avodart

Generic: dutasteride

Labeler: waylis therapeutics llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name avodart
Generic Name dutasteride
Labeler waylis therapeutics llc
Dosage Form CAPSULE, LIQUID FILLED
Routes
ORAL
Active Ingredients

dutasteride .5 mg/1

Manufacturer
Waylis Therapeutics LLC

Identifiers & Regulatory

Product NDC 80725-712
Product ID 80725-712_52039b4d-0202-4d5b-8790-352d254525d1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021319
Listing Expiration 2026-12-31
Marketing Start 2022-12-15

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 80725712
Hyphenated Format 80725-712

Supplemental Identifiers

RxCUI
351172 352118
UPC
0380725712045
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 avodart (source: ndc)
Generic Name dutasteride (source: ndc)
Application Number NDA021319 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .5 mg/1
source: ndc
Packaging
  • 90 CAPSULE, LIQUID FILLED in 1 BOTTLE (80725-712-04)
  • 30 CAPSULE, LIQUID FILLED in 1 BOTTLE (80725-712-15)
source: ndc

Packages (2)

80725-712-04 90 CAPSULE, LIQUID FILLED in 1 BOTTLE (80725-712-04) 80725-712-15 30 CAPSULE, LIQUID FILLED in 1 BOTTLE (80725-712-15)

Ingredients (1)

dutasteride (.5 mg/1)

Linked Drug Pages (1)

AVODART ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "52039b4d-0202-4d5b-8790-352d254525d1", "openfda": {"nui": ["N0000175836", "N0000000126"], "upc": ["0380725712045"], "unii": ["O0J6XJN02I"], "rxcui": ["351172", "352118"], "spl_set_id": ["960797b3-09b1-4d6a-8ece-8b5d918e93e4"], "pharm_class_epc": ["5-alpha Reductase Inhibitor [EPC]"], "pharm_class_moa": ["5-alpha Reductase Inhibitors [MoA]"], "manufacturer_name": ["Waylis Therapeutics LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 CAPSULE, LIQUID FILLED in 1 BOTTLE (80725-712-04)", "package_ndc": "80725-712-04", "marketing_start_date": "20221215"}, {"sample": false, "description": "30 CAPSULE, LIQUID FILLED in 1 BOTTLE (80725-712-15)", "package_ndc": "80725-712-15", "marketing_start_date": "20221215"}], "brand_name": "AVODART", "product_id": "80725-712_52039b4d-0202-4d5b-8790-352d254525d1", "dosage_form": "CAPSULE, LIQUID FILLED", "pharm_class": ["5-alpha Reductase Inhibitor [EPC]", "5-alpha Reductase Inhibitors [MoA]"], "product_ndc": "80725-712", "generic_name": "dutasteride", "labeler_name": "Waylis Therapeutics LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "AVODART", "active_ingredients": [{"name": "DUTASTERIDE", "strength": ".5 mg/1"}], "application_number": "NDA021319", "marketing_category": "NDA", "marketing_start_date": "20221215", "listing_expiration_date": "20261231"}