finasteride

Generic: finasteride

Labeler: major pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

finasteride 5 mg/1

Manufacturer
Major Pharmaceuticals

Identifiers & Regulatory

Product NDC 0904-6830
Product ID 0904-6830_d1f34c55-de1d-48a5-af38-06cbea8c6b8d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090061
Listing Expiration 2026-12-31
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 09046830
Hyphenated Format 0904-6830

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 CARTON (0904-6830-06) / 1 TABLET, FILM COATED in 1 BLISTER PACK
  • 100 BLISTER PACK in 1 CARTON (0904-6830-61) / 1 TABLET, FILM COATED in 1 BLISTER PACK
source: ndc

Packages (2)

0904-6830-06 50 BLISTER PACK in 1 CARTON (0904-6830-06) / 1 TABLET, FILM COATED in 1 BLISTER PACK 0904-6830-61 100 BLISTER PACK in 1 CARTON (0904-6830-61) / 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": "d1f34c55-de1d-48a5-af38-06cbea8c6b8d", "openfda": {"nui": ["N0000175836", "N0000000126"], "unii": ["57GNO57U7G"], "rxcui": ["310346"], "spl_set_id": ["3272651f-b500-4d5d-9e29-22fcd8e24fcb"], "pharm_class_epc": ["5-alpha Reductase Inhibitor [EPC]"], "pharm_class_moa": ["5-alpha Reductase Inhibitors [MoA]"], "manufacturer_name": ["Major Pharmaceuticals"]}, "finished": true, "packaging": [{"sample": false, "description": "50 BLISTER PACK in 1 CARTON (0904-6830-06)  / 1 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "0904-6830-06", "marketing_start_date": "20150613"}, {"sample": false, "description": "100 BLISTER PACK in 1 CARTON (0904-6830-61)  / 1 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "0904-6830-61", "marketing_start_date": "20150613"}], "brand_name": "Finasteride", "product_id": "0904-6830_d1f34c55-de1d-48a5-af38-06cbea8c6b8d", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["5-alpha Reductase Inhibitor [EPC]", "5-alpha Reductase Inhibitors [MoA]"], "product_ndc": "0904-6830", "generic_name": "Finasteride", "labeler_name": "Major Pharmaceuticals", "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": "20261231"}