finasteride

Generic: finasteride

Labeler: cardinal health 107, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name finasteride
Generic Name finasteride
Labeler cardinal health 107, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

finasteride 5 mg/1

Manufacturer
Cardinal Health 107, LLC

Identifiers & Regulatory

Product NDC 55154-8083
Product ID 55154-8083_b44dc9c3-d0a3-4d44-a760-9f1d397567ab
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090061
Listing Expiration 2027-12-31
Marketing Start 2015-06-13

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 551548083
Hyphenated Format 55154-8083

Supplemental Identifiers

RxCUI
310346
UPC
0055154808309
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
  • 10 BLISTER PACK in 1 BAG (55154-8083-0) / 1 TABLET, FILM COATED in 1 BLISTER PACK
source: ndc

Packages (1)

55154-8083-0 10 BLISTER PACK in 1 BAG (55154-8083-0) / 1 TABLET, FILM COATED in 1 BLISTER PACK

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": "b44dc9c3-d0a3-4d44-a760-9f1d397567ab", "openfda": {"nui": ["N0000175836", "N0000000126"], "upc": ["0055154808309"], "unii": ["57GNO57U7G"], "rxcui": ["310346"], "spl_set_id": ["3fec2bcb-91b8-4041-9ee8-e5a4ebe5fd04"], "pharm_class_epc": ["5-alpha Reductase Inhibitor [EPC]"], "pharm_class_moa": ["5-alpha Reductase Inhibitors [MoA]"], "manufacturer_name": ["Cardinal Health 107, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "10 BLISTER PACK in 1 BAG (55154-8083-0)  / 1 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "55154-8083-0", "marketing_start_date": "20150613"}], "brand_name": "Finasteride", "product_id": "55154-8083_b44dc9c3-d0a3-4d44-a760-9f1d397567ab", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["5-alpha Reductase Inhibitor [EPC]", "5-alpha Reductase Inhibitors [MoA]"], "product_ndc": "55154-8083", "generic_name": "Finasteride", "labeler_name": "Cardinal Health 107, LLC", "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": "20150613", "listing_expiration_date": "20271231"}