finasteride

Generic: finasteride

Labeler: dr reddys laboratories inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name finasteride
Generic Name finasteride
Labeler dr reddys laboratories inc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

finasteride 5 mg/1

Manufacturer
Dr Reddys Laboratories Inc

Identifiers & Regulatory

Product NDC 43598-303
Product ID 43598-303_8e1e332b-310c-a528-339a-702c542d14dd
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090061
Listing Expiration 2026-12-31
Marketing Start 2012-10-25

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 43598303
Hyphenated Format 43598-303

Supplemental Identifiers

RxCUI
310346
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 ANDA090061 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (43598-303-30)
  • 90 TABLET, FILM COATED in 1 BOTTLE (43598-303-90)
source: ndc

Packages (2)

43598-303-30 30 TABLET, FILM COATED in 1 BOTTLE (43598-303-30) 43598-303-90 90 TABLET, FILM COATED in 1 BOTTLE (43598-303-90)

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": "8e1e332b-310c-a528-339a-702c542d14dd", "openfda": {"nui": ["N0000175836", "N0000000126"], "unii": ["57GNO57U7G"], "rxcui": ["310346"], "spl_set_id": ["c8ed59a3-c5b2-3156-b781-5e514b79011b"], "pharm_class_epc": ["5-alpha Reductase Inhibitor [EPC]"], "pharm_class_moa": ["5-alpha Reductase Inhibitors [MoA]"], "manufacturer_name": ["Dr Reddys Laboratories Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (43598-303-30)", "package_ndc": "43598-303-30", "marketing_start_date": "20121025"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (43598-303-90)", "package_ndc": "43598-303-90", "marketing_start_date": "20121025"}], "brand_name": "Finasteride", "product_id": "43598-303_8e1e332b-310c-a528-339a-702c542d14dd", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["5-alpha Reductase Inhibitor [EPC]", "5-alpha Reductase Inhibitors [MoA]"], "product_ndc": "43598-303", "generic_name": "Finasteride", "labeler_name": "Dr Reddys Laboratories Inc", "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": "20121025", "listing_expiration_date": "20261231"}