Quick answers
- What is Trandolapril used for?
- The FDA-approved label (Trandolapril, Lupin Pharmaceuticals, Inc., October 31, 2025) says: “Hypertension Trandolapril tablets are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medication such as hydrochlorothiazide. Heart Failure Post Myocardial Infarction or Left-Ventricular Dysfunction Post Myocardial Infarction Trandolapril tablets are indicated in stable patients who have evidence of left-ventricular systolic dysfunction (identified by …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Trandolapril have a boxed warning?
- Yes. The FDA label for Trandolapril has a boxed warning (“WARNING: FETAL TOXICITY”), the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Trandolapril?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Trandolapril been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Trandolapril?
- 5 companies list prescription products of Trandolapril in the FDA NDC Directory, including Rising Pharma Holdings, Inc., Lupin Pharmaceuticals, Inc. and Aurobindo Pharma Limited.
What Trandolapril is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Hypertension Trandolapril tablets are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medication such as hydrochlorothiazide. Heart Failure Post Myocardial Infarction or Left-Ventricular Dysfunction Post Myocardial Infarction Trandolapril tablets are indicated in stable patients who have evidence of left-ventricular systolic dysfunction (identified by …
— FDA label: Trandolapril, Lupin Pharmaceuticals, Inc., effective October 31, 2025. Read the full label on DailyMed →
The FDA has 6 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.
This label has a boxed warning. Its heading: WARNING: FETAL TOXICITY
. Read it on the full label →
6 of 6 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet |
|---|---|
| Route | Oral |
| Prescription products | 14 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 |
|---|---|---|
| trandolapril 1 mg tablet | Generic | $0.1646 per tablet |
| trandolapril 2 mg tablet | Generic | $0.1626 per tablet |
| trandolapril 4 mg tablet | Generic | $0.1675 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.
- Rising Pharma Holdings, Inc.3 products
- Lupin Pharmaceuticals, Inc.3 products
- Aurobindo Pharma Limited3 products
- Epic Pharma, LLC3 products
- Bryant Ranch Prepack2 products
FDA approval history
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
Generic approvals (3)
- ANDA077522Lupin · June 12, 2007
- ANDA078438Aurobindo Pharma · June 12, 2007
- ANDA078508Epic Pharma · June 18, 2008
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) | 199351, 199352, 199353 |
|---|---|
| SPL set ID of the quoted label | 8143a6cf-dadc-4ef7-a8db-d16d7150ad34 |
| FDA labels (SPL) | 6 |
| FDA applications | 3 ANDA |
| Active ingredients (FDA) | TRANDOLAPRIL |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Trandolapril, Lupin Pharmaceuticals, Inc., effective October 31, 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 →