finasteride

Generic: finasteride

Labeler: asclemed usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

finasteride 1 mg/1

Manufacturer
Asclemed USA, Inc.

Identifiers & Regulatory

Product NDC 76420-074
Product ID 76420-074_ead2d1fe-f89c-ee3a-e053-2995a90ac920
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090060
Listing Expiration 2026-12-31
Marketing Start 2013-07-01

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 76420074
Hyphenated Format 76420-074

Supplemental Identifiers

RxCUI
200172
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 ANDA090060 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (76420-074-30)
source: ndc

Packages (1)

76420-074-30 30 TABLET, FILM COATED in 1 BOTTLE (76420-074-30)

Ingredients (1)

finasteride (1 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": "ead2d1fe-f89c-ee3a-e053-2995a90ac920", "openfda": {"nui": ["N0000175836", "N0000000126"], "unii": ["57GNO57U7G"], "rxcui": ["200172"], "spl_set_id": ["b63af2cd-5c12-4977-bac4-95e1eae11e57"], "pharm_class_epc": ["5-alpha Reductase Inhibitor [EPC]"], "pharm_class_moa": ["5-alpha Reductase Inhibitors [MoA]"], "manufacturer_name": ["Asclemed USA, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (76420-074-30)", "package_ndc": "76420-074-30", "marketing_start_date": "20200104"}], "brand_name": "Finasteride", "product_id": "76420-074_ead2d1fe-f89c-ee3a-e053-2995a90ac920", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["5-alpha Reductase Inhibitor [EPC]", "5-alpha Reductase Inhibitors [MoA]"], "product_ndc": "76420-074", "generic_name": "Finasteride", "labeler_name": "Asclemed USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Finasteride", "active_ingredients": [{"name": "FINASTERIDE", "strength": "1 mg/1"}], "application_number": "ANDA090060", "marketing_category": "ANDA", "marketing_start_date": "20130701", "listing_expiration_date": "20261231"}