finasteride

Generic: finasteride

Labeler: american health packaging
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name finasteride
Generic Name finasteride
Labeler american health packaging
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

finasteride 5 mg/1

Manufacturer
American Health Packaging

Identifiers & Regulatory

Product NDC 60687-428
Product ID 60687-428_226ae10d-9842-933e-e063-6394a90a40e5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078341
Listing Expiration 2026-12-31
Marketing Start 2019-09-09

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 60687428
Hyphenated Format 60687-428

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 ANDA078341 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-428-01) / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-428-11)
  • 50 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-428-65) / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-428-11)
source: ndc

Packages (2)

60687-428-01 100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-428-01) / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-428-11) 60687-428-65 50 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-428-65) / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-428-11)

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": "226ae10d-9842-933e-e063-6394a90a40e5", "openfda": {"nui": ["N0000175836", "N0000000126"], "unii": ["57GNO57U7G"], "rxcui": ["310346"], "spl_set_id": ["8f468081-254a-4f11-9f0b-c0311e353a50"], "pharm_class_epc": ["5-alpha Reductase Inhibitor [EPC]"], "pharm_class_moa": ["5-alpha Reductase Inhibitors [MoA]"], "manufacturer_name": ["American Health Packaging"]}, "finished": true, "packaging": [{"sample": false, "description": "100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-428-01)  / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-428-11)", "package_ndc": "60687-428-01", "marketing_start_date": "20190909"}, {"sample": false, "description": "50 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-428-65)  / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-428-11)", "package_ndc": "60687-428-65", "marketing_start_date": "20200120"}], "brand_name": "Finasteride", "product_id": "60687-428_226ae10d-9842-933e-e063-6394a90a40e5", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["5-alpha Reductase Inhibitor [EPC]", "5-alpha Reductase Inhibitors [MoA]"], "product_ndc": "60687-428", "generic_name": "Finasteride", "labeler_name": "American Health Packaging", "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": "20190909", "listing_expiration_date": "20261231"}