Tamsulosin Hydrochloride

Product NDC
63187-469
11-digit product format
631870469
Labeler code
63187
Product ID
63187-469_3e498751-4077-47d5-803e-564ffb541dbd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tamsulosin Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA090931
Marketing category
ANDA
Marketing start
2010-07-15
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
63187-469-30Tamsulosin Hydrochloride30 in 1 BOTTLECAPSULE304
63187-469-60Tamsulosin Hydrochloride60 in 1 BOTTLECAPSULE604
63187-469-90Tamsulosin Hydrochloride90 in 1 BOTTLECAPSULE904

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TAMSULOSIN HYDROCHLORIDEACTIVE INGREDIENT11SV1951MRTAMSULOSIN HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]1
TAMSULOSINACTIVE MOIETYG3P28OML5ITAMSULOSIN HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTAMSULOSIN HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKTAMSULOSIN HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675TAMSULOSIN HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTTAMSULOSIN HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]1
GELATININACTIVE INGREDIENT2G86QN327LTAMSULOSIN HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]1
HYPROMELLOSE ACETATE SUCCINATE 16070722 (3 MM2/S)INACTIVE INGREDIENT24P2YXD2PWTAMSULOSIN HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]1
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JTAMSULOSIN HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JTAMSULOSIN HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]1
TALCINACTIVE INGREDIENT7SEV7J4R1UTAMSULOSIN HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTAMSULOSIN HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]1
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMTAMSULOSIN HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-469TAMSULOSIN HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]4Current NDC, Legacy NDC, 3 package rows20210114_bf583b4a-a99c-4e18-a6d1-8609b5db1a3a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
863669tamsulosin HCl 0.4 MG Oral CapsulePSNbf583b4a-a99c-4e18-a6d1-8609b5db1a3a4
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCDbf583b4a-a99c-4e18-a6d1-8609b5db1a3a4
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSYbf583b4a-a99c-4e18-a6d1-8609b5db1a3a4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-469-306318704693030 CAPSULE in 1 BOTTLE (63187-469-30) 30 capsule2015-02-020000-00-00NoNoCurrent
63187-469-606318704696060 CAPSULE in 1 BOTTLE (63187-469-60) 60 capsule2015-02-020000-00-00NoNoCurrent
63187-469-906318704699090 CAPSULE in 1 BOTTLE (63187-469-90) 90 capsule2015-02-020000-00-00NoNoCurrent