dutasteride

Generic: dutasteride

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

Drug Facts

Product Profile

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

dutasteride .5 mg/1

Manufacturer
NuCare Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 68071-3857
Product ID 68071-3857_369f6e89-c1f9-4efe-e063-6394a90a920d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209909
Listing Expiration 2026-12-31
Marketing Start 2017-11-28

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 680713857
Hyphenated Format 68071-3857

Supplemental Identifiers

RxCUI
351172
UPC
0368071385793
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 ANDA209909 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .5 mg/1
source: ndc
Packaging
  • 90 CAPSULE, LIQUID FILLED in 1 BOTTLE (68071-3857-9)
source: ndc

Packages (1)

68071-3857-9 90 CAPSULE, LIQUID FILLED in 1 BOTTLE (68071-3857-9)

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": "369f6e89-c1f9-4efe-e063-6394a90a920d", "openfda": {"nui": ["N0000175836", "N0000000126"], "upc": ["0368071385793"], "unii": ["O0J6XJN02I"], "rxcui": ["351172"], "spl_set_id": ["369f73b9-e032-4315-e063-6294a90a4ca1"], "pharm_class_epc": ["5-alpha Reductase Inhibitor [EPC]"], "pharm_class_moa": ["5-alpha Reductase Inhibitors [MoA]"], "manufacturer_name": ["NuCare Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "90 CAPSULE, LIQUID FILLED in 1 BOTTLE (68071-3857-9)", "package_ndc": "68071-3857-9", "marketing_start_date": "20250602"}], "brand_name": "Dutasteride", "product_id": "68071-3857_369f6e89-c1f9-4efe-e063-6394a90a920d", "dosage_form": "CAPSULE, LIQUID FILLED", "pharm_class": ["5-alpha Reductase Inhibitor [EPC]", "5-alpha Reductase Inhibitors [MoA]"], "product_ndc": "68071-3857", "generic_name": "Dutasteride", "labeler_name": "NuCare Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dutasteride", "active_ingredients": [{"name": "DUTASTERIDE", "strength": ".5 mg/1"}], "application_number": "ANDA209909", "marketing_category": "ANDA", "marketing_start_date": "20171128", "listing_expiration_date": "20261231"}