tamsulosin hydrochloride

Product NDC
0781-2076
11-digit product format
007812076
Labeler code
0781
Product ID
0781-2076_98c2abd9-1998-48cd-83f9-f5f94ff39345
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tamsulosin hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Sandoz Inc
Application
ANDA078015
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
ae349df8-97ce-a639-ed32-50a4cb01b1bdProduct name420200313

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0781-2076-01tamsulosin hydrochloride100 in 1 BOTTLECAPSULE10010
0781-2076-10tamsulosin hydrochloride1000 in 1 BOTTLECAPSULE100010
0781-2076-92tamsulosin hydrochloride90 in 1 BOTTLECAPSULE9010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0781-2076-01EA - Each0781-20769872e83c-cc49-494f-8cd2-97975764b34e12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TAMSULOSIN HYDROCHLORIDEACTIVE INGREDIENT11SV1951MRTAMSULOSIN HYDROCHLORIDE CAPSULE [SANDOZ INC]6
TAMSULOSINACTIVE MOIETYG3P28OML5ITAMSULOSIN HYDROCHLORIDE CAPSULE [SANDOZ INC]6
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTAMSULOSIN HYDROCHLORIDE CAPSULE [SANDOZ INC]6
ETHYL ACRYLATE AND METHYL METHACRYLATE COPOLYMER (2:1; 750000 MW)INACTIVE INGREDIENTP2OM2Q86BITAMSULOSIN HYDROCHLORIDE CAPSULE [SANDOZ INC]6
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKTAMSULOSIN HYDROCHLORIDE CAPSULE [SANDOZ INC]6
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675TAMSULOSIN HYDROCHLORIDE CAPSULE [SANDOZ INC]6
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTTAMSULOSIN HYDROCHLORIDE CAPSULE [SANDOZ INC]6
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357TAMSULOSIN HYDROCHLORIDE CAPSULE [SANDOZ INC]6
GELATININACTIVE INGREDIENT2G86QN327LTAMSULOSIN HYDROCHLORIDE CAPSULE [SANDOZ INC]6
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JTAMSULOSIN HYDROCHLORIDE CAPSULE [SANDOZ INC]6
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HTAMSULOSIN HYDROCHLORIDE CAPSULE [SANDOZ INC]6
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3TAMSULOSIN HYDROCHLORIDE CAPSULE [SANDOZ INC]6
SHELLACINACTIVE INGREDIENT46N107B71OTAMSULOSIN HYDROCHLORIDE CAPSULE [SANDOZ INC]6
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4TAMSULOSIN HYDROCHLORIDE CAPSULE [SANDOZ INC]6
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JTAMSULOSIN HYDROCHLORIDE CAPSULE [SANDOZ INC]6
TALCINACTIVE INGREDIENT7SEV7J4R1UTAMSULOSIN HYDROCHLORIDE CAPSULE [SANDOZ INC]6
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTAMSULOSIN HYDROCHLORIDE CAPSULE [SANDOZ INC]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0781-2076TAMSULOSIN HYDROCHLORIDE CAPSULE [SANDOZ INC]9Current NDC, Legacy NDC, 3 package rows20201124_fb120098-b007-4a33-80b8-b7279c7668ee.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
863669tamsulosin HCl 0.4 MG Oral CapsulePSNfb120098-b007-4a33-80b8-b7279c7668ee10
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCDfb120098-b007-4a33-80b8-b7279c7668ee10
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSYfb120098-b007-4a33-80b8-b7279c7668ee10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0781-2076-0100781207601100 CAPSULE in 1 BOTTLE (0781-2076-01) 100 capsule2010-04-270000-00-00NoNoCurrent
0781-2076-10007812076101000 CAPSULE in 1 BOTTLE (0781-2076-10) 1000 capsule2010-04-270000-00-00NoNoCurrent
0781-2076-920078120769290 CAPSULE in 1 BOTTLE (0781-2076-92) 90 capsule2019-01-310000-00-00NoNoCurrent