finasteride

Generic: finasteride

Labeler: ncs healthcare of ky, llc dba vangard labs
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name finasteride
Generic Name finasteride
Labeler ncs healthcare of ky, llc dba vangard labs
Dosage Form TABLET
Routes
ORAL
Active Ingredients

finasteride 5 mg/1

Manufacturer
NCS HealthCare of KY, LLC dba Vangard Labs

Identifiers & Regulatory

Product NDC 0615-8562
Product ID 0615-8562_4e1dfb0e-d523-48d2-8c82-c80ee2b49800
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076437
Listing Expiration 2026-12-31
Marketing Start 2007-02-28

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 06158562
Hyphenated Format 0615-8562

Supplemental Identifiers

RxCUI
310346
UNII
57GNO57U7G
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 finasteride (source: ndc)
Generic Name finasteride (source: ndc)
Application Number ANDA076437 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 15 TABLET in 1 BLISTER PACK (0615-8562-05)
  • 30 TABLET in 1 BLISTER PACK (0615-8562-39)
source: ndc

Packages (2)

0615-8562-05 15 TABLET in 1 BLISTER PACK (0615-8562-05) 0615-8562-39 30 TABLET in 1 BLISTER PACK (0615-8562-39)

Ingredients (1)

finasteride (5 mg/1)

Linked Drug Pages (1)

Finasteride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4e1dfb0e-d523-48d2-8c82-c80ee2b49800", "openfda": {"nui": ["N0000175836", "N0000000126"], "unii": ["57GNO57U7G"], "rxcui": ["310346"], "spl_set_id": ["8c3b1f6b-0010-4432-8eda-4af3c3573063"], "pharm_class_epc": ["5-alpha Reductase Inhibitor [EPC]"], "pharm_class_moa": ["5-alpha Reductase Inhibitors [MoA]"], "manufacturer_name": ["NCS HealthCare of KY, LLC dba Vangard Labs"]}, "finished": true, "packaging": [{"sample": false, "description": "15 TABLET in 1 BLISTER PACK (0615-8562-05)", "package_ndc": "0615-8562-05", "marketing_start_date": "20250211"}, {"sample": false, "description": "30 TABLET in 1 BLISTER PACK (0615-8562-39)", "package_ndc": "0615-8562-39", "marketing_start_date": "20250211"}], "brand_name": "Finasteride", "product_id": "0615-8562_4e1dfb0e-d523-48d2-8c82-c80ee2b49800", "dosage_form": "TABLET", "pharm_class": ["5-alpha Reductase Inhibitor [EPC]", "5-alpha Reductase Inhibitors [MoA]"], "product_ndc": "0615-8562", "generic_name": "Finasteride", "labeler_name": "NCS HealthCare of KY, LLC dba Vangard Labs", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Finasteride", "active_ingredients": [{"name": "FINASTERIDE", "strength": "5 mg/1"}], "application_number": "ANDA076437", "marketing_category": "ANDA", "marketing_start_date": "20070228", "listing_expiration_date": "20261231"}