dutasteride

Generic: dutasteride

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

Drug Facts

Product Profile

Brand Name dutasteride
Generic Name dutasteride
Labeler epic pharma, llc
Dosage Form CAPSULE, LIQUID FILLED
Routes
ORAL
Active Ingredients

dutasteride .5 mg/1

Manufacturer
Epic Pharma, LLC

Identifiers & Regulatory

Product NDC 42806-549
Product ID 42806-549_2b367985-feb6-bf97-e063-6294a90aede5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209909
Listing Expiration 2026-12-31
Marketing Start 2017-11-28

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 42806549
Hyphenated Format 42806-549

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 ANDA209909 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .5 mg/1
source: ndc
Packaging
  • 90 CAPSULE, LIQUID FILLED in 1 BOTTLE (42806-549-09)
  • 30 CAPSULE, LIQUID FILLED in 1 BOTTLE (42806-549-30)
source: ndc

Packages (2)

42806-549-09 90 CAPSULE, LIQUID FILLED in 1 BOTTLE (42806-549-09) 42806-549-30 30 CAPSULE, LIQUID FILLED in 1 BOTTLE (42806-549-30)

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": "2b367985-feb6-bf97-e063-6294a90aede5", "openfda": {"nui": ["N0000175836", "N0000000126"], "unii": ["O0J6XJN02I"], "rxcui": ["351172"], "spl_set_id": ["2ee1eef5-8ec7-46c1-b4fa-13184915448f"], "pharm_class_epc": ["5-alpha Reductase Inhibitor [EPC]"], "pharm_class_moa": ["5-alpha Reductase Inhibitors [MoA]"], "manufacturer_name": ["Epic Pharma, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 CAPSULE, LIQUID FILLED in 1 BOTTLE (42806-549-09)", "package_ndc": "42806-549-09", "marketing_start_date": "20171128"}, {"sample": false, "description": "30 CAPSULE, LIQUID FILLED in 1 BOTTLE (42806-549-30)", "package_ndc": "42806-549-30", "marketing_start_date": "20171128"}], "brand_name": "Dutasteride", "product_id": "42806-549_2b367985-feb6-bf97-e063-6294a90aede5", "dosage_form": "CAPSULE, LIQUID FILLED", "pharm_class": ["5-alpha Reductase Inhibitor [EPC]", "5-alpha Reductase Inhibitors [MoA]"], "product_ndc": "42806-549", "generic_name": "Dutasteride", "labeler_name": "Epic Pharma, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dutasteride", "active_ingredients": [{"name": "DUTASTERIDE", "strength": ".5 mg/1"}], "application_number": "ANDA209909", "marketing_category": "ANDA", "marketing_start_date": "20171128", "listing_expiration_date": "20261231"}