dutasteride

Generic: dutasteride

Labeler: amneal pharmaceuticals llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dutasteride
Generic Name dutasteride
Labeler amneal pharmaceuticals llc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

dutasteride .5 mg/1

Manufacturer
Amneal Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 65162-750
Product ID 65162-750_d1ac003d-2e58-4a30-8072-8419e7ebb4c6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203118
Listing Expiration 2026-12-31
Marketing Start 2015-11-02

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 65162750
Hyphenated Format 65162-750

Supplemental Identifiers

RxCUI
351172
UPC
0365162750096 0365162750034
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 ANDA203118 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .5 mg/1
source: ndc
Packaging
  • 30 CAPSULE in 1 BOTTLE (65162-750-03)
  • 90 CAPSULE in 1 BOTTLE (65162-750-09)
source: ndc

Packages (2)

65162-750-03 30 CAPSULE in 1 BOTTLE (65162-750-03) 65162-750-09 90 CAPSULE in 1 BOTTLE (65162-750-09)

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": "d1ac003d-2e58-4a30-8072-8419e7ebb4c6", "openfda": {"nui": ["N0000175836", "N0000000126"], "upc": ["0365162750096", "0365162750034"], "unii": ["O0J6XJN02I"], "rxcui": ["351172"], "spl_set_id": ["e537c60d-9ba2-4e7f-a405-2b915dcd7ead"], "pharm_class_epc": ["5-alpha Reductase Inhibitor [EPC]"], "pharm_class_moa": ["5-alpha Reductase Inhibitors [MoA]"], "manufacturer_name": ["Amneal Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE in 1 BOTTLE (65162-750-03)", "package_ndc": "65162-750-03", "marketing_start_date": "20151102"}, {"sample": false, "description": "90 CAPSULE in 1 BOTTLE (65162-750-09)", "package_ndc": "65162-750-09", "marketing_start_date": "20151102"}], "brand_name": "Dutasteride", "product_id": "65162-750_d1ac003d-2e58-4a30-8072-8419e7ebb4c6", "dosage_form": "CAPSULE", "pharm_class": ["5-alpha Reductase Inhibitor [EPC]", "5-alpha Reductase Inhibitors [MoA]"], "product_ndc": "65162-750", "generic_name": "Dutasteride", "labeler_name": "Amneal Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dutasteride", "active_ingredients": [{"name": "DUTASTERIDE", "strength": ".5 mg/1"}], "application_number": "ANDA203118", "marketing_category": "ANDA", "marketing_start_date": "20151102", "listing_expiration_date": "20261231"}