Prescription medicine
Finasteride Brand names: Proscar, Propecia
Finasteride (Proscar) is a prescription medicine with an FDA approval on record since 1992. FDA's NDC Directory lists it from 30 generic labelers, and pharmacies paid $0.0688 per finasteride 5 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the finasteride FDA label on DailyMed (effective March 18, 2026, Organon LLC); the NDA 20180 record on Drugs@FDA; every finasteride label on DailyMed.
Highlights of the record
FDA label of March 18, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usagePROSCAR, is a 5α-reductase inhibitor, indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to ( 1.1 ): 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.
Forms and strengths
- 1 mg
- 5 mg
Film-coated tablet; coated tablet; tablet.
On the market
- Earliest approval on file
- June 19, 1992 Proscar, Organon; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 22 first June 19, 2006; 14 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 31 of which 30 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.0688 per tablet Finasteride 5 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 6 since 2013 0 Class I among all firms' recalls; latest March 23, 2023; 1 more by firms not listed as its makers
- FAERS reports
- 59,983 through July 30, 2026
What is finasteride used for?
From the label: indications and usagePROSCAR, is a 5α-reductase inhibitor, indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to ( 1.1 ): 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. PROSCAR administered in combination with the alpha-blocker doxazosin is indicated to reduce the risk of symptomatic progression of BPH (a confirmed ≥4 point increase in American Urological Association (AUA) symptom score) ( 1.2 ). […]
Conditions named in the indications of finasteride's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: 5-alpha Reductase Inhibitor.
Source: FDA drug label (PROSCAR), Organon LLC, effective March 18, 2026 (SPL set 6f988153-fc74-4ca4-b29a-111f750c4a4b), via openFDA; the full label on DailyMed
Is there a generic for finasteride (Proscar)?
The FDA approved the first generic finasteride on June 19, 2006. 22 generic applications are approved; 14 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists finasteride from 30 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1992 earliest approval on file
- 2006 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for finasteride (Proscar)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.0688 per Finasteride 5 mg tablet, down 1% from $0.0696 on October 8, 2025. Prices per unit in the table differ many-fold by strength, form and brand, so compare like with like. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Finasteride 5 mg tablet (generic)
- Propecia 1 mg tablet (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Finasteride 1 mg tablet | Generic | $0.0436 per tablet | $1.31 | -2% |
| Finasteride 5 mg tablet | Generic | $0.0688 per tablet | $2.06 | -1% |
| Propecia 1 mg tablet | Brand | $3.78 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $113.30 | +5% |
| Proscar 5 mg tablet | Brand | $5.70 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $171.05 | +4% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has finasteride been recalled?
The FDA's Enforcement Report lists 7 recalls naming finasteride since 2013: 0 Class I (the most serious), 6 Class II, 1 Class III; 1 still ongoing. 1 of them is by a firm that FDA's NDC Directory does not list as a maker of finasteride and that holds no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| March 23, 2023 | Class II | Preferred Pharmaceuticals, Inc. | cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. |
| March 13, 2023 | Class II | Direct Rx | cGMP deviations |
| February 7, 2023 | Class II | Accord Healthcare, Inc. | CGMP Deviations: recalling drug products following an FDA inspection. |
| December 29, 2016 | Class III | Hetero Drugs Ltd. - Unit 1 | Failed Tablet/Capsule Specification: Tablets were found to be twice the thickness in one lot of product. |
| July 2, 2013 | Class II | Aidapak Services, LLC not a listed maker | Labeling: Label Mixup; FINASTERIDE, Tablet, 5 mg may be potentially mislabeled as DIGOXIN, Tablet, 0.125 mg, NDC 00115981101, Pedigree: AD62829_8, EXP … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the finasteride label say about other medicines?
The finasteride label names 7 other medicines in its interaction, contraindication or warning sections. The labels of 3 other medicines name finasteride. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Acetaminophen | drug interactions | Although specific interaction studies were not performed, PROSCAR was concomitantly used in clinical studies with acetaminophen, acetylsalicylic acid, α-blockers, angiotensin-converting enzyme (ACE) inhibitors, analgesics, anti-convulsants, beta-adrenergic blocking agents, diuretics, calcium channel blockers, cardiac … |
| Digoxin | drug interactions | Compounds that have been tested in man have included antipyrine, digoxin, propranolol, theophylline, and warfarin and no clinically meaningful interactions were found. |
| Dutasteride | warnings and precautions | … Similar results were observed in a 4-year placebo-controlled clinical trial with another 5α-reductase inhibitor (dutasteride, AVODART) (1% dutasteride vs 0.5% placebo). |
| Propranolol | drug interactions | Compounds that have been tested in man have included antipyrine, digoxin, propranolol, theophylline, and warfarin and no clinically meaningful interactions were found. |
| Testosterone | contraindications | Because of the ability of Type II 5α-reductase inhibitors to inhibit the conversion of testosterone to 5α-dihydrotestosterone (DHT), finasteride may cause abnormalities of the external genitalia of a male fetus of a pregnant female who receives finasteride. |
| Theophylline | drug interactions | Compounds that have been tested in man have included antipyrine, digoxin, propranolol, theophylline, and warfarin and no clinically meaningful interactions were found. |
| Warfarin | drug interactions | Compounds that have been tested in man have included antipyrine, digoxin, propranolol, theophylline, and warfarin and no clinically meaningful interactions were found. |
Source: FDA drug label (PROSCAR), Organon LLC, effective March 18, 2026 (SPL set 6f988153-fc74-4ca4-b29a-111f750c4a4b), via openFDA; the full label on DailyMed
What do FAERS reports show for finasteride?
The FDA Adverse Event Reporting System holds 59,983 reports that list finasteride among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 5,092 are coded as a death and 16,027 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as finasteride?
6 other medicines are given the same way (oral) and in the same FDA class as finasteride or labeled mainly for the same use (enlarged prostate (bph)), the same class first. Enlarged prostate (BPH) lists all 8 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Dutasteride | Enlarged prostate (BPH) | 13 labelers | $0.157 per capsule 0.5 mg capsule | No current entry |
| Doxazosin | Enlarged prostate (BPH) | 29 labelers | $0.0752 per tablet 1 mg tablet | No current entry |
| Terazosin | Enlarged prostate (BPH) | 21 labelers | $0.106 per capsule 2 mg capsule | No current entry |
| Tamsulosin | Enlarged prostate (BPH) | 37 labelers | $0.05 per capsule 0.4 mg capsule | No current entry |
| Silodosin | Enlarged prostate (BPH) | 13 labelers | $0.319 per capsule 8 mg capsule | No current entry |
| Alfuzosin | Enlarged prostate (BPH) | 10 labelers | $0.105 per tablet 10 mg tablet | No current entry |
Every medicine labeled for the same conditions as finasteride
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does finasteride compare with medicines for the same use?
7 side-by-side pages set finasteride beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to finasteride
- 6 medicines for the same use
- Other 5-alpha reductase inhibitors
- the pharmacologic class, with prices and generics
- Finasteride side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other