finasteride

Generic: finasteride

Labeler: aphena pharma solutions - tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name finasteride
Generic Name finasteride
Labeler aphena pharma solutions - tennessee, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

finasteride 5 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 71610-520
Product ID 71610-520_ab63782b-6982-4cd8-a80f-e8f3da372177
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204304
Listing Expiration 2026-12-31
Marketing Start 2017-01-05

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 71610520
Hyphenated Format 71610-520

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 ANDA204304 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (71610-520-30)
  • 90 TABLET, FILM COATED in 1 BOTTLE (71610-520-60)
source: ndc

Packages (2)

71610-520-30 30 TABLET, FILM COATED in 1 BOTTLE (71610-520-30) 71610-520-60 90 TABLET, FILM COATED in 1 BOTTLE (71610-520-60)

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": "ab63782b-6982-4cd8-a80f-e8f3da372177", "openfda": {"nui": ["N0000175836", "N0000000126"], "unii": ["57GNO57U7G"], "rxcui": ["310346"], "spl_set_id": ["845cad9c-c50d-4c98-8df8-893d1241836a"], "pharm_class_epc": ["5-alpha Reductase Inhibitor [EPC]"], "pharm_class_moa": ["5-alpha Reductase Inhibitors [MoA]"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (71610-520-30)", "package_ndc": "71610-520-30", "marketing_start_date": "20220222"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (71610-520-60)", "package_ndc": "71610-520-60", "marketing_start_date": "20210127"}], "brand_name": "Finasteride", "product_id": "71610-520_ab63782b-6982-4cd8-a80f-e8f3da372177", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["5-alpha Reductase Inhibitor [EPC]", "5-alpha Reductase Inhibitors [MoA]"], "product_ndc": "71610-520", "generic_name": "Finasteride", "labeler_name": "Aphena Pharma Solutions - Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Finasteride", "active_ingredients": [{"name": "FINASTERIDE", "strength": "5 mg/1"}], "application_number": "ANDA204304", "marketing_category": "ANDA", "marketing_start_date": "20170105", "listing_expiration_date": "20261231"}