proscar

Generic: finasteride

Labeler: organon llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name proscar
Generic Name finasteride
Labeler organon llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

finasteride 5 mg/1

Manufacturer
Organon LLC

Identifiers & Regulatory

Product NDC 78206-153
Product ID 78206-153_8133d268-29d6-431d-bc20-8d01c8b8459a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA020180
Listing Expiration 2026-12-31
Marketing Start 2021-06-01

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 78206153
Hyphenated Format 78206-153

Supplemental Identifiers

RxCUI
201961 310346
UPC
0378206153012
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 proscar (source: ndc)
Generic Name finasteride (source: ndc)
Application Number NDA020180 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (78206-153-01)
  • 100 TABLET, FILM COATED in 1 BOTTLE (78206-153-02)
source: ndc

Packages (2)

78206-153-01 30 TABLET, FILM COATED in 1 BOTTLE (78206-153-01) 78206-153-02 100 TABLET, FILM COATED in 1 BOTTLE (78206-153-02)

Ingredients (1)

finasteride (5 mg/1)

Linked Drug Pages (1)

PROSCAR ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "8133d268-29d6-431d-bc20-8d01c8b8459a", "openfda": {"nui": ["N0000175836", "N0000000126"], "upc": ["0378206153012"], "unii": ["57GNO57U7G"], "rxcui": ["201961", "310346"], "spl_set_id": ["6f988153-fc74-4ca4-b29a-111f750c4a4b"], "pharm_class_epc": ["5-alpha Reductase Inhibitor [EPC]"], "pharm_class_moa": ["5-alpha Reductase Inhibitors [MoA]"], "manufacturer_name": ["Organon LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (78206-153-01)", "package_ndc": "78206-153-01", "marketing_start_date": "20210601"}, {"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (78206-153-02)", "package_ndc": "78206-153-02", "marketing_start_date": "20210601"}], "brand_name": "PROSCAR", "product_id": "78206-153_8133d268-29d6-431d-bc20-8d01c8b8459a", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["5-alpha Reductase Inhibitor [EPC]", "5-alpha Reductase Inhibitors [MoA]"], "product_ndc": "78206-153", "generic_name": "FINASTERIDE", "labeler_name": "Organon LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "PROSCAR", "active_ingredients": [{"name": "FINASTERIDE", "strength": "5 mg/1"}], "application_number": "NDA020180", "marketing_category": "NDA", "marketing_start_date": "20210601", "listing_expiration_date": "20261231"}