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

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
11SV1951MRTAMSULOSIN HYDROCHLORIDE106463-17-6TAMSULOSIN HYDROCHLORIDE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71610-910-307161009103030 CAPSULE in 1 BOTTLE (71610-910-30) 30 capsule2025-05-20NoNoHistorical
71610-910-537161009105360 CAPSULE in 1 BOTTLE (71610-910-53) 60 capsule2025-05-20NoNoHistorical
71610-910-607161009106090 CAPSULE in 1 BOTTLE (71610-910-60) 90 capsule2025-05-20NoNoHistorical
71610-910-7071610091070120 CAPSULE in 1 BOTTLE (71610-910-70) 120 capsule2025-05-20NoNoHistorical
71610-910-8071610091080180 CAPSULE in 1 BOTTLE (71610-910-80) 180 capsule2025-05-20NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Tamsulosin hydrochlorideAphena Pharma Solutions - Tennessee, LLC2025-05-22HUMAN PRESCRIPTION DRUG LABEL1