tamsulosin hydrochloride

Generic: tamsulosin hydrochloride

Labeler: aphena pharma solutions - tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tamsulosin hydrochloride
Generic Name tamsulosin hydrochloride
Labeler aphena pharma solutions - tennessee, llc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

tamsulosin hydrochloride .4 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 71610-910
Product ID 71610-910_35bbb655-19e3-00c2-e063-6394a90afbe3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078801
Listing Expiration 2026-12-31
Marketing Start 2024-03-01

Pharmacologic Class

Classes
adrenergic alpha-antagonists [moa] alpha-adrenergic blocker [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71610910
Hyphenated Format 71610-910

Supplemental Identifiers

RxCUI
863669
UNII
11SV1951MR

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name tamsulosin hydrochloride (source: ndc)
Generic Name tamsulosin hydrochloride (source: ndc)
Application Number ANDA078801 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .4 mg/1
source: ndc
Packaging
  • 30 CAPSULE in 1 BOTTLE (71610-910-30)
  • 60 CAPSULE in 1 BOTTLE (71610-910-53)
  • 90 CAPSULE in 1 BOTTLE (71610-910-60)
  • 120 CAPSULE in 1 BOTTLE (71610-910-70)
  • 180 CAPSULE in 1 BOTTLE (71610-910-80)
source: ndc

Packages (5)

71610-910-30 30 CAPSULE in 1 BOTTLE (71610-910-30) 71610-910-53 60 CAPSULE in 1 BOTTLE (71610-910-53) 71610-910-60 90 CAPSULE in 1 BOTTLE (71610-910-60) 71610-910-70 120 CAPSULE in 1 BOTTLE (71610-910-70) 71610-910-80 180 CAPSULE in 1 BOTTLE (71610-910-80)

Ingredients (1)

tamsulosin hydrochloride (.4 mg/1)

Linked Drug Pages (1)

Tamsulosin hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "35bbb655-19e3-00c2-e063-6394a90afbe3", "openfda": {"unii": ["11SV1951MR"], "rxcui": ["863669"], "spl_set_id": ["35bbb655-19e2-00c2-e063-6394a90afbe3"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE in 1 BOTTLE (71610-910-30)", "package_ndc": "71610-910-30", "marketing_start_date": "20250520"}, {"sample": false, "description": "60 CAPSULE in 1 BOTTLE (71610-910-53)", "package_ndc": "71610-910-53", "marketing_start_date": "20250520"}, {"sample": false, "description": "90 CAPSULE in 1 BOTTLE (71610-910-60)", "package_ndc": "71610-910-60", "marketing_start_date": "20250520"}, {"sample": false, "description": "120 CAPSULE in 1 BOTTLE (71610-910-70)", "package_ndc": "71610-910-70", "marketing_start_date": "20250520"}, {"sample": false, "description": "180 CAPSULE in 1 BOTTLE (71610-910-80)", "package_ndc": "71610-910-80", "marketing_start_date": "20250520"}], "brand_name": "Tamsulosin hydrochloride", "product_id": "71610-910_35bbb655-19e3-00c2-e063-6394a90afbe3", "dosage_form": "CAPSULE", "pharm_class": ["Adrenergic alpha-Antagonists [MoA]", "alpha-Adrenergic Blocker [EPC]"], "product_ndc": "71610-910", "generic_name": "Tamsulosin hydrochloride", "labeler_name": "Aphena Pharma Solutions - Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tamsulosin hydrochloride", "active_ingredients": [{"name": "TAMSULOSIN HYDROCHLORIDE", "strength": ".4 mg/1"}], "application_number": "ANDA078801", "marketing_category": "ANDA", "marketing_start_date": "20240301", "listing_expiration_date": "20261231"}