Quick answers
- What is Dutasteride used for?
- The FDA-approved label (Dutasteride, Strides Pharma Science Limited, August 27, 2026) says: “Dutasteride is a 5 alpha-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, and reduce the risk of the need for BPH-related surgery. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Dutasteride have a boxed warning?
- No. None of the 21 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Dutasteride?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Dutasteride been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Dutasteride?
- 13 companies list prescription products of Dutasteride in the FDA NDC Directory, including Bryant Ranch Prepack, NuCare Pharmaceuticals, Inc. and A-S Medication Solutions.
What Dutasteride is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Dutasteride is a 5 alpha-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, and reduce the risk of the need for BPH-related surgery. …
— FDA label: Dutasteride, Strides Pharma Science Limited, effective August 27, 2026. Read the full label on DailyMed →
The FDA has 21 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 21 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Capsule, liquid filled · Capsule |
|---|---|
| Route | Oral |
| Prescription products | 22 in the FDA NDC Directory |
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 |
|---|---|---|
| dutasteride 0.5 mg capsule | Generic | $0.1550 per capsule |
| dutasteride 0.5 mg capsule, liquid filled | Generic | $0.1550 per capsule |
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.
- Bryant Ranch Prepack4 products
- NuCare Pharmaceuticals, Inc.4 products
- A-S Medication Solutions3 products
- Proficient Rx LP2 products
- Banyan Pharma LLC1 product
- XLCare Pharmaceuticals, Inc.1 product
- Marksans Pharma Limited1 product
- Amneal Pharmaceuticals LLC1 product
- Camber Pharmaceuticals, Inc.1 product
- Strides Pharma Science Limited1 product
- Epic Pharma, LLC1 product
- AvKARE1 product
- Aurobindo Pharma Limited1 product
FDA approval history
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
Generic approvals (7)
- ANDA202660Aurobindo Pharma Ltd · November 20, 2015
- ANDA203118Amneal Pharms · November 20, 2015
- ANDA204262Onesource · November 20, 2015
- ANDA204705Pharmobedient · November 20, 2015
- ANDA206574Ascent Pharms Inc · October 21, 2016
- ANDA204376Pharmazone · April 7, 2017
- ANDA209909Humanwell Puracap · November 21, 2017
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 351172 |
|---|---|
| SPL set ID of the quoted label | c78d18cf-05df-4154-b2f9-39cc374ca9e3 |
| FDA labels (SPL) | 21 |
| FDA applications | 7 ANDA |
| Active ingredients (FDA) | DUTASTERIDE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Dutasteride, Strides Pharma Science Limited, effective August 27, 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 →