FDA.reportPublic FDA data

Tamsulosin Hydrochloride

Product NDC
65862-598
11-digit product format
658620598
Labeler code
65862
Product ID
65862-598_94771a21-3051-46cc-8deb-200bc9f3dcb3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tamsulosin Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Aurobindo Pharma Limited
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

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 Identifiers#

Field, Values table
FieldValues
Unii11SV1951MR
Rxcui863669

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ee39297f-c54b-4394-13fa-e0de7b5b9070Product name420250305
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
ae349df8-97ce-a639-ed32-50a4cb01b1bdProduct name420200313
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65862-598-01Tamsulosin Hydrochloride100 in 1 BOTTLECAPSULE10016
65862-598-05Tamsulosin Hydrochloride500 in 1 BOTTLECAPSULE50016
65862-598-10Tamsulosin Hydrochloride10 in 1 BLISTER PACKCAPSULE1016
65862-598-10Tamsulosin Hydrochloride3 in 1 CARTONCAPSULE316

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TAMSULOSIN HYDROCHLORIDEACTIVE INGREDIENT11SV1951MRTAMSULOSIN HYDROCHLORIDE CAPSULE [AUROBINDO PHARMA LIMITED]4
TAMSULOSINACTIVE MOIETYG3P28OML5ITAMSULOSIN HYDROCHLORIDE CAPSULE [AUROBINDO PHARMA LIMITED]4
ALCOHOLINACTIVE INGREDIENT3K9958V90MTAMSULOSIN HYDROCHLORIDE CAPSULE [AUROBINDO PHARMA LIMITED]4
AMMONIAINACTIVE INGREDIENT5138Q19F1XTAMSULOSIN HYDROCHLORIDE CAPSULE [AUROBINDO PHARMA LIMITED]4
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3TAMSULOSIN HYDROCHLORIDE CAPSULE [AUROBINDO PHARMA LIMITED]4
CALCIUM STEARATEINACTIVE INGREDIENT776XM7047LTAMSULOSIN HYDROCHLORIDE CAPSULE [AUROBINDO PHARMA LIMITED]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTAMSULOSIN HYDROCHLORIDE CAPSULE [AUROBINDO PHARMA LIMITED]4
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKTAMSULOSIN HYDROCHLORIDE CAPSULE [AUROBINDO PHARMA LIMITED]4
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675TAMSULOSIN HYDROCHLORIDE CAPSULE [AUROBINDO PHARMA LIMITED]4
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTTAMSULOSIN HYDROCHLORIDE CAPSULE [AUROBINDO PHARMA LIMITED]4
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357TAMSULOSIN HYDROCHLORIDE CAPSULE [AUROBINDO PHARMA LIMITED]4
GELATININACTIVE INGREDIENT2G86QN327LTAMSULOSIN HYDROCHLORIDE CAPSULE [AUROBINDO PHARMA LIMITED]4
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302TAMSULOSIN HYDROCHLORIDE CAPSULE [AUROBINDO PHARMA LIMITED]4
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JTAMSULOSIN HYDROCHLORIDE CAPSULE [AUROBINDO PHARMA LIMITED]4
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TTAMSULOSIN HYDROCHLORIDE CAPSULE [AUROBINDO PHARMA LIMITED]4
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3TAMSULOSIN HYDROCHLORIDE CAPSULE [AUROBINDO PHARMA LIMITED]4
SHELLACINACTIVE INGREDIENT46N107B71OTAMSULOSIN HYDROCHLORIDE CAPSULE [AUROBINDO PHARMA LIMITED]4
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JTAMSULOSIN HYDROCHLORIDE CAPSULE [AUROBINDO PHARMA LIMITED]4
TALCINACTIVE INGREDIENT7SEV7J4R1UTAMSULOSIN HYDROCHLORIDE CAPSULE [AUROBINDO PHARMA LIMITED]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTAMSULOSIN HYDROCHLORIDE CAPSULE [AUROBINDO PHARMA LIMITED]4
TRIACETININACTIVE INGREDIENTXHX3C3X673TAMSULOSIN HYDROCHLORIDE CAPSULE [AUROBINDO PHARMA LIMITED]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-598TAMSULOSIN HYDROCHLORIDE CAPSULE [AUROBINDO PHARMA LIMITED]16Current NDC, Legacy NDC, 4 package rows20231118_8cb27f78-2d5d-4640-b7b5-ed06973c8133.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
863669tamsulosin HCl 0.4 MG Oral CapsulePSN36b8c36f-22e5-40f5-a99a-411115f13df4100
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCD36b8c36f-22e5-40f5-a99a-411115f13df4100
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSY36b8c36f-22e5-40f5-a99a-411115f13df4100
863669tamsulosin HCl 0.4 MG Oral CapsulePSNf6b6aeab-bedd-4254-8811-4f65cf8a351f22
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCDf6b6aeab-bedd-4254-8811-4f65cf8a351f22
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSYf6b6aeab-bedd-4254-8811-4f65cf8a351f22
863669tamsulosin HCl 0.4 MG Oral CapsulePSNa608ddc8-fe42-484e-b61f-307c6015113817
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCDa608ddc8-fe42-484e-b61f-307c6015113817
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSYa608ddc8-fe42-484e-b61f-307c6015113817
863669tamsulosin HCl 0.4 MG Oral CapsulePSN8cb27f78-2d5d-4640-b7b5-ed06973c813316
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCD8cb27f78-2d5d-4640-b7b5-ed06973c813316
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSY8cb27f78-2d5d-4640-b7b5-ed06973c813316
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
863669tamsulosin HCl 0.4 MG Oral CapsulePSN58bdac81-680a-4fd2-8f05-dd5b865535698
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCD58bdac81-680a-4fd2-8f05-dd5b865535698
