dutasteride and tamsulosin hydrochloride (59651-063)

Drug Facts

Product Profile

Brand Name dutasteride and tamsulosin hydrochloride

Generic Name dutasteride and tamsulosin hydrochloride

Labeler aurobindo pharma limited

Dosage Form CAPSULE

Routes

ORAL

Active Ingredients

dutasteride .5 mg/1, tamsulosin hydrochloride .4 mg/1

Manufacturer

Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 59651-063

Product ID 59651-063_2ad47033-76f3-447d-8a44-21479e9164c0

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA213300

Listing Expiration 2026-12-31

Marketing Start 2024-07-18

Pharmacologic Class

Established (EPC)

5-alpha reductase inhibitor [epc]

Mechanism of Action

5-alpha reductase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 59651063

Hyphenated Format 59651-063

Supplemental Identifiers

RxCUI

996097

UPC

0359651063903

UNII

O0J6XJN02I 11SV1951MR

NUI

N0000175836 N0000000126

Packaging Origin

Original Packager

true

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 dutasteride and tamsulosin hydrochloride (source: ndc)

Generic Name dutasteride and tamsulosin hydrochloride (source: ndc)

Application Number ANDA213300 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

.5 mg/1
.4 mg/1

source: ndc

Packaging

30 CAPSULE in 1 BOTTLE (59651-063-30)
90 CAPSULE in 1 BOTTLE (59651-063-90)

source: ndc

Packages (2)

59651-063-30 30 CAPSULE in 1 BOTTLE (59651-063-30) 59651-063-90 90 CAPSULE in 1 BOTTLE (59651-063-90)

Ingredients (2)

dutasteride (.5 mg/1) tamsulosin hydrochloride (.4 mg/1)

Linked Drug Pages (1)

Dutasteride and Tamsulosin Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "2ad47033-76f3-447d-8a44-21479e9164c0", "openfda": {"nui": ["N0000175836", "N0000000126"], "upc": ["0359651063903"], "unii": ["O0J6XJN02I", "11SV1951MR"], "rxcui": ["996097"], "spl_set_id": ["2ad47033-76f3-447d-8a44-21479e9164c0"], "pharm_class_epc": ["5-alpha Reductase Inhibitor [EPC]"], "pharm_class_moa": ["5-alpha Reductase Inhibitors [MoA]"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE in 1 BOTTLE (59651-063-30)", "package_ndc": "59651-063-30", "marketing_start_date": "20240718"}, {"sample": false, "description": "90 CAPSULE in 1 BOTTLE (59651-063-90)", "package_ndc": "59651-063-90", "marketing_start_date": "20240718"}], "brand_name": "Dutasteride and Tamsulosin Hydrochloride", "product_id": "59651-063_2ad47033-76f3-447d-8a44-21479e9164c0", "dosage_form": "CAPSULE", "pharm_class": ["5-alpha Reductase Inhibitor [EPC]", "5-alpha Reductase Inhibitors [MoA]", "Adrenergic alpha-Antagonists [MoA]", "alpha-Adrenergic Blocker [EPC]"], "product_ndc": "59651-063", "generic_name": "Dutasteride and Tamsulosin Hydrochloride", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dutasteride and Tamsulosin Hydrochloride", "active_ingredients": [{"name": "DUTASTERIDE", "strength": ".5 mg/1"}, {"name": "TAMSULOSIN HYDROCHLORIDE", "strength": ".4 mg/1"}], "application_number": "ANDA213300", "marketing_category": "ANDA", "marketing_start_date": "20240718", "listing_expiration_date": "20261231"}