finasteride

Generic: finasteride

Labeler: quallent pharmaceuticals health llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name finasteride
Generic Name finasteride
Labeler quallent pharmaceuticals health llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

finasteride 5 mg/1

Manufacturer
QUALLENT PHARMACEUTICALS HEALTH LLC

Identifiers & Regulatory

Product NDC 82009-061
Product ID 82009-061_7e56c5b9-a7be-4413-83f2-38c0f3c688e3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078341
Listing Expiration 2026-12-31
Marketing Start 2022-11-21

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 82009061
Hyphenated Format 82009-061

Supplemental Identifiers

RxCUI
310346
UPC
0382009061054
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 ANDA078341 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 500 TABLET, FILM COATED in 1 BOTTLE (82009-061-05)
source: ndc

Packages (1)

82009-061-05 500 TABLET, FILM COATED in 1 BOTTLE (82009-061-05)

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": "7e56c5b9-a7be-4413-83f2-38c0f3c688e3", "openfda": {"nui": ["N0000175836", "N0000000126"], "upc": ["0382009061054"], "unii": ["57GNO57U7G"], "rxcui": ["310346"], "spl_set_id": ["5efc695c-d9fd-4892-a63f-a35cceb8d3c7"], "pharm_class_epc": ["5-alpha Reductase Inhibitor [EPC]"], "pharm_class_moa": ["5-alpha Reductase Inhibitors [MoA]"], "manufacturer_name": ["QUALLENT PHARMACEUTICALS HEALTH LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (82009-061-05)", "package_ndc": "82009-061-05", "marketing_start_date": "20221121"}], "brand_name": "Finasteride", "product_id": "82009-061_7e56c5b9-a7be-4413-83f2-38c0f3c688e3", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["5-alpha Reductase Inhibitor [EPC]", "5-alpha Reductase Inhibitors [MoA]"], "product_ndc": "82009-061", "generic_name": "Finasteride", "labeler_name": "QUALLENT PHARMACEUTICALS HEALTH LLC", "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": "20221121", "listing_expiration_date": "20261231"}