finasteride

Generic: finasteride

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

Drug Facts

Product Profile

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

finasteride 5 mg/1

Manufacturer
Preferred Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 68788-8433
Product ID 68788-8433_5d4b1d8d-6e91-42aa-bc00-454a8cf4d30a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204304
Listing Expiration 2026-12-31
Marketing Start 2024-04-24

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 687888433
Hyphenated Format 68788-8433

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
  • 100 TABLET, FILM COATED in 1 BOTTLE (68788-8433-1)
  • 30 TABLET, FILM COATED in 1 BOTTLE (68788-8433-3)
  • 60 TABLET, FILM COATED in 1 BOTTLE (68788-8433-6)
  • 90 TABLET, FILM COATED in 1 BOTTLE (68788-8433-9)
source: ndc

Packages (4)

68788-8433-1 100 TABLET, FILM COATED in 1 BOTTLE (68788-8433-1) 68788-8433-3 30 TABLET, FILM COATED in 1 BOTTLE (68788-8433-3) 68788-8433-6 60 TABLET, FILM COATED in 1 BOTTLE (68788-8433-6) 68788-8433-9 90 TABLET, FILM COATED in 1 BOTTLE (68788-8433-9)

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": "5d4b1d8d-6e91-42aa-bc00-454a8cf4d30a", "openfda": {"nui": ["N0000175836", "N0000000126"], "unii": ["57GNO57U7G"], "rxcui": ["310346"], "spl_set_id": ["33295dce-1e81-4187-bce1-d9b332ea062e"], "pharm_class_epc": ["5-alpha Reductase Inhibitor [EPC]"], "pharm_class_moa": ["5-alpha Reductase Inhibitors [MoA]"], "manufacturer_name": ["Preferred Pharmaceuticals Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (68788-8433-1)", "package_ndc": "68788-8433-1", "marketing_start_date": "20240424"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (68788-8433-3)", "package_ndc": "68788-8433-3", "marketing_start_date": "20240424"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (68788-8433-6)", "package_ndc": "68788-8433-6", "marketing_start_date": "20240424"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (68788-8433-9)", "package_ndc": "68788-8433-9", "marketing_start_date": "20240424"}], "brand_name": "Finasteride", "product_id": "68788-8433_5d4b1d8d-6e91-42aa-bc00-454a8cf4d30a", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["5-alpha Reductase Inhibitor [EPC]", "5-alpha Reductase Inhibitors [MoA]"], "product_ndc": "68788-8433", "generic_name": "Finasteride", "labeler_name": "Preferred Pharmaceuticals Inc.", "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": "20240424", "listing_expiration_date": "20261231"}