dutasteride

Generic: dutasteride

Labeler: a-s medication solutions
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dutasteride
Generic Name dutasteride
Labeler a-s medication solutions
Dosage Form CAPSULE, LIQUID FILLED
Routes
ORAL
Active Ingredients

dutasteride .5 mg/1

Manufacturer
A-S Medication Solutions

Identifiers & Regulatory

Product NDC 50090-4010
Product ID 50090-4010_20bcd517-c1c4-48be-8cfe-778fdd463d19
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206574
Listing Expiration 2026-12-31
Marketing Start 2016-10-24

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 500904010
Hyphenated Format 50090-4010

Supplemental Identifiers

RxCUI
351172
UNII
O0J6XJN02I
NUI
N0000175836 N0000000126

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 ANDA206574 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .5 mg/1
source: ndc
Packaging
  • 30 CAPSULE, LIQUID FILLED in 1 BOTTLE (50090-4010-0)
  • 90 CAPSULE, LIQUID FILLED in 1 BOTTLE (50090-4010-1)
source: ndc

Packages (2)

50090-4010-0 30 CAPSULE, LIQUID FILLED in 1 BOTTLE (50090-4010-0) 50090-4010-1 90 CAPSULE, LIQUID FILLED in 1 BOTTLE (50090-4010-1)

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": "20bcd517-c1c4-48be-8cfe-778fdd463d19", "openfda": {"nui": ["N0000175836", "N0000000126"], "unii": ["O0J6XJN02I"], "rxcui": ["351172"], "spl_set_id": ["af5e7d42-6953-4b7f-afac-257e9444b0a2"], "pharm_class_epc": ["5-alpha Reductase Inhibitor [EPC]"], "pharm_class_moa": ["5-alpha Reductase Inhibitors [MoA]"], "manufacturer_name": ["A-S Medication Solutions"]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE, LIQUID FILLED in 1 BOTTLE (50090-4010-0)", "package_ndc": "50090-4010-0", "marketing_start_date": "20181228"}, {"sample": false, "description": "90 CAPSULE, LIQUID FILLED in 1 BOTTLE (50090-4010-1)", "package_ndc": "50090-4010-1", "marketing_start_date": "20190701"}], "brand_name": "Dutasteride", "product_id": "50090-4010_20bcd517-c1c4-48be-8cfe-778fdd463d19", "dosage_form": "CAPSULE, LIQUID FILLED", "pharm_class": ["5-alpha Reductase Inhibitor [EPC]", "5-alpha Reductase Inhibitors [MoA]"], "product_ndc": "50090-4010", "generic_name": "Dutasteride", "labeler_name": "A-S Medication Solutions", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dutasteride", "active_ingredients": [{"name": "DUTASTERIDE", "strength": ".5 mg/1"}], "application_number": "ANDA206574", "marketing_category": "ANDA", "marketing_start_date": "20161024", "listing_expiration_date": "20261231"}