FDA.reportPublic FDA data

Tamsulosin hydrochloride

Product NDC
71610-910
11-digit product format
716100910
Labeler code
71610
Product ID
71610-910_35bbb655-19e3-00c2-e063-6394a90afbe3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tamsulosin hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA078801
Marketing category
ANDA
Marketing start
2024-03-01
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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
ae349df8-97ce-a639-ed32-50a4cb01b1bdProduct name420200313

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71610-910-30Tamsulosin hydrochloride30 in 1 BOTTLECAPSULE301
71610-910-53Tamsulosin hydrochloride60 in 1 BOTTLECAPSULE601
71610-910-60Tamsulosin hydrochloride90 in 1 BOTTLECAPSULE901
71610-910-70Tamsulosin hydrochloride120 in 1 BOTTLECAPSULE1201
71610-910-80Tamsulosin hydrochloride180 in 1 BOTTLECAPSULE1801

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-910-30EA - Each71610-910fdcf9855-30bf-4300-8fd2-1c832769992a12025-07-08
71610-910-53EA - Each71610-91041e12a5a-220c-477c-8cbc-435b75a5431312025-07-08
71610-910-60EA - Each71610-9108d109b2d-0849-4046-807a-6c5901c38b4d12025-07-08
71610-910-70EA - Each71610-9101103e2c2-ef6e-404b-b5b2-8b5b646c557c12025-07-08
71610-910-80EA - Each71610-91017c775bf-dca0-4645-8b64-95e6c1b45ad512025-07-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-910TAMSULOSIN HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC ]1Current NDC, 5 package rows20250529_35bbb655-19e2-00c2-e063-6394a90afbe3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
863669tamsulosin HCl 0.4 MG Oral CapsulePSN35bbb655-19e2-00c2-e063-6394a90afbe31
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCD35bbb655-19e2-00c2-e063-6394a90afbe31
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSY35bbb655-19e2-00c2-e063-6394a90afbe31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71610-910-307161009103030 CAPSULE in 1 BOTTLE (71610-910-30) 30 capsule2025-05-20NoNoCurrent
71610-910-537161009105360 CAPSULE in 1 BOTTLE (71610-910-53) 60 capsule2025-05-20NoNoCurrent
71610-910-607161009106090 CAPSULE in 1 BOTTLE (71610-910-60) 90 capsule2025-05-20NoNoCurrent
71610-910-7071610091070120 CAPSULE in 1 BOTTLE (71610-910-70) 120 capsule2025-05-20NoNoCurrent
71610-910-8071610091080180 CAPSULE in 1 BOTTLE (71610-910-80) 180 capsule2025-05-20NoNoCurrent