finasteride

Generic: finasteride

Labeler: remedyrepack inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

finasteride 5 mg/1

Manufacturer
REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-3600
Product ID 70518-3600_41e73652-3988-a7c5-e063-6294a90abf09
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204304
Listing Expiration 2026-12-31
Marketing Start 2022-12-28

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 705183600
Hyphenated Format 70518-3600

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 ANDA204304 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 30 POUCH in 1 BOX (70518-3600-1) / 1 TABLET, FILM COATED in 1 POUCH (70518-3600-0)
  • 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-3600-3)
source: ndc

Packages (2)

70518-3600-1 30 POUCH in 1 BOX (70518-3600-1) / 1 TABLET, FILM COATED in 1 POUCH (70518-3600-0) 70518-3600-3 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-3600-3)

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": "41e73652-3988-a7c5-e063-6294a90abf09", "openfda": {"nui": ["N0000175836", "N0000000126"], "unii": ["57GNO57U7G"], "rxcui": ["310346"], "spl_set_id": ["aa3fcd1a-02a1-49db-b40e-75e623d730e1"], "pharm_class_epc": ["5-alpha Reductase Inhibitor [EPC]"], "pharm_class_moa": ["5-alpha Reductase Inhibitors [MoA]"], "manufacturer_name": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "30 POUCH in 1 BOX (70518-3600-1)  / 1 TABLET, FILM COATED in 1 POUCH (70518-3600-0)", "package_ndc": "70518-3600-1", "marketing_start_date": "20221228"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BLISTER PACK (70518-3600-3)", "package_ndc": "70518-3600-3", "marketing_start_date": "20230501"}], "brand_name": "Finasteride", "product_id": "70518-3600_41e73652-3988-a7c5-e063-6294a90abf09", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["5-alpha Reductase Inhibitor [EPC]", "5-alpha Reductase Inhibitors [MoA]"], "product_ndc": "70518-3600", "generic_name": "Finasteride", "labeler_name": "REMEDYREPACK INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Finasteride", "active_ingredients": [{"name": "FINASTERIDE", "strength": "5 mg/1"}], "application_number": "ANDA204304", "marketing_category": "ANDA", "marketing_start_date": "20221228", "listing_expiration_date": "20261231"}