finasteride

Generic: finasteride

Labeler: sun pharmaceutical industries, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name finasteride
Generic Name finasteride
Labeler sun pharmaceutical industries, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

finasteride 1 mg/1

Manufacturer
Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 47335-714
Product ID 47335-714_3fb7fc89-95b5-4c8a-9b1c-dd509cadb4eb
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090508
Listing Expiration 2026-12-31
Marketing Start 2022-11-23

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 47335714
Hyphenated Format 47335-714

Supplemental Identifiers

RxCUI
200172
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 ANDA090508 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (47335-714-08)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (47335-714-18)
  • 90 TABLET, FILM COATED in 1 BOTTLE (47335-714-81)
  • 30 TABLET, FILM COATED in 1 BOTTLE (47335-714-83)
  • 100 TABLET, FILM COATED in 1 BOTTLE (47335-714-88)
source: ndc

Packages (5)

47335-714-08 100 TABLET, FILM COATED in 1 BOTTLE (47335-714-08) 47335-714-18 1000 TABLET, FILM COATED in 1 BOTTLE (47335-714-18) 47335-714-81 90 TABLET, FILM COATED in 1 BOTTLE (47335-714-81) 47335-714-83 30 TABLET, FILM COATED in 1 BOTTLE (47335-714-83) 47335-714-88 100 TABLET, FILM COATED in 1 BOTTLE (47335-714-88)

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": "3fb7fc89-95b5-4c8a-9b1c-dd509cadb4eb", "openfda": {"nui": ["N0000175836", "N0000000126"], "unii": ["57GNO57U7G"], "rxcui": ["200172"], "spl_set_id": ["abd87058-923f-4767-986c-278201c0e688"], "pharm_class_epc": ["5-alpha Reductase Inhibitor [EPC]"], "pharm_class_moa": ["5-alpha Reductase Inhibitors [MoA]"], "manufacturer_name": ["Sun Pharmaceutical Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (47335-714-08)", "package_ndc": "47335-714-08", "marketing_start_date": "20221123"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (47335-714-18)", "package_ndc": "47335-714-18", "marketing_start_date": "20221123"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (47335-714-81)", "package_ndc": "47335-714-81", "marketing_start_date": "20221123"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (47335-714-83)", "package_ndc": "47335-714-83", "marketing_start_date": "20221123"}, {"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (47335-714-88)", "package_ndc": "47335-714-88", "marketing_start_date": "20221123"}], "brand_name": "Finasteride", "product_id": "47335-714_3fb7fc89-95b5-4c8a-9b1c-dd509cadb4eb", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["5-alpha Reductase Inhibitor [EPC]", "5-alpha Reductase Inhibitors [MoA]"], "product_ndc": "47335-714", "generic_name": "Finasteride", "labeler_name": "Sun Pharmaceutical Industries, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Finasteride", "active_ingredients": [{"name": "FINASTERIDE", "strength": "1 mg/1"}], "application_number": "ANDA090508", "marketing_category": "ANDA", "marketing_start_date": "20221123", "listing_expiration_date": "20261231"}