finasteride

Generic: finasteride

Labeler: burel pharmaceuticals, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

finasteride 1 mg/1

Manufacturer
Burel Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 35573-400
Product ID 35573-400_6752dcb1-091e-40a9-a6e2-069d543398a7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203687
Listing Expiration 2026-12-31
Marketing Start 2018-07-13

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 35573400
Hyphenated Format 35573-400

Supplemental Identifiers

RxCUI
200172
UPC
0335573400996
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 ANDA203687 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/1
source: ndc
Packaging
  • 1000 TABLET, FILM COATED in 1 BOTTLE (35573-400-99)
source: ndc

Packages (1)

35573-400-99 1000 TABLET, FILM COATED in 1 BOTTLE (35573-400-99)

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": "6752dcb1-091e-40a9-a6e2-069d543398a7", "openfda": {"nui": ["N0000175836", "N0000000126"], "upc": ["0335573400996"], "unii": ["57GNO57U7G"], "rxcui": ["200172"], "spl_set_id": ["c8516eaa-98d0-4eb1-bc65-aa765baea5db"], "pharm_class_epc": ["5-alpha Reductase Inhibitor [EPC]"], "pharm_class_moa": ["5-alpha Reductase Inhibitors [MoA]"], "manufacturer_name": ["Burel Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (35573-400-99)", "package_ndc": "35573-400-99", "marketing_start_date": "20180713"}], "brand_name": "Finasteride", "product_id": "35573-400_6752dcb1-091e-40a9-a6e2-069d543398a7", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["5-alpha Reductase Inhibitor [EPC]", "5-alpha Reductase Inhibitors [MoA]"], "product_ndc": "35573-400", "generic_name": "Finasteride", "labeler_name": "Burel Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Finasteride", "active_ingredients": [{"name": "FINASTERIDE", "strength": "1 mg/1"}], "application_number": "ANDA203687", "marketing_category": "ANDA", "marketing_start_date": "20180713", "listing_expiration_date": "20261231"}