dutasteride

Generic: dutasteride

Labeler: xlcare pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dutasteride
Generic Name dutasteride
Labeler xlcare pharmaceuticals, inc.
Dosage Form CAPSULE, LIQUID FILLED
Routes
ORAL
Active Ingredients

dutasteride .5 mg/1

Manufacturer
XLCare Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 72865-140
Product ID 72865-140_64c4cfd9-a320-49f6-ae29-ed9a1f1e3789
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206574
Listing Expiration 2026-12-31
Marketing Start 2020-03-09

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 72865140
Hyphenated Format 72865-140

Supplemental Identifiers

RxCUI
351172
UPC
0372865140307 0372865140901
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 ANDA206574 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .5 mg/1
source: ndc
Packaging
  • 30 CAPSULE, LIQUID FILLED in 1 BOTTLE (72865-140-30)
  • 90 CAPSULE, LIQUID FILLED in 1 BOTTLE (72865-140-90)
source: ndc

Packages (2)

72865-140-30 30 CAPSULE, LIQUID FILLED in 1 BOTTLE (72865-140-30) 72865-140-90 90 CAPSULE, LIQUID FILLED in 1 BOTTLE (72865-140-90)

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": "64c4cfd9-a320-49f6-ae29-ed9a1f1e3789", "openfda": {"nui": ["N0000175836", "N0000000126"], "upc": ["0372865140307", "0372865140901"], "unii": ["O0J6XJN02I"], "rxcui": ["351172"], "spl_set_id": ["40ddf119-b0a5-4375-9285-d50a24ed1532"], "pharm_class_epc": ["5-alpha Reductase Inhibitor [EPC]"], "pharm_class_moa": ["5-alpha Reductase Inhibitors [MoA]"], "manufacturer_name": ["XLCare Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE, LIQUID FILLED in 1 BOTTLE (72865-140-30)", "package_ndc": "72865-140-30", "marketing_start_date": "20200309"}, {"sample": false, "description": "90 CAPSULE, LIQUID FILLED in 1 BOTTLE (72865-140-90)", "package_ndc": "72865-140-90", "marketing_start_date": "20200309"}], "brand_name": "Dutasteride", "product_id": "72865-140_64c4cfd9-a320-49f6-ae29-ed9a1f1e3789", "dosage_form": "CAPSULE, LIQUID FILLED", "pharm_class": ["5-alpha Reductase Inhibitor [EPC]", "5-alpha Reductase Inhibitors [MoA]"], "product_ndc": "72865-140", "generic_name": "Dutasteride", "labeler_name": "XLCare Pharmaceuticals, Inc.", "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": "20200309", "listing_expiration_date": "20261231"}