dutasteride and tamsulosin hydrochloride (10370-280)

Drug Facts

Product Profile

Brand Name dutasteride and tamsulosin hydrochloride

Generic Name dutasteride and tamsulosin hydrochloride

Labeler endo usa, inc.

Dosage Form CAPSULE

Routes

ORAL

Active Ingredients

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

Manufacturer

Endo USA, Inc.

Identifiers & Regulatory

Product NDC 10370-280

Product ID 10370-280_79eff189-e6e9-477e-beb6-568046fb5043

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA202509

Listing Expiration 2026-12-31

Marketing Start 2015-11-18

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 10370280

Hyphenated Format 10370-280

Supplemental Identifiers

RxCUI

996097

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 ANDA202509 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

.5 mg/1
.4 mg/1

source: ndc

Packaging

90 CAPSULE in 1 BOTTLE (10370-280-09)
30 CAPSULE in 1 BOTTLE (10370-280-11)

source: ndc

Packages (2)

10370-280-09 90 CAPSULE in 1 BOTTLE (10370-280-09) 10370-280-11 30 CAPSULE in 1 BOTTLE (10370-280-11)

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": "79eff189-e6e9-477e-beb6-568046fb5043", "openfda": {"nui": ["N0000175836", "N0000000126"], "unii": ["O0J6XJN02I", "11SV1951MR"], "rxcui": ["996097"], "spl_set_id": ["8c6031b3-b6a8-4ec7-b0d3-286f50d29353"], "pharm_class_epc": ["5-alpha Reductase Inhibitor [EPC]"], "pharm_class_moa": ["5-alpha Reductase Inhibitors [MoA]"], "manufacturer_name": ["Endo USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 CAPSULE in 1 BOTTLE (10370-280-09)", "package_ndc": "10370-280-09", "marketing_start_date": "20151118"}, {"sample": false, "description": "30 CAPSULE in 1 BOTTLE (10370-280-11)", "package_ndc": "10370-280-11", "marketing_start_date": "20151118"}], "brand_name": "Dutasteride and Tamsulosin Hydrochloride", "product_id": "10370-280_79eff189-e6e9-477e-beb6-568046fb5043", "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": "10370-280", "generic_name": "Dutasteride and Tamsulosin Hydrochloride", "labeler_name": "Endo USA, Inc.", "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": "ANDA202509", "marketing_category": "ANDA", "marketing_start_date": "20151118", "listing_expiration_date": "20261231"}