FDA.reportPublic FDA data

Tamsulosin Hydrochloride

Product NDC
71610-738
11-digit product format
716100738
Labeler code
71610
Product ID
71610-738_0df2d4c9-cc71-47ff-afb4-e2f49e551d75
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tamsulosin Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
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
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
71610-738-30Tamsulosin Hydrochloride30 in 1 BOTTLECAPSULE302
71610-738-53Tamsulosin Hydrochloride60 in 1 BOTTLECAPSULE602
71610-738-60Tamsulosin Hydrochloride90 in 1 BOTTLECAPSULE902
71610-738-70Tamsulosin Hydrochloride120 in 1 BOTTLECAPSULE1202
71610-738-80Tamsulosin Hydrochloride180 in 1 BOTTLECAPSULE1802

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-738-30EA - Each71610-73849791c37-c2a6-4e0d-85e9-874471cf342d12023-12-05
71610-738-60EA - Each71610-73850ede59f-2813-4b93-893d-4397374d102412023-12-05
71610-738-70EA - Each71610-73835463f16-7452-4865-a5fe-3d3b477fa38412023-12-05
71610-738-80EA - Each71610-738c826468d-4cf4-42e7-b651-05069a93f92a12023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-738TAMSULOSIN HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2Current NDC, 5 package rows20230927_e0ad49c7-f57c-45c6-9084-16d8b79c8f87.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
863669tamsulosin HCl 0.4 MG Oral CapsulePSNe0ad49c7-f57c-45c6-9084-16d8b79c8f872
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCDe0ad49c7-f57c-45c6-9084-16d8b79c8f872
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSYe0ad49c7-f57c-45c6-9084-16d8b79c8f872

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71610-738-307161007383030 CAPSULE in 1 BOTTLE (71610-738-30) 30 capsule2023-09-22NoNoCurrent
71610-738-537161007385360 CAPSULE in 1 BOTTLE (71610-738-53) 60 capsule2023-09-22NoNoCurrent
71610-738-607161007386090 CAPSULE in 1 BOTTLE (71610-738-60) 90 capsule2023-09-22NoNoCurrent
71610-738-7071610073870120 CAPSULE in 1 BOTTLE (71610-738-70) 120 capsule2023-09-22NoNoCurrent
71610-738-8071610073880180 CAPSULE in 1 BOTTLE (71610-738-80) 180 capsule2023-09-22NoNoCurrent