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSY58bdac81-680a-4fd2-8f05-dd5b865535698
863669tamsulosin HCl 0.4 MG Oral CapsulePSN6cb939a6-2bc6-5ca0-e053-2991aa0a4e697
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCD6cb939a6-2bc6-5ca0-e053-2991aa0a4e697
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSY6cb939a6-2bc6-5ca0-e053-2991aa0a4e697
863669tamsulosin HCl 0.4 MG Oral CapsulePSN82d65964-de00-42c2-baaa-cc3de744b8eb6
863669tamsulosin HCl 0.4 MG Oral CapsulePSN1d70b04e-ca08-48d3-937b-eb701b40dd8a6
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCD1d70b04e-ca08-48d3-937b-eb701b40dd8a6
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCD82d65964-de00-42c2-baaa-cc3de744b8eb6
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSY1d70b04e-ca08-48d3-937b-eb701b40dd8a6
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSY82d65964-de00-42c2-baaa-cc3de744b8eb6
863669tamsulosin HCl 0.4 MG Oral CapsulePSN4fe6f814-a878-1247-e054-00144ff8d46c5
863669tamsulosin HCl 0.4 MG Oral CapsulePSN6142d7b6-e5ea-1af0-e053-2991aa0a00cd5
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCD4fe6f814-a878-1247-e054-00144ff8d46c5
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCD6142d7b6-e5ea-1af0-e053-2991aa0a00cd5
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSY4fe6f814-a878-1247-e054-00144ff8d46c5
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSY6142d7b6-e5ea-1af0-e053-2991aa0a00cd5
863669tamsulosin HCl 0.4 MG Oral CapsulePSN8de50eca-8cc5-082d-e053-2a95a90a346d4
863669tamsulosin HCl 0.4 MG Oral CapsulePSN25d5ceab-a04b-4cf0-bc48-3d0c6d8af0064
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCD25d5ceab-a04b-4cf0-bc48-3d0c6d8af0064
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCD8de50eca-8cc5-082d-e053-2a95a90a346d4
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSY25d5ceab-a04b-4cf0-bc48-3d0c6d8af0064
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSY8de50eca-8cc5-082d-e053-2a95a90a346d4
863669tamsulosin HCl 0.4 MG Oral CapsulePSN985871d9-81e2-5fda-e053-2995a90a03383
863669tamsulosin HCl 0.4 MG Oral CapsulePSNd9df4fe0-90ab-0d96-e053-2a95a90a5ff13
863669tamsulosin HCl 0.4 MG Oral CapsulePSNf8302a6e-b8da-4931-a279-b49e379438163
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCD985871d9-81e2-5fda-e053-2995a90a03383
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCDf8302a6e-b8da-4931-a279-b49e379438163
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCDd9df4fe0-90ab-0d96-e053-2a95a90a5ff13
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSYf8302a6e-b8da-4931-a279-b49e379438163
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSY985871d9-81e2-5fda-e053-2995a90a03383
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSYd9df4fe0-90ab-0d96-e053-2a95a90a5ff13
863669tamsulosin HCl 0.4 MG Oral CapsulePSNf0ac7598-8e98-47e3-a9f7-ee393d807ca22
863669tamsulosin HCl 0.4 MG Oral CapsulePSN01f390a6-bb2c-4293-9d3d-76b6bec094c22
863669tamsulosin HCl 0.4 MG Oral CapsulePSNe0ad49c7-f57c-45c6-9084-16d8b79c8f872
863669tamsulosin HCl 0.4 MG Oral CapsulePSN14c1fc86-76bd-499d-871a-e6830bea23222
863669tamsulosin HCl 0.4 MG Oral CapsulePSN7a420aca-31e6-8e0c-e053-2a91aa0a1be02
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCD14c1fc86-76bd-499d-871a-e6830bea23222
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCD01f390a6-bb2c-4293-9d3d-76b6bec094c22
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCD7a420aca-31e6-8e0c-e053-2a91aa0a1be02
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCDe0ad49c7-f57c-45c6-9084-16d8b79c8f872
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCDf0ac7598-8e98-47e3-a9f7-ee393d807ca22
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSY01f390a6-bb2c-4293-9d3d-76b6bec094c22
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSYe0ad49c7-f57c-45c6-9084-16d8b79c8f872
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSY14c1fc86-76bd-499d-871a-e6830bea23222
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSYf0ac7598-8e98-47e3-a9f7-ee393d807ca22
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSY7a420aca-31e6-8e0c-e053-2a91aa0a1be02
863669tamsulosin HCl 0.4 MG Oral CapsulePSN2642c5e1-47c1-b87b-e063-6294a90af6ce1
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCD2642c5e1-47c1-b87b-e063-6294a90af6ce1
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSY2642c5e1-47c1-b87b-e063-6294a90af6ce1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65862-598-0165862059801100 CAPSULE in 1 BOTTLE (65862-598-01) 100 capsule2013-04-300000-00-00NoNoCurrent
65862-598-0565862059805500 CAPSULE in 1 BOTTLE (65862-598-05) 500 capsule2013-04-300000-00-00NoNoCurrent
65862-598-10658620598103 BLISTER PACK in 1 CARTON (65862-598-10) / 10 CAPSULE in 1 BLISTER PACK3 blister pack2013-04-300000-00-00NoNoCurrent
65862-598-22658620598222000 CAPSULE in 1 BAG (65862-598-22)2000 capsule30-APR-13Current