finasteride

Generic: finasteride

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

Drug Facts

Product Profile

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

finasteride 5 mg/1

Manufacturer
Teva Pharmaceuticals USA, Inc.

Identifiers & Regulatory

Product NDC 0093-7355
Product ID 0093-7355_4c152e0f-55b3-4357-b983-897ecaf878af
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076511
Marketing Start 2006-12-15
Marketing End 2026-09-30

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 00937355
Hyphenated Format 0093-7355

Supplemental Identifiers

RxCUI
310346
UPC
0300937355564
UNII
57GNO57U7G
NUI
N0000175836 N0000000126

Packaging Origin

Original Packager
true

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 ANDA076511 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 500 TABLET, FILM COATED in 1 BOTTLE (0093-7355-05)
  • 30 TABLET, FILM COATED in 1 BOTTLE (0093-7355-56)
  • 90 TABLET, FILM COATED in 1 BOTTLE (0093-7355-98)
source: ndc

Packages (3)

0093-7355-05 500 TABLET, FILM COATED in 1 BOTTLE (0093-7355-05) 0093-7355-56 30 TABLET, FILM COATED in 1 BOTTLE (0093-7355-56) 0093-7355-98 90 TABLET, FILM COATED in 1 BOTTLE (0093-7355-98)

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": "4c152e0f-55b3-4357-b983-897ecaf878af", "openfda": {"nui": ["N0000175836", "N0000000126"], "upc": ["0300937355564"], "unii": ["57GNO57U7G"], "rxcui": ["310346"], "spl_set_id": ["77589cc3-c440-4695-800c-82a0e5128a6c"], "pharm_class_epc": ["5-alpha Reductase Inhibitor [EPC]"], "pharm_class_moa": ["5-alpha Reductase Inhibitors [MoA]"], "manufacturer_name": ["Teva Pharmaceuticals USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (0093-7355-05)", "package_ndc": "0093-7355-05", "marketing_end_date": "20260930", "marketing_start_date": "20080314"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (0093-7355-56)", "package_ndc": "0093-7355-56", "marketing_end_date": "20260930", "marketing_start_date": "20061215"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (0093-7355-98)", "package_ndc": "0093-7355-98", "marketing_end_date": "20260930", "marketing_start_date": "20070222"}], "brand_name": "Finasteride", "product_id": "0093-7355_4c152e0f-55b3-4357-b983-897ecaf878af", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["5-alpha Reductase Inhibitor [EPC]", "5-alpha Reductase Inhibitors [MoA]"], "product_ndc": "0093-7355", "generic_name": "Finasteride", "labeler_name": "Teva Pharmaceuticals USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Finasteride", "active_ingredients": [{"name": "FINASTERIDE", "strength": "5 mg/1"}], "application_number": "ANDA076511", "marketing_category": "ANDA", "marketing_end_date": "20260930", "marketing_start_date": "20061215"}