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Prescription medicine · generic available

Ivabradine

Official FDA data, not advice

Everything here comes from the U.S. Food and Drug Administration (FDA): the drug label, the NDC Directory, Drugs@FDA, recall reports and the drug shortage list. Each fact shows its source and date.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

In an emergency, call 911. If someone may have taken too much of a medicine, call Poison Help: 1‑800‑222‑1222.

Quick answers

What is Ivabradine used for?
The FDA-approved label (Corlanor, Amgen Inc, November 10, 2025) says: “1. INDICATIONS AND USAGE Corlanor (ivabradine) is a hyperpolarization-activated cyclic nucleotide-gated channel blocker indicated: To reduce the risk of hospitalization for worsening heart failure in adult patients with stable, symptomatic chronic heart failure with reduced left ventricular ejection fraction. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Does Ivabradine have a boxed warning?
No. None of the 12 FDA labels we found for this medicine has a boxed warning.
Is there a shortage of Ivabradine?
The FDA drug shortage list shows “To be discontinued” for a product of this medicine (updated March 24, 2026). Ask your pharmacist about alternatives.
Has Ivabradine been recalled?
FDA enforcement reports list 2 recalls of products of this medicine; the newest started June 4, 2026 (Class II). A recall usually concerns specific lots, not every product.
Who makes Ivabradine?
12 companies list prescription products of Ivabradine in the FDA NDC Directory, including Amgen, Inc, Novadoz Pharmaceuticals LLC and NorthStar Rx LLC.

What Ivabradine is used for

Quoted from the “Indications and Usage” section of the FDA-approved label.

1. INDICATIONS AND USAGE Corlanor (ivabradine) is a hyperpolarization-activated cyclic nucleotide-gated channel blocker indicated: To reduce the risk of hospitalization for worsening heart failure in adult patients with stable, symptomatic chronic heart failure with reduced left ventricular ejection fraction. …

— FDA label: Corlanor, Amgen Inc, effective November 10, 2025. Read the full label on DailyMed →

The FDA has 12 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 12 FDA labels for this medicine have a boxed warning.

Forms and how it is given

Dosage formsTablet, film coated · Tablet · Solution
RouteOral
Prescription products24 in the FDA NDC Directory
Brand namesCorlanor

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.

NADAC per unit for Ivabradine, by strength and form
Strength and formGeneric or brandPharmacies pay
ivabradine hydrochloride 5 mg
tablet
Generic $0.7103 per tablet
ivabradine hydrochloride 5 mg
tablet, film coated
Generic $0.7103 per tablet
ivabradine hydrochloride 5 mg
tablet, film coated
Brand: Corlanor $10.00 per tablet
ivabradine hydrochloride 7.5 mg
tablet
Generic $0.6026 per tablet
ivabradine hydrochloride 7.5 mg
tablet, film coated
Generic $0.6026 per tablet
ivabradine hydrochloride 7.5 mg
tablet, film coated
Brand: Corlanor $10.02 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.

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.
Brand and biologic applications
ApplicationSponsorApprovedLater changes approved
NDA206143
CORLANOR
Amgen IncApril 15, 2015 4, latest August 4, 2021
2021: Labeling · 2019: Labeling · 2017: Labeling
NDA209964
CORLANOR
Amgen IncApril 22, 2019 1, latest August 4, 2021
2021: Labeling

Generic approvals (6)

Shortage status

To be discontinued · updated March 24, 2026 · first posted March 24, 2026

ProductCorlanor, Tablet, eq. 7.5 mg base (NDC 55513-810-60)
CompanyAmgen Inc.

Ask your pharmacist whether your product is affected and what the options are.

FDA Drug Shortages database →

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.

  1. June 4, 2026 · Class II · Ongoing · D-0612-2026

    Presence of Foreign Substance.

    Corlanor (ivabradine) tablets, 5 mg, packaged in a) 14 tablets bottles (NDC 55513-800-99), and b) 60 tablet bottles (NDC 55513-800-60), Rx Only, Amgen Inc., Thousand Oaks, CA 92130 Made In Italy. — Amgen, Inc.

  2. June 4, 2026 · Class II · Ongoing · D-0615-2026

    Presence of Foreign Substance.

    Corlanor (ivabradine) tablets, 7.5mg, 60-count bottles, Rx Only, Amgen Inc., Thousand Oaks, CA 92130 Made In Italy. NDC 55513-810-60 — Amgen, Inc.

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)1649485, 1649491, 1649493, 1649495, 2168592, 2168596
SPL set ID of the quoted label92018a65-38f6-45f7-91d4-a34921b81d0d
FDA labels (SPL)12
FDA applicationsNDA206143, NDA209964, 6 ANDA
Active ingredients (FDA)IVABRADINE

Sources

  1. FDA-approved label on DailyMed (National Library of Medicine) — Corlanor, Amgen Inc, effective November 10, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
  2. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  3. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  4. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
  5. 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 →

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