finasteride

Generic: finasteride

Labeler: proficient rx lp
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name finasteride
Generic Name finasteride
Labeler proficient rx lp
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

finasteride 5 mg/1

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 63187-265
Product ID 63187-265_8438d683-b2a2-476b-8511-e2b74829e90b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090121
Listing Expiration 2026-12-31
Marketing Start 2010-05-28

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 63187265
Hyphenated Format 63187-265

Supplemental Identifiers

RxCUI
310346
UPC
0363187265304
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 ANDA090121 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 10 TABLET, FILM COATED in 1 BOTTLE (63187-265-10)
  • 30 TABLET, FILM COATED in 1 BOTTLE (63187-265-30)
  • 60 TABLET, FILM COATED in 1 BOTTLE (63187-265-60)
  • 90 TABLET, FILM COATED in 1 BOTTLE (63187-265-90)
source: ndc

Packages (4)

63187-265-10 10 TABLET, FILM COATED in 1 BOTTLE (63187-265-10) 63187-265-30 30 TABLET, FILM COATED in 1 BOTTLE (63187-265-30) 63187-265-60 60 TABLET, FILM COATED in 1 BOTTLE (63187-265-60) 63187-265-90 90 TABLET, FILM COATED in 1 BOTTLE (63187-265-90)

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": "8438d683-b2a2-476b-8511-e2b74829e90b", "openfda": {"nui": ["N0000175836", "N0000000126"], "upc": ["0363187265304"], "unii": ["57GNO57U7G"], "rxcui": ["310346"], "spl_set_id": ["e9ea2f77-11c3-4dbf-bdc4-d1b0e7437990"], "pharm_class_epc": ["5-alpha Reductase Inhibitor [EPC]"], "pharm_class_moa": ["5-alpha Reductase Inhibitors [MoA]"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "10 TABLET, FILM COATED in 1 BOTTLE (63187-265-10)", "package_ndc": "63187-265-10", "marketing_start_date": "20220211"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (63187-265-30)", "package_ndc": "63187-265-30", "marketing_start_date": "20141103"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (63187-265-60)", "package_ndc": "63187-265-60", "marketing_start_date": "20170703"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (63187-265-90)", "package_ndc": "63187-265-90", "marketing_start_date": "20170703"}], "brand_name": "Finasteride", "product_id": "63187-265_8438d683-b2a2-476b-8511-e2b74829e90b", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["5-alpha Reductase Inhibitor [EPC]", "5-alpha Reductase Inhibitors [MoA]"], "product_ndc": "63187-265", "generic_name": "finasteride", "labeler_name": "Proficient Rx LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Finasteride", "active_ingredients": [{"name": "FINASTERIDE", "strength": "5 mg/1"}], "application_number": "ANDA090121", "marketing_category": "ANDA", "marketing_start_date": "20100528", "listing_expiration_date": "20261231"}