Tamsulosin Hydrochloride

Product NDC
68382-132
11-digit product format
683820132
Labeler code
68382
Product ID
68382-132_ee9d9efd-0c79-4993-bfd7-d4c30e20bddd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tamsulosin Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Zydus Pharmaceuticals USA Inc.
Application
ANDA078225
Marketing category
ANDA
Marketing start
2010-04-27
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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
ae349df8-97ce-a639-ed32-50a4cb01b1bdProduct name420200313

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68382-132-01Tamsulosin Hydrochloride100 in 1 BOTTLECAPSULE10015
68382-132-05Tamsulosin Hydrochloride500 in 1 BOTTLECAPSULE50015
68382-132-06Tamsulosin Hydrochloride30 in 1 BOTTLECAPSULE3015
68382-132-10Tamsulosin Hydrochloride1000 in 1 BOTTLECAPSULE100015
68382-132-14Tamsulosin Hydrochloride60 in 1 BOTTLECAPSULE6015
68382-132-16Tamsulosin Hydrochloride90 in 1 BOTTLECAPSULE9015
68382-132-30Tamsulosin Hydrochloride1 in 1 BLISTER PACKCAPSULE115
68382-132-77Tamsulosin Hydrochloride100 in 1 CARTONCAPSULE10015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68382-132-01EA - Each68382-132d0b15e38-77dd-4626-9415-e8ea838cd27a12012-07-24
68382-132-10EA - Each68382-132b0f4c6b5-aca7-4bc5-9fb6-251c3748b0a312012-07-24
68382-132-16EA - Each68382-132beae02d2-9ba0-4a43-9241-2eb11944bcf312025-05-14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TAMSULOSIN HYDROCHLORIDEACTIVE INGREDIENT11SV1951MRTAMSULOSIN HYDROCHLORIDE CAPSULE [ZYDUS PHARMACEUTICALS (USA) INC.]8
TAMSULOSINACTIVE MOIETYG3P28OML5ITAMSULOSIN HYDROCHLORIDE CAPSULE [ZYDUS PHARMACEUTICALS (USA) INC.]8
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTAMSULOSIN HYDROCHLORIDE CAPSULE [ZYDUS PHARMACEUTICALS (USA) INC.]8
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GTAMSULOSIN HYDROCHLORIDE CAPSULE [ZYDUS PHARMACEUTICALS (USA) INC.]8
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDTAMSULOSIN HYDROCHLORIDE CAPSULE [ZYDUS PHARMACEUTICALS (USA) INC.]8
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOATAMSULOSIN HYDROCHLORIDE CAPSULE [ZYDUS PHARMACEUTICALS (USA) INC.]8
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8TAMSULOSIN HYDROCHLORIDE CAPSULE [ZYDUS PHARMACEUTICALS (USA) INC.]8
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTTAMSULOSIN HYDROCHLORIDE CAPSULE [ZYDUS PHARMACEUTICALS (USA) INC.]8
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357TAMSULOSIN HYDROCHLORIDE CAPSULE [ZYDUS PHARMACEUTICALS (USA) INC.]8
GELATININACTIVE INGREDIENT2G86QN327LTAMSULOSIN HYDROCHLORIDE CAPSULE [ZYDUS PHARMACEUTICALS (USA) INC.]8
METHACRYLIC ACIDINACTIVE INGREDIENT1CS02G8656TAMSULOSIN HYDROCHLORIDE CAPSULE [ZYDUS PHARMACEUTICALS (USA) INC.]8
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HTAMSULOSIN HYDROCHLORIDE CAPSULE [ZYDUS PHARMACEUTICALS (USA) INC.]8
TALCINACTIVE INGREDIENT7SEV7J4R1UTAMSULOSIN HYDROCHLORIDE CAPSULE [ZYDUS PHARMACEUTICALS (USA) INC.]8
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTAMSULOSIN HYDROCHLORIDE CAPSULE [ZYDUS PHARMACEUTICALS (USA) INC.]8
TRIACETININACTIVE INGREDIENTXHX3C3X673TAMSULOSIN HYDROCHLORIDE CAPSULE [ZYDUS PHARMACEUTICALS (USA) INC.]8
TAMSULOSIN HYDROCHLORIDEACTIVE INGREDIENT11SV1951MRTAMSULOSIN HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]4
TAMSULOSINACTIVE MOIETYG3P28OML5ITAMSULOSIN HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTAMSULOSIN HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]4
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GTAMSULOSIN HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]4
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDTAMSULOSIN HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]4
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOATAMSULOSIN HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]4
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8TAMSULOSIN HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]4
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTTAMSULOSIN HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]4
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357TAMSULOSIN HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]4
GELATININACTIVE INGREDIENT2G86QN327LTAMSULOSIN HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]4
