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 1 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 65862-927
Product ID 65862-927_92ac09b3-d036-4c90-81e6-c13310f0a673
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203687
Listing Expiration 2026-12-31
Marketing Start 2014-09-20

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 65862927
Hyphenated Format 65862-927

Supplemental Identifiers

RxCUI
200172
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 ANDA203687 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (65862-927-30)
  • 90 TABLET, FILM COATED in 1 BOTTLE (65862-927-90)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (65862-927-99)
source: ndc

Packages (3)

65862-927-30 30 TABLET, FILM COATED in 1 BOTTLE (65862-927-30) 65862-927-90 90 TABLET, FILM COATED in 1 BOTTLE (65862-927-90) 65862-927-99 1000 TABLET, FILM COATED in 1 BOTTLE (65862-927-99)

Ingredients (1)

finasteride (1 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": "92ac09b3-d036-4c90-81e6-c13310f0a673", "openfda": {"nui": ["N0000175836", "N0000000126"], "unii": ["57GNO57U7G"], "rxcui": ["200172"], "spl_set_id": ["7d140366-2388-488e-bd86-67e6edf44345"], "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": "30 TABLET, FILM COATED in 1 BOTTLE (65862-927-30)", "package_ndc": "65862-927-30", "marketing_start_date": "20140920"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (65862-927-90)", "package_ndc": "65862-927-90", "marketing_start_date": "20140920"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (65862-927-99)", "package_ndc": "65862-927-99", "marketing_start_date": "20140920"}], "brand_name": "Finasteride", "product_id": "65862-927_92ac09b3-d036-4c90-81e6-c13310f0a673", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["5-alpha Reductase Inhibitor [EPC]", "5-alpha Reductase Inhibitors [MoA]"], "product_ndc": "65862-927", "generic_name": "Finasteride", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Finasteride", "active_ingredients": [{"name": "FINASTERIDE", "strength": "1 mg/1"}], "application_number": "ANDA203687", "marketing_category": "ANDA", "marketing_start_date": "20140920", "listing_expiration_date": "20261231"}