dutasteride

Generic: dutasteride

Labeler: banyan pharma llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dutasteride
Generic Name dutasteride
Labeler banyan pharma llc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

dutasteride .5 mg/1

Manufacturer
Banyan Pharma LLC

Identifiers & Regulatory

Product NDC 84091-100
Product ID 84091-100_372f7766-bcc0-4eaa-8593-e29c0c6dcff7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204705
Listing Expiration 2026-12-31
Marketing Start 2025-12-31

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 84091100
Hyphenated Format 84091-100

Supplemental Identifiers

RxCUI
351172
UNII
O0J6XJN02I
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 (source: ndc)
Generic Name dutasteride (source: ndc)
Application Number ANDA204705 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .5 mg/1
source: ndc
Packaging
  • 90 CAPSULE in 1 BOTTLE (84091-100-90)
source: ndc

Packages (1)

84091-100-90 90 CAPSULE in 1 BOTTLE (84091-100-90)

Ingredients (1)

dutasteride (.5 mg/1)

Linked Drug Pages (1)

DUTASTERIDE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "372f7766-bcc0-4eaa-8593-e29c0c6dcff7", "openfda": {"nui": ["N0000175836", "N0000000126"], "unii": ["O0J6XJN02I"], "rxcui": ["351172"], "spl_set_id": ["947644ea-bc35-41df-8a7a-874360c90192"], "pharm_class_epc": ["5-alpha Reductase Inhibitor [EPC]"], "pharm_class_moa": ["5-alpha Reductase Inhibitors [MoA]"], "manufacturer_name": ["Banyan Pharma LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 CAPSULE in 1 BOTTLE (84091-100-90)", "package_ndc": "84091-100-90", "marketing_start_date": "20251231"}], "brand_name": "DUTASTERIDE", "product_id": "84091-100_372f7766-bcc0-4eaa-8593-e29c0c6dcff7", "dosage_form": "CAPSULE", "pharm_class": ["5-alpha Reductase Inhibitor [EPC]", "5-alpha Reductase Inhibitors [MoA]"], "product_ndc": "84091-100", "generic_name": "DUTASTERIDE", "labeler_name": "Banyan Pharma LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "DUTASTERIDE", "active_ingredients": [{"name": "DUTASTERIDE", "strength": ".5 mg/1"}], "application_number": "ANDA204705", "marketing_category": "ANDA", "marketing_start_date": "20251231", "listing_expiration_date": "20261231"}