Quick answers
- What is Telmisartan used for?
- The FDA-approved label (Telmisartan, Remedyrepack Inc., August 11, 2026) says: “Telmisartan is an angiotensin II receptor blocker (ARB) indicated for: Treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Telmisartan have a boxed warning?
- Yes. The FDA label for Telmisartan 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 Telmisartan?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Telmisartan been recalled?
- FDA enforcement reports list 1 recall of products of this medicine; the newest started March 17, 2021 (Class I). A recall usually concerns specific lots, not every product.
- Who makes Telmisartan?
- 27 companies list prescription products of Telmisartan in the FDA NDC Directory, including Bryant Ranch Prepack, Preferred Pharmaceuticals Inc. and NorthStar RxLLC.
What Telmisartan is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Telmisartan is an angiotensin II receptor blocker (ARB) indicated for: Treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. …
— FDA label: Telmisartan, Remedyrepack Inc., effective August 11, 2026. Read the full label on DailyMed →
The FDA has 38 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 →
37 of 38 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet |
|---|---|
| Route | Oral |
| Prescription products | 80 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 |
|---|---|---|
| telmisartan 20 mg tablet | Generic | $0.1098 per tablet |
| telmisartan 40 mg tablet | Generic | $0.1530 per tablet |
| telmisartan 80 mg tablet | Generic | $0.1781 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.
- Bryant Ranch Prepack8 products
- Preferred Pharmaceuticals Inc.5 products
- NorthStar RxLLC3 products
- Alembic Pharmaceuticals Limited3 products
- Amneal Pharmaceuticals LLC3 products
- Zydus Lifesciences Limited3 products
- Ascend Laboratories, LLC3 products
- Zydus Pharmaceuticals USA Inc.3 products
- Modavar Pharmaceuticals LLC3 products
- AvKARE3 products
- Jubilant Cadista Pharmacuticals Inc.3 products
- Glenmark Pharmaceuticals Inc., USA3 products
- Mylan Pharmaceuticals Inc.3 products
- Remedyrepack Inc.3 products
- Aurobindo Pharma Limited3 products
- Lifestar Pharma LLC3 products
- Amneal Pharmaceuticals of New York LLC3 products
- Macleods Pharmaceuticals Limited3 products
- Solco Healthcare US, LLC3 products
- Alembic Pharmaceuticals Inc.3 products
- Cadila Pharmaceuticals Limited3 products
- Chartwell RX, LLC3 products
- A-S Medication Solutions2 products
- NuCare Pharmaceuticals, Inc.2 products
- Proficient Rx LP1 product
- Redpharm Drug1 product
- PD-Rx Pharmaceuticals, Inc.1 product
FDA approval history
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
Generic approvals (13)
- ANDA078710Chartwell Rx · January 8, 2014
- ANDA090032Glenmark Pharms Ltd · July 7, 2014
- ANDA202130Alembic · July 7, 2014
- ANDA202397Mylan · July 7, 2014
- ANDA203325Zydus Pharms · August 26, 2014
- ANDA206511Aurobindo Pharma · September 3, 2015
- ANDA204415Amneal Pharms · September 8, 2015
- ANDA205150Adaptis · October 30, 2015
- ANDA204164Jubilant Generics · August 22, 2016
- ANDA207882Prinston Inc · May 3, 2017
- ANDA208605Cadila Pharms Ltd · July 25, 2017
- ANDA218157Mankind Pharma · October 15, 2024
- ANDA203986Macleods Pharms · January 15, 2025
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.
-
March 17, 2021 · Class I · Terminated · D-0326-2021
Labeling: Label-mixup
Telmisartan Tablets, USP 20 mg, 30-count bottles, Rx only, Manufactured by: Alembic Pharmaceuticals Limited (Formulation Division) Panelav 38935, Gujarat, India Manufactured for: Alembic Pharmaceuticals, Inc. 750 Route 2 — Alembic Pharmaceuticals Limited
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) | 205304, 205305, 282755 |
|---|---|
| SPL set ID of the quoted label | 57da6ef2-2e86-4e4d-90df-73a2a8cf97f6 |
| FDA labels (SPL) | 38 |
| FDA applications | 13 ANDA |
| Active ingredients (FDA) | TELMISARTAN |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Telmisartan, Remedyrepack Inc., effective August 11, 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 →