finasteride

Generic: finasteride

Labeler: nucare pharmaceuticals,inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

finasteride 5 mg/1

Manufacturer
NuCare Pharmaceuticals,Inc.

Identifiers & Regulatory

Product NDC 68071-3380
Product ID 68071-3380_1ce945ae-76ae-0366-e063-6294a90ab575
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090121
Listing Expiration 2026-12-31
Marketing Start 2010-05-28

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 680713380
Hyphenated Format 68071-3380

Supplemental Identifiers

RxCUI
310346
UPC
0368071338034
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 ANDA090121 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (68071-3380-3)
source: ndc

Packages (1)

68071-3380-3 30 TABLET, FILM COATED in 1 BOTTLE (68071-3380-3)

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": "1ce945ae-76ae-0366-e063-6294a90ab575", "openfda": {"nui": ["N0000175836", "N0000000126"], "upc": ["0368071338034"], "unii": ["57GNO57U7G"], "rxcui": ["310346"], "spl_set_id": ["549aab5d-819a-1691-e054-00144ff88e88"], "pharm_class_epc": ["5-alpha Reductase Inhibitor [EPC]"], "pharm_class_moa": ["5-alpha Reductase Inhibitors [MoA]"], "manufacturer_name": ["NuCare Pharmaceuticals,Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (68071-3380-3)", "package_ndc": "68071-3380-3", "marketing_start_date": "20170718"}], "brand_name": "Finasteride", "product_id": "68071-3380_1ce945ae-76ae-0366-e063-6294a90ab575", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["5-alpha Reductase Inhibitor [EPC]", "5-alpha Reductase Inhibitors [MoA]"], "product_ndc": "68071-3380", "generic_name": "finasteride", "labeler_name": "NuCare Pharmaceuticals,Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Finasteride", "active_ingredients": [{"name": "FINASTERIDE", "strength": "5 mg/1"}], "application_number": "ANDA090121", "marketing_category": "ANDA", "marketing_start_date": "20100528", "listing_expiration_date": "20261231"}