FDA.reportPublic FDA data

Tamsulosin Hydrochloride

Product NDC
71610-724
11-digit product format
716100724
Labeler code
71610
Product ID
71610-724_fa62b406-5269-47dd-8787-8d6dc54e018b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tamsulosin Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
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
ae349df8-97ce-a639-ed32-50a4cb01b1bdProduct name420200313

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71610-724-30Tamsulosin Hydrochloride30 in 1 BOTTLECAPSULE301
71610-724-53Tamsulosin Hydrochloride60 in 1 BOTTLECAPSULE601
71610-724-60Tamsulosin Hydrochloride90 in 1 BOTTLECAPSULE901
71610-724-70Tamsulosin Hydrochloride120 in 1 BOTTLECAPSULE1201
71610-724-80Tamsulosin Hydrochloride180 in 1 BOTTLECAPSULE1801

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-724-30EA - Each71610-7245d03248c-4a95-4e61-b634-f6c16b2f457512023-10-16
71610-724-53EA - Each71610-724cad20411-c85a-464a-abc1-79740fcfeb5012023-10-16
71610-724-60EA - Each71610-724cfff774b-90fa-4a4c-903c-811f14bd820f12023-10-16
71610-724-70EA - Each71610-724e7781bcd-6de8-493b-b92f-f32cb9ceab5d12023-10-16
71610-724-80EA - Each71610-724c9506987-0be2-498e-b2b6-90dbe0de705c12023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-724TAMSULOSIN HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Current NDC, 5 package rows20230815_c963384e-eb50-4462-9aea-ed9d26d267d6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
863669tamsulosin HCl 0.4 MG Oral CapsulePSNc963384e-eb50-4462-9aea-ed9d26d267d61
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCDc963384e-eb50-4462-9aea-ed9d26d267d61
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSYc963384e-eb50-4462-9aea-ed9d26d267d61

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71610-724-307161007243030 CAPSULE in 1 BOTTLE (71610-724-30) 30 capsule2023-08-11NoNoCurrent
71610-724-537161007245360 CAPSULE in 1 BOTTLE (71610-724-53) 60 capsule2023-08-11NoNoCurrent
71610-724-607161007246090 CAPSULE in 1 BOTTLE (71610-724-60) 90 capsule2023-08-11NoNoCurrent
71610-724-7071610072470120 CAPSULE in 1 BOTTLE (71610-724-70) 120 capsule2023-08-11NoNoCurrent
71610-724-8071610072480180 CAPSULE in 1 BOTTLE (71610-724-80) 180 capsule2023-08-11NoNoCurrent