METHACRYLIC ACIDINACTIVE INGREDIENT1CS02G8656TAMSULOSIN HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]4
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HTAMSULOSIN HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]4
TALCINACTIVE INGREDIENT7SEV7J4R1UTAMSULOSIN HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTAMSULOSIN HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]4
TRIACETININACTIVE INGREDIENTXHX3C3X673TAMSULOSIN HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]4
TAMSULOSIN HYDROCHLORIDEACTIVE INGREDIENT11SV1951MRTAMSULOSIN HYDROCHLORIDE CAPSULE [AMERICAN HEALTH PACKAGING]3
TAMSULOSINACTIVE MOIETYG3P28OML5ITAMSULOSIN HYDROCHLORIDE CAPSULE [AMERICAN HEALTH PACKAGING]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTAMSULOSIN HYDROCHLORIDE CAPSULE [AMERICAN HEALTH PACKAGING]3
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GTAMSULOSIN HYDROCHLORIDE CAPSULE [AMERICAN HEALTH PACKAGING]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDTAMSULOSIN HYDROCHLORIDE CAPSULE [AMERICAN HEALTH PACKAGING]3
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOATAMSULOSIN HYDROCHLORIDE CAPSULE [AMERICAN HEALTH PACKAGING]3
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8TAMSULOSIN HYDROCHLORIDE CAPSULE [AMERICAN HEALTH PACKAGING]3
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTTAMSULOSIN HYDROCHLORIDE CAPSULE [AMERICAN HEALTH PACKAGING]3
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357TAMSULOSIN HYDROCHLORIDE CAPSULE [AMERICAN HEALTH PACKAGING]3
GELATININACTIVE INGREDIENT2G86QN327LTAMSULOSIN HYDROCHLORIDE CAPSULE [AMERICAN HEALTH PACKAGING]3
METHACRYLIC ACIDINACTIVE INGREDIENT1CS02G8656TAMSULOSIN HYDROCHLORIDE CAPSULE [AMERICAN HEALTH PACKAGING]3
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HTAMSULOSIN HYDROCHLORIDE CAPSULE [AMERICAN HEALTH PACKAGING]3
TALCINACTIVE INGREDIENT7SEV7J4R1UTAMSULOSIN HYDROCHLORIDE CAPSULE [AMERICAN HEALTH PACKAGING]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTAMSULOSIN HYDROCHLORIDE CAPSULE [AMERICAN HEALTH PACKAGING]3
TRIACETININACTIVE INGREDIENTXHX3C3X673TAMSULOSIN HYDROCHLORIDE CAPSULE [AMERICAN HEALTH PACKAGING]3
TAMSULOSIN HYDROCHLORIDEACTIVE INGREDIENT11SV1951MRTAMSULOSIN HYDROCHLORIDE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
TAMSULOSIN HYDROCHLORIDEACTIVE INGREDIENT11SV1951MRTAMSULOSIN HYDROCHLORIDE CAPSULE [CONTRACT PHARMACY SERVICES-PA]1
TAMSULOSINACTIVE MOIETYG3P28OML5ITAMSULOSIN HYDROCHLORIDE CAPSULE [CONTRACT PHARMACY SERVICES-PA]1
TAMSULOSINACTIVE MOIETYG3P28OML5ITAMSULOSIN HYDROCHLORIDE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTAMSULOSIN HYDROCHLORIDE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTAMSULOSIN HYDROCHLORIDE CAPSULE [CONTRACT PHARMACY SERVICES-PA]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GTAMSULOSIN HYDROCHLORIDE CAPSULE [CONTRACT PHARMACY SERVICES-PA]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GTAMSULOSIN HYDROCHLORIDE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDTAMSULOSIN HYDROCHLORIDE CAPSULE [CONTRACT PHARMACY SERVICES-PA]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDTAMSULOSIN HYDROCHLORIDE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOATAMSULOSIN HYDROCHLORIDE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOATAMSULOSIN HYDROCHLORIDE CAPSULE [CONTRACT PHARMACY SERVICES-PA]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8TAMSULOSIN HYDROCHLORIDE CAPSULE [CONTRACT PHARMACY SERVICES-PA]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8TAMSULOSIN HYDROCHLORIDE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTTAMSULOSIN HYDROCHLORIDE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTTAMSULOSIN HYDROCHLORIDE CAPSULE [CONTRACT PHARMACY SERVICES-PA]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357TAMSULOSIN HYDROCHLORIDE CAPSULE [CONTRACT PHARMACY SERVICES-PA]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357TAMSULOSIN HYDROCHLORIDE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
GELATININACTIVE INGREDIENT2G86QN327LTAMSULOSIN HYDROCHLORIDE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
GELATININACTIVE INGREDIENT2G86QN327LTAMSULOSIN HYDROCHLORIDE CAPSULE [CONTRACT PHARMACY SERVICES-PA]1
