Quick answers
- What is Nisoldipine used for?
- The FDA-approved label (Sular, Covis Pharma US, Inc, March 12, 2026) says: “SULAR is indicated for the treatment of hypertension. It may be used alone or in combination with other anti-hypertensive agents.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Nisoldipine have a boxed warning?
- No. None of the 3 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Nisoldipine?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Nisoldipine been recalled?
- FDA enforcement reports list 1 recall of products of this medicine; the newest started July 24, 2015 (Class III). A recall usually concerns specific lots, not every product.
- Who makes Nisoldipine?
- 3 companies list prescription products of Nisoldipine in the FDA NDC Directory, including Covis Pharma US, Inc, Prasco Laboratories and Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc..
What Nisoldipine is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
SULAR is indicated for the treatment of hypertension. It may be used alone or in combination with other anti-hypertensive agents.
— FDA label: Sular, Covis Pharma US, Inc, effective March 12, 2026. 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.
The label quoted above has no boxed warning.
0 of 3 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet, film coated, extended release |
|---|---|
| Route | Oral |
| Prescription products | 8 in the FDA NDC Directory |
| Brand names | Sular |
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 |
|---|---|---|
| nisoldipine 17 mg tablet, film coated, extended release | Generic | $4.66 per tablet |
| nisoldipine 34 mg tablet, film coated, extended release | Generic | $5.24 per tablet |
| nisoldipine 8.5 mg tablet, film coated, extended release | Generic | $3.56 per tablet |
NADAC list of November 4, 2026; these prices took effect between November 19, 2025 and August 19, 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.
- Covis Pharma US, Inc3 products
- Prasco Laboratories3 products
- Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals 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 |
|---|---|---|---|
| NDA020356 SULAR | Azurity | February 2, 1995 | 17, latest June 13, 2017 2017: Labeling · 2016: Manufacturing (CMC) · 2008: Manufacturing (CMC) |
Generic approvals (1)
- ANDA216606Amta · April 10, 2023
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.
-
July 24, 2015 · Class III · Terminated · D-1284-2015
Failed Dissolution Specifications
Nisoldipine Extended Release Tablets, 17 mg, packaged as a) Sular (nisoldipine) Extended Release tablets, 100-count bottle (NDC 59630-501-10, UPC 3 59630 50110 5), Manufactured for: Shionogi, Inc., Florham Park, NJ 07932 — Shionogi 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
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Sular, Covis Pharma US, Inc, effective March 12, 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 →