Prescription medicine
Nisoldipine Brand names: Sular
Nisoldipine (Sular) is a prescription medicine with an FDA approval on record since 1995. FDA's NDC Directory lists it from 1 generic labeler, and pharmacies paid $5.24 per nisoldipine ER 34 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the nisoldipine FDA label on DailyMed (effective March 12, 2026, Covis Pharma US, Inc); the NDA 20356 record on Drugs@FDA; every nisoldipine label on DailyMed.
Highlights of the record
FDA label of March 12, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageSULAR is indicated for the treatment of hypertension.
Forms and strengths
- 8.5 mg
- 17 mg
- 34 mg
Film-coated extended-release tablet.
On the market
- Earliest approval on file
- February 2, 1995 Sular, Azurity; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 3 first July 25, 2008; 1 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 3 of which 1 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $5.24 per tablet Nisoldipine ER 34 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 2 since 2012 0 Class I among all firms' recalls; latest July 24, 2015
- FAERS reports
- 1,197 through July 30, 2026
What is nisoldipine used for?
From the label: indications and usageSULAR is indicated for the treatment of hypertension. It may be used alone or in combination with other anti-hypertensive agents.
Conditions named in the indications of nisoldipine's FDA labels, with every medicine labeled for each:
From other nisoldipine labelsHigh blood pressure: INDICATIONS AND USAGE SULAR is indicated for the treatment of hypertension.
FDA pharmacologic class: Dihydropyridine Calcium Channel Blocker.
Source: FDA drug label (Sular), NDA020356 (Azurity), as published by Covis Pharma US, Inc, effective March 12, 2026 (SPL set 589157fa-d129-4de3-be3d-e0e1c22c5873), via openFDA; the full label on DailyMed
Is there a generic for nisoldipine (Sular)?
The FDA approved the first generic nisoldipine on July 25, 2008. 3 generic applications are approved; 1 of them carries a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists nisoldipine from 1 labeler under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1995 earliest approval on file
- 2008 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for nisoldipine (Sular)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $5.24 per Nisoldipine ER 34 mg tablet, down 5% from $5.53 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Nisoldipine ER 8.5 mg tablet (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Nisoldipine ER 17 mg tablet | Generic | $4.66 per tablet | $139.77 | -2% |
| Nisoldipine ER 34 mg tablet | Generic | $5.24 per tablet | $157.12 | -5% |
| Nisoldipine ER 8.5 mg tablet | Generic | $3.56 per tablet | $106.80 | +4% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has nisoldipine been recalled?
The FDA's Enforcement Report lists 2 recalls naming nisoldipine since 2012: 0 Class I (the most serious), 1 Class II, 1 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| July 24, 2015 | Class III | Shionogi Inc. | Failed Dissolution Specifications |
| March 8, 2012 | Class II | Shionogi Inc. | Failed USP Dissolution Test Requirements: Out of Specification dissolution result at 18 month time point |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the nisoldipine label say about other medicines?
The nisoldipine label names 8 other medicines in its interaction, contraindication or warning sections. The labels of 9 other medicines name nisoldipine. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Atenolol | drug interactions | Pharmacokinetic interactions between nisoldipine and beta-blockers (atenolol, propranolol) were variable and not significant. |
| Cimetidine | drug interactions | Drug Interactions A 30 to 45% increase in AUC and C max of nisoldipine was observed with concomitant administration of cimetidine 400 mg twice daily. |
| Digoxin | drug interactions | No significant interactions were found between nisoldipine and warfarin or digoxin. |
| Phenytoin | drug interactions | Coadministration of phenytoin with a dose bioequivalent to 34 mg SULAR tablets in epileptic patients lowered the nisoldipine plasma concentrations to undetectable levels. |
| Propranolol | drug interactions | Pharmacokinetic interactions between nisoldipine and beta-blockers (atenolol, propranolol) were variable and not significant. |
| Quinidine | drug interactions | Quinidine at 648 mg bid decreased the bioavailability (AUC) of nisoldipine by 26%, but not the peak concentration. |
| Ranitidine | drug interactions | Ranitidine 150 mg twice daily did not interact significantly with nisoldipine (AUC was decreased by 15 - 20%). |
| Warfarin | drug interactions | No significant interactions were found between nisoldipine and warfarin or digoxin. |
Other labels that name nisoldipine
Source: FDA drug label (Sular), NDA020356 (Azurity), as published by Covis Pharma US, Inc, effective March 12, 2026 (SPL set 589157fa-d129-4de3-be3d-e0e1c22c5873), via openFDA; the full label on DailyMed
What do FAERS reports show for nisoldipine?
The FDA Adverse Event Reporting System holds 1,197 reports that list nisoldipine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 123 are coded as a death and 394 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as nisoldipine?
72 other medicines are given the same way (oral) and in the same FDA class as nisoldipine or labeled mainly for the same use (high blood pressure), the same class first. High blood pressure lists all 88 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Amlodipine | High blood pressure | 42 labelers | $0.0102 per tablet 5 mg tablet | No current entry |
| Nifedipine | High blood pressure | 32 labelers | $0.130 per tablet 30 mg tablet | No current entry |
| Amlodipine and benazepril | High blood pressure | 16 labelers | $0.114 per unit 10-20 mg | No current entry |
| Amlodipine and atorvastatin | High blood pressure | 6 labelers | $1.34 per unit 10-40 mg | No current entry |
| Amlodipine and olmesartan | High blood pressure | 14 labelers | $0.248 per unit 10-20 mg | No current entry |
| Felodipine | High blood pressure | 14 labelers | $0.123 per tablet 5 mg tablet | No current entry |
| Amlodipine and hydrochlorothiazide and olmesartan | High blood pressure | 8 labelers | $0.776 per unit 20-5-12.5 | No current entry |
| Amlodipine and valsartan | High blood pressure | 9 labelers | $0.330 per unit 10-160 mg | No current entry |
Every medicine labeled for the same conditions as nisoldipine
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does nisoldipine compare with medicines for the same use?
1 side-by-side page set nisoldipine beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to nisoldipine
- 72 medicines for the same use
- Other calcium channel blockers
- the pharmacologic class, with prices and generics
- Nisoldipine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other