finasteride

Generic: finasteride

Labeler: nucare pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name finasteride
Generic Name finasteride
Labeler nucare pharmaceuticals, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

finasteride 5 mg/1

Manufacturer
NuCare Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 68071-3785
Product ID 68071-3785_40bd923b-50f8-c9dd-e063-6294a90a71f3
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 680713785
Hyphenated Format 68071-3785

Supplemental Identifiers

RxCUI
310346
UPC
0368071378580
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 ANDA078341 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 120 TABLET, FILM COATED in 1 BOTTLE (68071-3785-2)
  • 60 TABLET, FILM COATED in 1 BOTTLE (68071-3785-6)
  • 180 TABLET, FILM COATED in 1 BOTTLE (68071-3785-8)
source: ndc

Packages (3)

68071-3785-2 120 TABLET, FILM COATED in 1 BOTTLE (68071-3785-2) 68071-3785-6 60 TABLET, FILM COATED in 1 BOTTLE (68071-3785-6) 68071-3785-8 180 TABLET, FILM COATED in 1 BOTTLE (68071-3785-8)

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": "40bd923b-50f8-c9dd-e063-6294a90a71f3", "openfda": {"nui": ["N0000175836", "N0000000126"], "upc": ["0368071378580"], "unii": ["57GNO57U7G"], "rxcui": ["310346"], "spl_set_id": ["2c688ec5-1b0f-2269-e063-6394a90a7220"], "pharm_class_epc": ["5-alpha Reductase Inhibitor [EPC]"], "pharm_class_moa": ["5-alpha Reductase Inhibitors [MoA]"], "manufacturer_name": ["NuCare Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "120 TABLET, FILM COATED in 1 BOTTLE (68071-3785-2)", "package_ndc": "68071-3785-2", "marketing_start_date": "20250123"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (68071-3785-6)", "package_ndc": "68071-3785-6", "marketing_start_date": "20251009"}, {"sample": false, "description": "180 TABLET, FILM COATED in 1 BOTTLE (68071-3785-8)", "package_ndc": "68071-3785-8", "marketing_start_date": "20250123"}], "brand_name": "Finasteride", "product_id": "68071-3785_40bd923b-50f8-c9dd-e063-6294a90a71f3", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["5-alpha Reductase Inhibitor [EPC]", "5-alpha Reductase Inhibitors [MoA]"], "product_ndc": "68071-3785", "generic_name": "Finasteride", "labeler_name": "NuCare Pharmaceuticals, Inc.", "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"}