finasteride

Generic: finasteride

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

Drug Facts

Product Profile

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

finasteride 5 mg/1

Manufacturer
Camber Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 31722-525
Product ID 31722-525_2c74278f-8221-8804-e063-6394a90a7eaf
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090061
Listing Expiration 2026-12-31
Marketing Start 2015-06-13

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 31722525
Hyphenated Format 31722-525

Supplemental Identifiers

RxCUI
310346
UPC
0331722525305 0331722525909 0331722525107
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 ANDA090061 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (31722-525-01)
  • 500 TABLET, FILM COATED in 1 BOTTLE (31722-525-05)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (31722-525-10)
  • 12 BOTTLE in 1 CASE (31722-525-30) / 30 TABLET, FILM COATED in 1 BOTTLE
  • 12 BOTTLE in 1 CASE (31722-525-90) / 90 TABLET, FILM COATED in 1 BOTTLE
source: ndc

Packages (5)

31722-525-01 100 TABLET, FILM COATED in 1 BOTTLE (31722-525-01) 31722-525-05 500 TABLET, FILM COATED in 1 BOTTLE (31722-525-05) 31722-525-10 1000 TABLET, FILM COATED in 1 BOTTLE (31722-525-10) 31722-525-30 12 BOTTLE in 1 CASE (31722-525-30) / 30 TABLET, FILM COATED in 1 BOTTLE 31722-525-90 12 BOTTLE in 1 CASE (31722-525-90) / 90 TABLET, FILM COATED in 1 BOTTLE

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": "2c74278f-8221-8804-e063-6394a90a7eaf", "openfda": {"nui": ["N0000175836", "N0000000126"], "upc": ["0331722525305", "0331722525909", "0331722525107"], "unii": ["57GNO57U7G"], "rxcui": ["310346"], "spl_set_id": ["cc9709ce-2d29-48bd-b46b-3f72114f2527"], "pharm_class_epc": ["5-alpha Reductase Inhibitor [EPC]"], "pharm_class_moa": ["5-alpha Reductase Inhibitors [MoA]"], "manufacturer_name": ["Camber Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (31722-525-01)", "package_ndc": "31722-525-01", "marketing_start_date": "20150613"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (31722-525-05)", "package_ndc": "31722-525-05", "marketing_start_date": "20150613"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (31722-525-10)", "package_ndc": "31722-525-10", "marketing_start_date": "20150613"}, {"sample": false, "description": "12 BOTTLE in 1 CASE (31722-525-30)  / 30 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "31722-525-30", "marketing_start_date": "20150613"}, {"sample": false, "description": "12 BOTTLE in 1 CASE (31722-525-90)  / 90 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "31722-525-90", "marketing_start_date": "20150613"}], "brand_name": "Finasteride", "product_id": "31722-525_2c74278f-8221-8804-e063-6394a90a7eaf", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["5-alpha Reductase Inhibitor [EPC]", "5-alpha Reductase Inhibitors [MoA]"], "product_ndc": "31722-525", "generic_name": "Finasteride", "labeler_name": "Camber Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Finasteride", "active_ingredients": [{"name": "FINASTERIDE", "strength": "5 mg/1"}], "application_number": "ANDA090061", "marketing_category": "ANDA", "marketing_start_date": "20150613", "listing_expiration_date": "20261231"}