dutasteride

Generic: dutasteride

Labeler: bryant ranch prepack
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dutasteride
Generic Name dutasteride
Labeler bryant ranch prepack
Dosage Form CAPSULE, LIQUID FILLED
Routes
ORAL
Active Ingredients

dutasteride .5 mg/1

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 63629-8207
Product ID 63629-8207_b9adcc68-e71a-4805-aa88-80d2d4ddfcbc
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 636298207
Hyphenated Format 63629-8207

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 (63629-8207-1)
  • 90 CAPSULE, LIQUID FILLED in 1 BOTTLE (63629-8207-2)
  • 180 CAPSULE, LIQUID FILLED in 1 BOTTLE (63629-8207-3)
source: ndc

Packages (3)

63629-8207-1 30 CAPSULE, LIQUID FILLED in 1 BOTTLE (63629-8207-1) 63629-8207-2 90 CAPSULE, LIQUID FILLED in 1 BOTTLE (63629-8207-2) 63629-8207-3 180 CAPSULE, LIQUID FILLED in 1 BOTTLE (63629-8207-3)

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": "b9adcc68-e71a-4805-aa88-80d2d4ddfcbc", "openfda": {"nui": ["N0000175836", "N0000000126"], "unii": ["O0J6XJN02I"], "rxcui": ["351172"], "spl_set_id": ["170f01fe-5048-413c-b4cd-8311e1a2728a"], "pharm_class_epc": ["5-alpha Reductase Inhibitor [EPC]"], "pharm_class_moa": ["5-alpha Reductase Inhibitors [MoA]"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE, LIQUID FILLED in 1 BOTTLE (63629-8207-1)", "package_ndc": "63629-8207-1", "marketing_start_date": "20190801"}, {"sample": false, "description": "90 CAPSULE, LIQUID FILLED in 1 BOTTLE (63629-8207-2)", "package_ndc": "63629-8207-2", "marketing_start_date": "20200722"}, {"sample": false, "description": "180 CAPSULE, LIQUID FILLED in 1 BOTTLE (63629-8207-3)", "package_ndc": "63629-8207-3", "marketing_start_date": "20220411"}], "brand_name": "Dutasteride", "product_id": "63629-8207_b9adcc68-e71a-4805-aa88-80d2d4ddfcbc", "dosage_form": "CAPSULE, LIQUID FILLED", "pharm_class": ["5-alpha Reductase Inhibitor [EPC]", "5-alpha Reductase Inhibitors [MoA]"], "product_ndc": "63629-8207", "generic_name": "Dutasteride", "labeler_name": "Bryant Ranch Prepack", "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"}