FDA.reportPublic FDA data

Tamsulosin Hydrochloride

Product NDC
57237-014
11-digit product format
572370014
Labeler code
57237
Product ID
57237-014_f89b21ae-6df5-4250-8034-92dd3b074ab9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tamsulosin Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Rising Pharma Holdings, Inc.
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Tamsulosin Hydrochloride
Listing expiration
2027-12-31

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
ae349df8-97ce-a639-ed32-50a4cb01b1bdProduct name420200313

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57237-014-01Tamsulosin Hydrochloride100 in 1 BOTTLECAPSULE10013
57237-014-05Tamsulosin Hydrochloride500 in 1 BOTTLECAPSULE50013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57237-014-01EA - Each57237-0146d2e3fff-969a-4b9e-a7bb-8bea607e0f9212014-11-05
57237-014-05EA - Each57237-0149db5e116-e5cb-4662-98e8-6a07202961ee12014-11-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TAMSULOSIN HYDROCHLORIDEACTIVE INGREDIENT11SV1951MRTAMSULOSIN HYDROCHLORIDE CAPSULE [CITRON PHARMA LLC]3
TAMSULOSINACTIVE MOIETYG3P28OML5ITAMSULOSIN HYDROCHLORIDE CAPSULE [CITRON PHARMA LLC]3
ALCOHOLINACTIVE INGREDIENT3K9958V90MTAMSULOSIN HYDROCHLORIDE CAPSULE [CITRON PHARMA LLC]3
AMMONIAINACTIVE INGREDIENT5138Q19F1XTAMSULOSIN HYDROCHLORIDE CAPSULE [CITRON PHARMA LLC]3
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3TAMSULOSIN HYDROCHLORIDE CAPSULE [CITRON PHARMA LLC]3
CALCIUM STEARATEINACTIVE INGREDIENT776XM7047LTAMSULOSIN HYDROCHLORIDE CAPSULE [CITRON PHARMA LLC]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTAMSULOSIN HYDROCHLORIDE CAPSULE [CITRON PHARMA LLC]3
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKTAMSULOSIN HYDROCHLORIDE CAPSULE [CITRON PHARMA LLC]3
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675TAMSULOSIN HYDROCHLORIDE CAPSULE [CITRON PHARMA LLC]3
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTTAMSULOSIN HYDROCHLORIDE CAPSULE [CITRON PHARMA LLC]3
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357TAMSULOSIN HYDROCHLORIDE CAPSULE [CITRON PHARMA LLC]3
GELATININACTIVE INGREDIENT2G86QN327LTAMSULOSIN HYDROCHLORIDE CAPSULE [CITRON PHARMA LLC]3
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302TAMSULOSIN HYDROCHLORIDE CAPSULE [CITRON PHARMA LLC]3
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JTAMSULOSIN HYDROCHLORIDE CAPSULE [CITRON PHARMA LLC]3
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TTAMSULOSIN HYDROCHLORIDE CAPSULE [CITRON PHARMA LLC]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3TAMSULOSIN HYDROCHLORIDE CAPSULE [CITRON PHARMA LLC]3
SHELLACINACTIVE INGREDIENT46N107B71OTAMSULOSIN HYDROCHLORIDE CAPSULE [CITRON PHARMA LLC]3
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JTAMSULOSIN HYDROCHLORIDE CAPSULE [CITRON PHARMA LLC]3
TALCINACTIVE INGREDIENT7SEV7J4R1UTAMSULOSIN HYDROCHLORIDE CAPSULE [CITRON PHARMA LLC]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTAMSULOSIN HYDROCHLORIDE CAPSULE [CITRON PHARMA LLC]3
TRIACETININACTIVE INGREDIENTXHX3C3X673TAMSULOSIN HYDROCHLORIDE CAPSULE [CITRON PHARMA LLC]3
TAMSULOSIN HYDROCHLORIDEACTIVE INGREDIENT11SV1951MRTAMSULOSIN HYDROCHLORIDE CAPSULE [DIRECTRX]1
TAMSULOSINACTIVE MOIETYG3P28OML5ITAMSULOSIN HYDROCHLORIDE CAPSULE [DIRECTRX]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MTAMSULOSIN HYDROCHLORIDE CAPSULE [DIRECTRX]1
AMMONIAINACTIVE INGREDIENT5138Q19F1XTAMSULOSIN HYDROCHLORIDE CAPSULE [DIRECTRX]1
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3TAMSULOSIN HYDROCHLORIDE CAPSULE [DIRECTRX]1
CALCIUM STEARATEINACTIVE INGREDIENT776XM7047LTAMSULOSIN HYDROCHLORIDE CAPSULE [DIRECTRX]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTAMSULOSIN HYDROCHLORIDE CAPSULE [DIRECTRX]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKTAMSULOSIN HYDROCHLORIDE CAPSULE [DIRECTRX]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675TAMSULOSIN HYDROCHLORIDE CAPSULE [DIRECTRX]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTTAMSULOSIN HYDROCHLORIDE CAPSULE [DIRECTRX]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357TAMSULOSIN HYDROCHLORIDE CAPSULE [DIRECTRX]1
GELATININACTIVE INGREDIENT2G86QN327LTAMSULOSIN HYDROCHLORIDE CAPSULE [DIRECTRX]1
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302TAMSULOSIN HYDROCHLORIDE CAPSULE [DIRECTRX]1
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JTAMSULOSIN HYDROCHLORIDE CAPSULE [DIRECTRX]1
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TTAMSULOSIN HYDROCHLORIDE CAPSULE [DIRECTRX]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3TAMSULOSIN HYDROCHLORIDE CAPSULE [DIRECTRX]1
SHELLACINACTIVE INGREDIENT46N107B71OTAMSULOSIN HYDROCHLORIDE CAPSULE [DIRECTRX]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JTAMSULOSIN HYDROCHLORIDE CAPSULE [DIRECTRX]1
TALCINACTIVE INGREDIENT7SEV7J4R1UTAMSULOSIN HYDROCHLORIDE CAPSULE [DIRECTRX]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTAMSULOSIN HYDROCHLORIDE CAPSULE [DIRECTRX]1
TRIACETININACTIVE INGREDIENTXHX3C3X673TAMSULOSIN HYDROCHLORIDE CAPSULE [DIRECTRX]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57237-014TAMSULOSIN HYDROCHLORIDE CAPSULE [RISING PHARMA HOLDINGS, INC.]12Current NDC, Legacy NDC, 2 package rows20231123_a242c8dc-576e-4a1f-a9e7-a05d7ebc0e0a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
863669tamsulosin HCl 0.4 MG Oral CapsulePSN59d0e07c-0018-4681-beb2-cb1c8e2637ee103
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCD59d0e07c-0018-4681-beb2-cb1c8e2637ee103
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSY59d0e07c-0018-4681-beb2-cb1c8e2637ee103
863669tamsulosin HCl 0.4 MG Oral CapsulePSNfd73ddfd-3773-45b2-9795-9e58744a6803101
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCDfd73ddfd-3773-45b2-9795-9e58744a6803101
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSYfd73ddfd-3773-45b2-9795-9e58744a6803101
863669tamsulosin HCl 0.4 MG Oral CapsulePSNf543f5d1-3348-4066-99a4-7a00aee1530d19
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCDf543f5d1-3348-4066-99a4-7a00aee1530d19
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSYf543f5d1-3348-4066-99a4-7a00aee1530d19
863669tamsulosin HCl 0.4 MG Oral CapsulePSNb30e2bde-b20e-4899-a100-f44170d8165b18
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCDb30e2bde-b20e-4899-a100-f44170d8165b18
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSYb30e2bde-b20e-4899-a100-f44170d8165b18
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
863669tamsulosin HCl 0.4 MG Oral CapsulePSNa242c8dc-576e-4a1f-a9e7-a05d7ebc0e0a13
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCDa242c8dc-576e-4a1f-a9e7-a05d7ebc0e0a13
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSYa242c8dc-576e-4a1f-a9e7-a05d7ebc0e0a13
863669tamsulosin HCl 0.4 MG Oral CapsulePSN7275902e-6832-4e71-997a-d1f7fc1c6a115
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCD7275902e-6832-4e71-997a-d1f7fc1c6a115
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSY7275902e-6832-4e71-997a-d1f7fc1c6a115
863669tamsulosin HCl 0.4 MG Oral CapsulePSN4eb7d5cc-b12f-67e2-e054-00144ff8d46c4
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCD4eb7d5cc-b12f-67e2-e054-00144ff8d46c4
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSY4eb7d5cc-b12f-67e2-e054-00144ff8d46c4
863669tamsulosin HCl 0.4 MG Oral CapsulePSNcfd48327-a528-58cc-e053-2995a90a129f3
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCDcfd48327-a528-58cc-e053-2995a90a129f3
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSYcfd48327-a528-58cc-e053-2995a90a129f3
863669tamsulosin HCl 0.4 MG Oral CapsulePSN255eab95-a7aa-3a37-e054-00144ff8d46c2
863669tamsulosin HCl 0.4 MG Oral CapsulePSN59a17ad9-3967-16b0-e053-2991aa0a9a402
863669tamsulosin HCl 0.4 MG Oral CapsulePSN4fbf72e0-c7e7-0a50-e054-00144ff8d46c2
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCD59a17ad9-3967-16b0-e053-2991aa0a9a402
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCD4fbf72e0-c7e7-0a50-e054-00144ff8d46c2
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCD255eab95-a7aa-3a37-e054-00144ff8d46c2
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSY59a17ad9-3967-16b0-e053-2991aa0a9a402
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSY4fbf72e0-c7e7-0a50-e054-00144ff8d46c2
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSY255eab95-a7aa-3a37-e054-00144ff8d46c2
863669tamsulosin HCl 0.4 MG Oral CapsulePSN3d06b06c-e28f-44ea-914c-6c9393e32f581
863669tamsulosin HCl 0.4 MG Oral CapsulePSN58cba3d8-bb57-4e64-a191-dc050904c8961
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCD3d06b06c-e28f-44ea-914c-6c9393e32f581
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCD58cba3d8-bb57-4e64-a191-dc050904c8961
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSY3d06b06c-e28f-44ea-914c-6c9393e32f581
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSY58cba3d8-bb57-4e64-a191-dc050904c8961

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57237-014-0157237001401100 CAPSULE in 1 BOTTLE (57237-014-01) 100 capsule2013-04-300000-00-00NoNoCurrent
57237-014-0557237001405500 CAPSULE in 1 BOTTLE (57237-014-05) 500 capsule2013-04-300000-00-00NoNoCurrent