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 70518-3616
Product ID 70518-3616_4341dc83-945a-c779-e063-6394a90a9fe8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078341
Listing Expiration 2026-12-31
Marketing Start 2023-01-18

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 705183616
Hyphenated Format 70518-3616

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 ANDA078341 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 30 POUCH in 1 BOX (70518-3616-1) / 1 TABLET, FILM COATED in 1 POUCH (70518-3616-2)
  • 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-3616-3)
  • 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3616-4)
  • 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3616-5)
source: ndc

Packages (4)

70518-3616-1 30 POUCH in 1 BOX (70518-3616-1) / 1 TABLET, FILM COATED in 1 POUCH (70518-3616-2) 70518-3616-3 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-3616-3) 70518-3616-4 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3616-4) 70518-3616-5 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3616-5)

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": "4341dc83-945a-c779-e063-6394a90a9fe8", "openfda": {"nui": ["N0000175836", "N0000000126"], "unii": ["57GNO57U7G"], "rxcui": ["310346"], "spl_set_id": ["e482a50d-db15-4407-85c9-160c88e8a657"], "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 (70518-3616-1)  / 1 TABLET, FILM COATED in 1 POUCH (70518-3616-2)", "package_ndc": "70518-3616-1", "marketing_start_date": "20230210"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BLISTER PACK (70518-3616-3)", "package_ndc": "70518-3616-3", "marketing_start_date": "20230510"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3616-4)", "package_ndc": "70518-3616-4", "marketing_start_date": "20240125"}, {"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3616-5)", "package_ndc": "70518-3616-5", "marketing_start_date": "20240807"}], "brand_name": "Finasteride", "product_id": "70518-3616_4341dc83-945a-c779-e063-6394a90a9fe8", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["5-alpha Reductase Inhibitor [EPC]", "5-alpha Reductase Inhibitors [MoA]"], "product_ndc": "70518-3616", "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": "ANDA078341", "marketing_category": "ANDA", "marketing_start_date": "20230118", "listing_expiration_date": "20261231"}