Quick answers
- What is Aliskiren hemifumarate used for?
- The FDA-approved label (Tekturna, LXO US Inc., March 7, 2024) says: “Tekturna is a renin inhibitor (RI) indicated for the treatment of hypertension in adults and in pediatric patients weighing 50 kg or greater who are at least 6 years of age, 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 Aliskiren hemifumarate have a boxed warning?
- Yes. The FDA label for Tekturna 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 Aliskiren hemifumarate?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Aliskiren hemifumarate been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Aliskiren hemifumarate?
- 3 companies list prescription products of Aliskiren hemifumarate in the FDA NDC Directory, including Par Health USA, LLC, Prasco Laboratories and LXO US Inc..
What Aliskiren hemifumarate is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Tekturna is a renin inhibitor (RI) indicated for the treatment of hypertension in adults and in pediatric patients weighing 50 kg or greater who are at least 6 years of age, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. …
— FDA label: Tekturna, LXO US Inc., effective March 7, 2024. Read the full label on DailyMed →
The FDA has 3 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 →
3 of 3 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet, film coated |
|---|---|
| Route | Oral |
| Prescription products | 6 in the FDA NDC Directory |
| Brand names | Tekturna |
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 |
|---|---|---|
| aliskiren hemifumarate 150 mg tablet, film coated | Generic | $3.89 per tablet |
| aliskiren hemifumarate 300 mg tablet, film coated | Generic | $5.99 per tablet |
| aliskiren hemifumarate 300 mg tablet, film coated | Brand: Tekturna | $15.09 per tablet |
NADAC list of November 4, 2026; these prices took effect between January 6, 2026 and 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.
- Par Health USA, LLC2 products
- Prasco Laboratories2 products
- LXO US Inc.2 products
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 |
|---|---|---|---|
| NDA021985 TEKTURNA | Lxo Ireland | March 5, 2007 | 18, latest June 17, 2020 2020: Labeling · 2017: Labeling · 2016: Labeling |
Generic approvals (1)
- ANDA206665Ph Health · March 22, 2019
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) | 1011736, 1011738, 1011739, 1011741 |
|---|---|
| SPL set ID of the quoted label | 3dd61fa5-1620-4ebf-bbdb-ede29b92fce2 |
| FDA labels (SPL) | 3 |
| FDA applications | NDA021985, 1 ANDA |
| Active ingredients (FDA) | ALISKIREN HEMIFUMARATE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Tekturna, LXO US Inc., effective March 7, 2024; 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 →