finasteride

Generic: finasteride

Labeler: legacy pharmaceutical packaging, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name finasteride
Generic Name finasteride
Labeler legacy pharmaceutical packaging, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

finasteride 5 mg/1

Manufacturer
Legacy Pharmaceutical Packaging, LLC

Identifiers & Regulatory

Product NDC 68645-541
Product ID 68645-541_4c221995-67cb-49dd-e063-6294a90a2aef
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090061
Listing Expiration 2027-12-31
Marketing Start 2015-06-13

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 68645541
Hyphenated Format 68645-541

Supplemental Identifiers

RxCUI
310346
UPC
0368645541549
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 ANDA090061 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (68645-541-54)
source: ndc

Packages (1)

68645-541-54 30 TABLET, FILM COATED in 1 BOTTLE (68645-541-54)

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": "4c221995-67cb-49dd-e063-6294a90a2aef", "openfda": {"nui": ["N0000175836", "N0000000126"], "upc": ["0368645541549"], "unii": ["57GNO57U7G"], "rxcui": ["310346"], "spl_set_id": ["a3b49681-09b3-4c26-bb57-3dfd598d48b6"], "pharm_class_epc": ["5-alpha Reductase Inhibitor [EPC]"], "pharm_class_moa": ["5-alpha Reductase Inhibitors [MoA]"], "manufacturer_name": ["Legacy Pharmaceutical Packaging, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (68645-541-54)", "package_ndc": "68645-541-54", "marketing_start_date": "20150613"}], "brand_name": "Finasteride", "product_id": "68645-541_4c221995-67cb-49dd-e063-6294a90a2aef", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["5-alpha Reductase Inhibitor [EPC]", "5-alpha Reductase Inhibitors [MoA]"], "product_ndc": "68645-541", "generic_name": "Finasteride", "labeler_name": "Legacy Pharmaceutical Packaging, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Finasteride", "active_ingredients": [{"name": "FINASTERIDE", "strength": "5 mg/1"}], "application_number": "ANDA090061", "marketing_category": "ANDA", "marketing_start_date": "20150613", "listing_expiration_date": "20271231"}