finasteride

Generic: finasteride

Labeler: ascend laboratories, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name finasteride
Generic Name finasteride
Labeler ascend laboratories, llc
Dosage Form TABLET, COATED
Routes
ORAL
Active Ingredients

finasteride 1 mg/1

Manufacturer
Ascend Laboratories, LLC

Identifiers & Regulatory

Product NDC 67877-455
Product ID 67877-455_f4ed6589-2062-48b0-8a0c-25b0342342c2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207750
Listing Expiration 2026-12-31
Marketing Start 2017-01-06

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 67877455
Hyphenated Format 67877-455

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 ANDA207750 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/1
source: ndc
Packaging
  • 500 TABLET, COATED in 1 BOTTLE (67877-455-05)
  • 30 TABLET, COATED in 1 BOTTLE (67877-455-30)
  • 90 TABLET, COATED in 1 BOTTLE (67877-455-90)
  • 3 BLISTER PACK in 1 CARTON (67877-455-94) / 10 TABLET, COATED in 1 BLISTER PACK (67877-455-34)
source: ndc

Packages (4)

67877-455-05 500 TABLET, COATED in 1 BOTTLE (67877-455-05) 67877-455-30 30 TABLET, COATED in 1 BOTTLE (67877-455-30) 67877-455-90 90 TABLET, COATED in 1 BOTTLE (67877-455-90) 67877-455-94 3 BLISTER PACK in 1 CARTON (67877-455-94) / 10 TABLET, COATED in 1 BLISTER PACK (67877-455-34)

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": "f4ed6589-2062-48b0-8a0c-25b0342342c2", "openfda": {"nui": ["N0000175836", "N0000000126"], "unii": ["57GNO57U7G"], "rxcui": ["200172"], "spl_set_id": ["ecd2fbb2-a4bd-44f2-831d-179e7dbf0741"], "pharm_class_epc": ["5-alpha Reductase Inhibitor [EPC]"], "pharm_class_moa": ["5-alpha Reductase Inhibitors [MoA]"], "manufacturer_name": ["Ascend Laboratories, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET, COATED in 1 BOTTLE (67877-455-05)", "package_ndc": "67877-455-05", "marketing_start_date": "20250131"}, {"sample": false, "description": "30 TABLET, COATED in 1 BOTTLE (67877-455-30)", "package_ndc": "67877-455-30", "marketing_start_date": "20170106"}, {"sample": false, "description": "90 TABLET, COATED in 1 BOTTLE (67877-455-90)", "package_ndc": "67877-455-90", "marketing_start_date": "20170106"}, {"sample": false, "description": "3 BLISTER PACK in 1 CARTON (67877-455-94)  / 10 TABLET, COATED in 1 BLISTER PACK (67877-455-34)", "package_ndc": "67877-455-94", "marketing_start_date": "20170106"}], "brand_name": "Finasteride", "product_id": "67877-455_f4ed6589-2062-48b0-8a0c-25b0342342c2", "dosage_form": "TABLET, COATED", "pharm_class": ["5-alpha Reductase Inhibitor [EPC]", "5-alpha Reductase Inhibitors [MoA]"], "product_ndc": "67877-455", "generic_name": "Finasteride", "labeler_name": "Ascend Laboratories, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Finasteride", "active_ingredients": [{"name": "FINASTERIDE", "strength": "1 mg/1"}], "application_number": "ANDA207750", "marketing_category": "ANDA", "marketing_start_date": "20170106", "listing_expiration_date": "20261231"}