finasteride

Generic: finasteride

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

Drug Facts

Product Profile

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

finasteride 5 mg/1

Manufacturer
Exelan Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 76282-412
Product ID 76282-412_6e0d44f6-d0c0-4db5-b0ea-8f52dd2e5613
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090061
Listing Expiration 2026-12-31
Marketing Start 2015-05-22

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 76282412
Hyphenated Format 76282-412

Supplemental Identifiers

RxCUI
310346
UPC
0376282412900
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 ANDA090061 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 500 TABLET, FILM COATED in 1 BOTTLE (76282-412-05)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (76282-412-10)
  • 30 TABLET, FILM COATED in 1 BOTTLE (76282-412-30)
  • 90 TABLET, FILM COATED in 1 BOTTLE (76282-412-90)
source: ndc

Packages (4)

76282-412-05 500 TABLET, FILM COATED in 1 BOTTLE (76282-412-05) 76282-412-10 1000 TABLET, FILM COATED in 1 BOTTLE (76282-412-10) 76282-412-30 30 TABLET, FILM COATED in 1 BOTTLE (76282-412-30) 76282-412-90 90 TABLET, FILM COATED in 1 BOTTLE (76282-412-90)

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": "6e0d44f6-d0c0-4db5-b0ea-8f52dd2e5613", "openfda": {"nui": ["N0000175836", "N0000000126"], "upc": ["0376282412900"], "unii": ["57GNO57U7G"], "rxcui": ["310346"], "spl_set_id": ["1c1bf77c-f99a-44e4-b71e-ce766afa99b6"], "pharm_class_epc": ["5-alpha Reductase Inhibitor [EPC]"], "pharm_class_moa": ["5-alpha Reductase Inhibitors [MoA]"], "manufacturer_name": ["Exelan Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (76282-412-05)", "package_ndc": "76282-412-05", "marketing_start_date": "20150522"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (76282-412-10)", "package_ndc": "76282-412-10", "marketing_start_date": "20150522"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (76282-412-30)", "package_ndc": "76282-412-30", "marketing_start_date": "20150522"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (76282-412-90)", "package_ndc": "76282-412-90", "marketing_start_date": "20150522"}], "brand_name": "Finasteride", "product_id": "76282-412_6e0d44f6-d0c0-4db5-b0ea-8f52dd2e5613", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["5-alpha Reductase Inhibitor [EPC]", "5-alpha Reductase Inhibitors [MoA]"], "product_ndc": "76282-412", "generic_name": "Finasteride", "labeler_name": "Exelan Pharmaceuticals Inc.", "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": "20150522", "listing_expiration_date": "20261231"}