finasteride

Generic: finasteride

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name finasteride
Generic Name finasteride
Labeler aurobindo pharma limited
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

finasteride 5 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 65862-149
Product ID 65862-149_ed41c3ea-c116-49d8-8e22-5a9be9fe4f61
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078341
Listing Expiration 2026-12-31
Marketing Start 2007-10-30

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 65862149
Hyphenated Format 65862-149

Supplemental Identifiers

RxCUI
310346
UNII
57GNO57U7G
NUI
N0000175836 N0000000126

Packaging Origin

Original Packager
true

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 ANDA078341 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (65862-149-01)
  • 500 TABLET, FILM COATED in 1 BOTTLE (65862-149-05)
  • 30 TABLET, FILM COATED in 1 BOTTLE (65862-149-30)
  • 90 TABLET, FILM COATED in 1 BOTTLE (65862-149-90)
source: ndc

Packages (4)

65862-149-01 100 TABLET, FILM COATED in 1 BOTTLE (65862-149-01) 65862-149-05 500 TABLET, FILM COATED in 1 BOTTLE (65862-149-05) 65862-149-30 30 TABLET, FILM COATED in 1 BOTTLE (65862-149-30) 65862-149-90 90 TABLET, FILM COATED in 1 BOTTLE (65862-149-90)

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": "ed41c3ea-c116-49d8-8e22-5a9be9fe4f61", "openfda": {"nui": ["N0000175836", "N0000000126"], "unii": ["57GNO57U7G"], "rxcui": ["310346"], "spl_set_id": ["32266029-c710-44dd-943f-7e31d0afa622"], "pharm_class_epc": ["5-alpha Reductase Inhibitor [EPC]"], "pharm_class_moa": ["5-alpha Reductase Inhibitors [MoA]"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (65862-149-01)", "package_ndc": "65862-149-01", "marketing_start_date": "20071030"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (65862-149-05)", "package_ndc": "65862-149-05", "marketing_start_date": "20071030"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (65862-149-30)", "package_ndc": "65862-149-30", "marketing_start_date": "20071030"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (65862-149-90)", "package_ndc": "65862-149-90", "marketing_start_date": "20071030"}], "brand_name": "Finasteride", "product_id": "65862-149_ed41c3ea-c116-49d8-8e22-5a9be9fe4f61", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["5-alpha Reductase Inhibitor [EPC]", "5-alpha Reductase Inhibitors [MoA]"], "product_ndc": "65862-149", "generic_name": "Finasteride", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Finasteride", "active_ingredients": [{"name": "FINASTERIDE", "strength": "5 mg/1"}], "application_number": "ANDA078341", "marketing_category": "ANDA", "marketing_start_date": "20071030", "listing_expiration_date": "20261231"}