finasteride

Generic: finasteride

Labeler: avpak
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name finasteride
Generic Name finasteride
Labeler avpak
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

finasteride 5 mg/1

Manufacturer
AvPAK

Identifiers & Regulatory

Product NDC 50268-314
Product ID 50268-314_47e3617a-bbfd-d911-e063-6294a90ace48
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090061
Listing Expiration 2027-12-31
Marketing Start 2019-01-23

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 50268314
Hyphenated Format 50268-314

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 ANDA090061 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 50 BLISTER PACK in 1 BOX (50268-314-15) / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-314-11)
source: ndc

Packages (1)

50268-314-15 50 BLISTER PACK in 1 BOX (50268-314-15) / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-314-11)

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": "47e3617a-bbfd-d911-e063-6294a90ace48", "openfda": {"nui": ["N0000175836", "N0000000126"], "unii": ["57GNO57U7G"], "rxcui": ["310346"], "spl_set_id": ["800fa54c-c008-ba1e-e053-2a91aa0a2b07"], "pharm_class_epc": ["5-alpha Reductase Inhibitor [EPC]"], "pharm_class_moa": ["5-alpha Reductase Inhibitors [MoA]"], "manufacturer_name": ["AvPAK"]}, "finished": true, "packaging": [{"sample": false, "description": "50 BLISTER PACK in 1 BOX (50268-314-15)  / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-314-11)", "package_ndc": "50268-314-15", "marketing_start_date": "20190123"}], "brand_name": "Finasteride", "product_id": "50268-314_47e3617a-bbfd-d911-e063-6294a90ace48", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["5-alpha Reductase Inhibitor [EPC]", "5-alpha Reductase Inhibitors [MoA]"], "product_ndc": "50268-314", "generic_name": "Finasteride", "labeler_name": "AvPAK", "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": "20190123", "listing_expiration_date": "20271231"}