Tamsulosin Hydrochloride

Product NDC
68084-299
11-digit product format
680840299
Labeler code
68084
Product ID
68084-299_38cbc0fa-ca6b-0e39-e063-6394a90abb97
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tamsulosin Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
American Health Packaging
Application
ANDA078225
Marketing category
ANDA
Marketing start
2014-01-17
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
ae349df8-97ce-a639-ed32-50a4cb01b1bdProduct name420200313

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68084-299-01Tamsulosin Hydrochloride100 in 1 BOX, UNIT-DOSECAPSULE10012
68084-299-11Tamsulosin Hydrochloride1 in 1 BLISTER PACKCAPSULE112
68084-299-65Tamsulosin Hydrochloride50 in 1 CARTONCAPSULE5012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68084-299-01EA - Each68084-299f1555159-662a-4418-837f-36830648cd7612014-04-03
68084-299-11EA - Each68084-299571bb59e-6a4f-4274-8176-f7bad17498e612014-04-03
68084-299-65EA - Each68084-299edca93bd-5f18-40ea-acb0-a7ffd551dd5f12025-08-11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68084-299TAMSULOSIN HYDROCHLORIDE CAPSULE [AMERICAN HEALTH PACKAGING]11Current NDC, Legacy NDC, 3 package rows20250424_8150a710-aee5-4841-ae1b-7d2e61281a8f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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 CapsulePSN5ed219aa-cf65-457f-8570-d26b48edb2403
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCD5ed219aa-cf65-457f-8570-d26b48edb2403
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSY5ed219aa-cf65-457f-8570-d26b48edb2403

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68084-299-0168084029901100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-299-01) / 1 CAPSULE in 1 BLISTER PACK (68084-299-11) 100 blister pack2014-01-170000-00-00NoNoCurrent
68084-299-11680840299111 in 1 BLISTER PACKHistorical
68084-299-656808402996550 BLISTER PACK in 1 CARTON (68084-299-65) / 1 CAPSULE in 1 BLISTER PACK (68084-299-11) 50 blister pack2025-07-01NoNoHistorical