Quick answers
- What is Terazosin hydrochloride used for?
- The FDA-approved label (Tezruly, ANI Pharmaceuticals, Inc., April 18, 2025) says: “TEZRULY TM (terazosin) is an alpha-1 adrenoceptor antagonist indicated for: The treatment of signs and symptoms of benign prostatic hyperplasia (BPH) The treatment of hypertension alone or with other antihypertensive agents, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarction. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Terazosin hydrochloride have a boxed warning?
- No. None of the 46 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Terazosin hydrochloride?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Terazosin hydrochloride been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Terazosin hydrochloride?
- 20 companies list prescription products of Terazosin hydrochloride in the FDA NDC Directory, including Aphena Pharma Solutions - Tennessee, LLC, Bryant Ranch Prepack and Amerisyn LLC.
What Terazosin hydrochloride is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
TEZRULY TM (terazosin) is an alpha-1 adrenoceptor antagonist indicated for: The treatment of signs and symptoms of benign prostatic hyperplasia (BPH) The treatment of hypertension alone or with other antihypertensive agents, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarction. …
— FDA label: Tezruly, ANI Pharmaceuticals, Inc., effective April 18, 2025. Read the full label on DailyMed →
The FDA has 46 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.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
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 46 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Capsule · Solution |
|---|---|
| Route | Oral |
| Prescription products | 88 in the FDA NDC Directory |
| Brand names | Tezruly |
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 |
|---|---|---|
| terazosin hydrochloride 1 mg capsule | Generic | $0.1018 per capsule |
| terazosin hydrochloride 10 mg capsule | Generic | $0.1284 per capsule |
| terazosin hydrochloride 2 mg capsule | Generic | $0.1068 per capsule |
| terazosin hydrochloride 5 mg capsule | Generic | $0.1088 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.
- Aphena Pharma Solutions - Tennessee, LLC12 products
- Bryant Ranch Prepack11 products
- Amerisyn LLC8 products
- A-S Medication Solutions5 products
- Remedyrepack Inc.5 products
- Preferred Pharmaceuticals Inc.5 products
- Ajanta Pharma USA Inc.4 products
- AvKARE4 products
- Amici Pharma, Inc.4 products
- Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.4 products
- Apnar Pharma LP4 products
- AvPAK4 products
- Jubilant Cadista Pharmaceuticals Inc.4 products
- Chartwell RX, LLC4 products
- Bionpharma Inc.4 products
- Proficient Rx LP2 products
- Northwind Health Company, LLC1 product
- NuCare Pharmaceuticals, Inc.1 product
- ANI Pharmaceuticals, Inc.1 product
- Coupler LLC1 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 |
|---|---|---|---|
| NDA218139 TEZRULY | Novitium Pharma | July 29, 2024 | — |
Generic approvals (5)
- ANDA074823Pharmazone · March 30, 1998
- ANDA075667Bionpharma · July 28, 2000
- ANDA075614Heritage Pharma Avet · January 30, 2001
- ANDA075317Jubilant Cadista · December 20, 2004
- ANDA219482Ajanta Pharma Ltd · May 12, 2025
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
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Tezruly, ANI Pharmaceuticals, Inc., effective April 18, 2025; 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 →