ecc372-446b-40a7-a0c3-35c278f30bdf12018-11-06
50090-1846-1EA - Each50090-18463b76b584-afb8-4f9d-9af4-68fbdbda2ecb12018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-1846TAMSULOSIN HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS]13Current NDC, Legacy NDC, 2 package rows20240201_9631351f-66f4-45e5-a866-1e59311bd4d7.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 CapsulePSN9631351f-66f4-45e5-a866-1e59311bd4d713
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCD9631351f-66f4-45e5-a866-1e59311bd4d713
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSY9631351f-66f4-45e5-a866-1e59311bd4d713

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-1846-05009018460030 CAPSULE in 1 BOTTLE (50090-1846-0) 30 capsule2015-05-260000-00-00NoNoCurrent
50090-1846-15009018460190 CAPSULE in 1 BOTTLE (50090-1846-1) 90 capsule2015-05-260000-00-00NoNoCurrent