METHACRYLIC ACIDINACTIVE INGREDIENT1CS02G8656TAMSULOSIN HYDROCHLORIDE CAPSULE [CONTRACT PHARMACY SERVICES-PA]1
METHACRYLIC ACIDINACTIVE INGREDIENT1CS02G8656TAMSULOSIN HYDROCHLORIDE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HTAMSULOSIN HYDROCHLORIDE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HTAMSULOSIN HYDROCHLORIDE CAPSULE [CONTRACT PHARMACY SERVICES-PA]1
TALCINACTIVE INGREDIENT7SEV7J4R1UTAMSULOSIN HYDROCHLORIDE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
TALCINACTIVE INGREDIENT7SEV7J4R1UTAMSULOSIN HYDROCHLORIDE CAPSULE [CONTRACT PHARMACY SERVICES-PA]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTAMSULOSIN HYDROCHLORIDE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTAMSULOSIN HYDROCHLORIDE CAPSULE [CONTRACT PHARMACY SERVICES-PA]1
TRIACETININACTIVE INGREDIENTXHX3C3X673TAMSULOSIN HYDROCHLORIDE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
TRIACETININACTIVE INGREDIENTXHX3C3X673TAMSULOSIN HYDROCHLORIDE CAPSULE [CONTRACT PHARMACY SERVICES-PA]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68382-132TAMSULOSIN HYDROCHLORIDE CAPSULE [ZYDUS PHARMACEUTICALS USA INC.]15Current NDC, Legacy NDC, 8 package rows20231110_300be29a-c56d-4daa-ba89-f207c281ea20.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
863669tamsulosin HCl 0.4 MG Oral CapsulePSN300be29a-c56d-4daa-ba89-f207c281ea2015
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCD300be29a-c56d-4daa-ba89-f207c281ea2015
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSY300be29a-c56d-4daa-ba89-f207c281ea2015
863669tamsulosin HCl 0.4 MG Oral CapsulePSN8150a710-aee5-4841-ae1b-7d2e61281a8f12
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCD8150a710-aee5-4841-ae1b-7d2e61281a8f12
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSY8150a710-aee5-4841-ae1b-7d2e61281a8f12
863669tamsulosin HCl 0.4 MG Oral CapsulePSNe9372720-bd02-e4a6-0afd-42fe0c661c0011
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCDe9372720-bd02-e4a6-0afd-42fe0c661c0011
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSYe9372720-bd02-e4a6-0afd-42fe0c661c0011
863669tamsulosin HCl 0.4 MG Oral CapsulePSN1cfc75bd-69bb-e6c2-e063-6394a90ab60e1
863669tamsulosin HCl 0.4 MG Oral CapsulePSN4ef1a932-b5b2-4ea7-a625-388dd78f90581
863669tamsulosin HCl 0.4 MG Oral CapsulePSNc963384e-eb50-4462-9aea-ed9d26d267d61
863669tamsulosin HCl 0.4 MG Oral CapsulePSN52bbe73b-43b6-3393-e063-6294a90a6dc61
863669tamsulosin HCl 0.4 MG Oral CapsulePSN7350ad6e-7745-4743-9aa4-2a14ff01fef41
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCDc963384e-eb50-4462-9aea-ed9d26d267d61
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCD7350ad6e-7745-4743-9aa4-2a14ff01fef41
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCD1cfc75bd-69bb-e6c2-e063-6394a90ab60e1
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCD52bbe73b-43b6-3393-e063-6294a90a6dc61
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCD4ef1a932-b5b2-4ea7-a625-388dd78f90581
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSY7350ad6e-7745-4743-9aa4-2a14ff01fef41
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSYc963384e-eb50-4462-9aea-ed9d26d267d61
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSY52bbe73b-43b6-3393-e063-6294a90a6dc61
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSY4ef1a932-b5b2-4ea7-a625-388dd78f90581
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSY1cfc75bd-69bb-e6c2-e063-6394a90ab60e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68382-132-0168382013201100 CAPSULE in 1 BOTTLE (68382-132-01) 100 capsule2010-04-270000-00-00NoNoCurrent
68382-132-0568382013205500 CAPSULE in 1 BOTTLE (68382-132-05) 500 capsule2010-04-270000-00-00NoNoCurrent
68382-132-066838201320630 CAPSULE in 1 BOTTLE (68382-132-06) 30 capsule2010-04-270000-00-00NoNoCurrent
68382-132-10683820132101000 CAPSULE in 1 BOTTLE (68382-132-10) 1000 capsule2010-04-270000-00-00NoNoCurrent
68382-132-146838201321460 CAPSULE in 1 BOTTLE (68382-132-14) 60 capsule2010-04-270000-00-00NoNoCurrent
68382-132-166838201321690 CAPSULE in 1 BOTTLE (68382-132-16) 90 capsule2010-04-270000-00-00NoNoCurrent
68382-132-30683820132301 in 1 BLISTER PACKHistorical
68382-132-7768382013277100 BLISTER PACK in 1 CARTON (68382-132-77) / 1 CAPSULE in 1 BLISTER PACK (68382-132-30) 100 blister pack2010-04-270000-00-00NoNoCurrent