Quick answers
- What is Finasteride used for?
- The FDA-approved label (Proscar, Organon LLC, March 18, 2026) says: “PROSCAR, is a 5α-reductase inhibitor, indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to: Improve symptoms Reduce the risk of acute urinary retention Reduce the risk of the need for surgery including transurethral resection of the prostate (TURP) and prostatectomy. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Finasteride have a boxed warning?
- No. None of the 67 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Finasteride?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Finasteride been recalled?
- FDA enforcement reports list 3 recalls of products of this medicine; the newest started February 7, 2023 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Finasteride?
- 29 companies list prescription products of Finasteride in the FDA NDC Directory, including NuCare Pharmaceuticals, Inc., A-S Medication Solutions and Remedyrepack Inc..
What Finasteride is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
PROSCAR, is a 5α-reductase inhibitor, indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to: Improve symptoms Reduce the risk of acute urinary retention Reduce the risk of the need for surgery including transurethral resection of the prostate (TURP) and prostatectomy. …
— FDA label: Proscar, Organon LLC, effective March 18, 2026. Read the full label on DailyMed →
The FDA has 67 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 67 FDA labels for this medicine have a boxed warning.
Forms and how it is given
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| finasteride 1 mg tablet, coated | Generic | $0.0435 per tablet |
| finasteride 1 mg tablet, film coated | Generic | $0.0435 per tablet |
| finasteride 1 mg tablet, film coated | Brand: Propecia | $3.59–$3.97 per tablet 2 packages, lowest to highest |
| finasteride 5 mg tablet | Generic | $0.0686 per tablet |
| finasteride 5 mg tablet, film coated | Generic | $0.0686 per tablet |
| finasteride 5 mg tablet, film coated | Brand: Proscar | $5.70 per tablet |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- NuCare Pharmaceuticals, Inc.10 products
- A-S Medication Solutions7 products
- Remedyrepack Inc.6 products
- Bryant Ranch Prepack6 products
- Preferred Pharmaceuticals Inc.5 products
- Proficient Rx LP4 products
- Asclemed USA, Inc.3 products
- Accord Healthcare Inc.2 products
- Ascend Laboratories, LLC2 products
- Aphena Pharma Solutions - Tennessee, LLC2 products
- Organon LLC2 products
- Aurobindo Pharma Limited2 products
- Cardinal Health 107, LLC2 products
- Rising Pharma Holdings, Inc.2 products
- Camber Pharmaceuticals, Inc.2 products
- Dr. Reddy's Laboratories Limited2 products
- Burel Pharmaceuticals, LLC1 product
- Sun Pharmaceutical Industries, Inc.1 product
- Major Pharmaceuticals1 product
- AvPAK1 product
- American Health Packaging1 product
- Coupler LLC1 product
- Quallent Pharmaceuticals Health LLC1 product
- Atlantic Biologicals Corps1 product
- Direct_Rx1 product
- Thirty Madison Inc1 product
- NCS HealthCare of KY, LLC dba Vangard Labs1 product
- Legacy Pharmaceutical Packaging, LLC1 product
- Exelan Pharmaceuticals Inc.1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA020180 PROSCAR | Organon | June 19, 1992 | 40, latest March 18, 2026 2026: Labeling · 2021: Labeling · 2021: Labeling |
| NDA020788 PROPECIA | Organon | December 19, 1997 | 23, latest August 1, 2022 2022: Labeling · 2021: Labeling · 2016: Manufacturing (CMC) |
Generic approvals (11)
- ANDA076436DR Reddys Labs Inc · July 28, 2006
- ANDA076437DR Reddys Labs Ltd · February 28, 2007
- ANDA078341Aurobindo Pharma · October 30, 2007
- ANDA090121Accord Hlthcare · February 23, 2010
- ANDA090061Hetero Labs Ltd III · June 7, 2010
- ANDA090060Hetero Labs Ltd III · July 1, 2013
- ANDA090508Sun Pharm · July 1, 2013
- ANDA091643Accord Hlthcare · November 5, 2013
- ANDA203687Aurobindo Pharma Ltd · November 5, 2013
- ANDA204304Alkem Labs Ltd · January 5, 2017
- ANDA207750Alkem Labs Ltd · January 6, 2017
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
February 7, 2023 · Class II · Terminated · D-0390-2023
CGMP Deviations: recalling drug products following an FDA inspection.
Finasteride Tablets USP, 1 mg, Rx Only, Packaged as: a) 30-count bottle NDC 16729-089-10 UPC 3 16729 08910 4; b) 90-count bottle NDC 16729-089-15 UPC 3 16729 08915 9; Manufactured for: Accord Healthcare, Inc., Durham, NC — Accord Healthcare, Inc.
-
February 7, 2023 · Class II · Terminated · D-0392-2023
CGMP Deviations: recalling drug products following an FDA inspection.
Finasteride Tablets USP, 5 mg, Rx Only, Packaged as: a) 30-count bottles NDC 16729-090-10 UPC 3 16729 09010 0; b) 90-count bottles NDC 16729-090-15 UPC 3 16729 09015 5; c) 100-count bottles NDC 16729-090-01 UPC 3 16729 0 — Accord Healthcare, Inc.
-
December 29, 2016 · Class III · Terminated · D-0453-2017
Failed Tablet/Capsule Specification: Tablets were found to be twice the thickness in one lot of product.
Finasteride Tablets, USP 5 mg, 90-count bottles, Rx only, Manufactured for : Camber Pharmaceuticals, Inc. Piscataway, NJ 08854 By: Hetero Hetero Labs, Unit V Polepally, Jadcheria, Mahaboob Nagar - 509 301, India Limited — Hetero Drugs Ltd. - Unit 1
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
| RxCUI (RxNorm) | 200172, 201961, 213178, 310346 |
|---|---|
| SPL set ID of the quoted label | 6f988153-fc74-4ca4-b29a-111f750c4a4b |
| FDA labels (SPL) | 67 |
| FDA applications | NDA020180, NDA020788, 11 ANDA |
| Active ingredients (FDA) | FINASTERIDE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Proscar, Organon LLC, effective March 18, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →