Prescription medicine

Nicardipine Brand names: Cardene

Nicardipine (Cardene) is a prescription medicine with an FDA approval on record since 1988. FDA's NDC Directory lists it from 25 generic labelers, and pharmacies paid $1.12 per nicardipine 20 mg capsule in the October 7, 2026 NADAC survey.

Generic listed

Check it at the source: the nicardipine FDA label on DailyMed (effective August 24, 2024, Hikma Pharmaceuticals USA Inc.); the NDA 19488 record on Drugs@FDA; every nicardipine label on DailyMed.

Highlights of the record

FDA label of August 24, 2024; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026

Used for

From the label: indications and usage
Nicardipine hydrochloride injection, USP is a calcium channel blocker indicated for the short-term treatment of hypertension when oral therapy is not feasible.

Forms and strengths

20 mg
30 mg
0.1 mg/ml
0.2 mg/ml
2.5 mg/ml
2.5 mg/10ml
25 mg/10ml

Injection; capsule; injection (solution).

On the market

Earliest approval on file: December 21, 1988 Cardene, Chiesi; Drugs@FDA’s file, where older or withdrawn approvals can be missing
Generic approvals: 25 first July 18, 1996; 18 with a marketed status in Drugs@FDA
Labelers listed (NDC): 29 of which 25 under generic applications, 4 under brand applications, repackagers included
Last listed patent: December 26, 2027 Cardene injection; not a generic launch date

Supply and safety

Pharmacy cost (NADAC): $1.12 per capsule Nicardipine 20 mg capsule
Shortage (FDA): No current entry
Recalls by its makers (FDA): 10 since 2013 0 Class I among all firms' recalls; latest August 6, 2026; 1 more by firms not listed as its makers
FAERS reports: 4,340 through July 30, 2026

What is nicardipine used for?

From the label: indications and usage
Nicardipine hydrochloride injection, USP is a calcium channel blocker indicated for the short-term treatment of hypertension when oral therapy is not feasible. 1.1 Hypertension Nicardipine hydrochloride injection, USP is indicated for the short-term treatment of hypertension when oral therapy is not feasible or desirable. For prolonged control of blood pressure, transfer patients to oral medication as soon as their clinical condition permits [see Dosage and Administration (2.6) ].

Conditions named in the indications of nicardipine's FDA labels, with every medicine labeled for each:

From other nicardipine labels
Angina: INDICATIONS AND USAGE I. Stable Angina Nicardipine hydrochloride capsules are indicated for the management of patients with chronic stable angina (effort-associated angina).

FDA pharmacologic class: Dihydropyridine Calcium Channel Blocker.

Source: FDA drug label (Nicardipine Hydrochloride), Hikma Pharmaceuticals USA Inc., effective August 24, 2024 (SPL set 18fb1c2b-0c1e-436c-a5b6-d4840b5da228), via openFDA; the full label on DailyMed

Is there a generic for nicardipine (Cardene)?

The FDA approved the first generic nicardipine on July 18, 1996. 25 generic applications are approved; 18 of them carry 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 nicardipine from 25 labelers under a generic (ANDA) application and from 4 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.

The Orange Book lists 6 patents for Cardene injection, the last expiring on December 26, 2027. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.

1988 earliest approval on file
1996 first generic approved
2027 last listed patent
red ticks recalls

Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)

What do pharmacies pay for nicardipine (Cardene)?

In CMS's NADAC survey of October 7, 2026, pharmacies paid $1.12 per Nicardipine 20 mg capsule, down 4% from $1.17 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.

Nicardipine 20 mg capsule (generic)

$3.38

$1.12

April 2024October 2026

NADAC per unit, October 7, 2026
Strength and form	Brand or generic	Pharmacy cost	30 tablets, or one pen or vial	12-month change
Nicardipine 20 mg capsule	Generic	$1.12 per capsule	$33.60	-4%

Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price

Has nicardipine been recalled?

The FDA's Enforcement Report lists 11 recalls naming nicardipine since 2013: 0 Class I (the most serious), 9 Class II, 2 Class III; 6 still ongoing. 1 of them is by a firm that FDA's NDC Directory does not list as a maker of nicardipine and that holds no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.

Started	Class	Company	Reason
August 6, 2026	Class II	Baxter Healthcare Corporation	CGMP Deviations
July 24, 2026	Class II	American Regent, Inc.	Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
April 18, 2025	Class II	American Regent, Inc.	Lack of sterility assurance: Product leakage around the vial neck, which could potentially result in a lack of sterility assurance.
May 14, 2024	Class II	American Regent, Inc.	Lack of Assurance of Sterility.
February 20, 2024	Class II	Eugia US LLC	Failed Impurities/Degradation Specifications: Out of specification for organic impurities
March 16, 2020	Class II	PharMEDium Services, LLC	Firm is recalling 46 lots of various products because of a lack of sterility assurance.
April 12, 2019	Class II	CMC Enterprise Pharmacy not a listed maker	Lack of sterility assurance.
January 23, 2015	Class III	Mylan Institutional LLC	Subpotent Drug and Failed Impurities/Degradation Specifications

Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026

What does the nicardipine label say about other medicines?

The nicardipine label names 10 other medicines in its interaction, contraindication or warning sections. The labels of 19 other medicines name nicardipine. 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
Cimetidine	drug interactions	DRUG INTERACTIONS Cimetidine increases nicardipine plasma levels ( 7.3 ). Nicardipine may increase cyclosporine and tacrolimus plasma levels.
Cyclosporine	drug interactions	DRUG INTERACTIONS Cimetidine increases nicardipine plasma levels ( 7.3 ). Nicardipine may increase cyclosporine and tacrolimus plasma levels.
Digoxin	drug interactions	Studies have shown that oral nicardipine usually does not alter digoxin plasma concentrations.
Dipyridamole	drug interactions	The plasma protein binding of nicardipine was not altered when therapeutic concentrations of furosemide, propranolol, dipyridamole, warfarin, quinidine, or naproxen were added to human plasma in vitro.
Furosemide	drug interactions	The plasma protein binding of nicardipine was not altered when therapeutic concentrations of furosemide, propranolol, dipyridamole, warfarin, quinidine, or naproxen were added to human plasma in vitro.
Naproxen	drug interactions	The plasma protein binding of nicardipine was not altered when therapeutic concentrations of furosemide, propranolol, dipyridamole, warfarin, quinidine, or naproxen were added to human plasma in vitro.
Propranolol	drug interactions	The plasma protein binding of nicardipine was not altered when therapeutic concentrations of furosemide, propranolol, dipyridamole, warfarin, quinidine, or naproxen were added to human plasma in vitro.
Quinidine	drug interactions	The plasma protein binding of nicardipine was not altered when therapeutic concentrations of furosemide, propranolol, dipyridamole, warfarin, quinidine, or naproxen were added to human plasma in vitro.
Tacrolimus	drug interactions	DRUG INTERACTIONS Cimetidine increases nicardipine plasma levels ( 7.3 ). Nicardipine may increase cyclosporine and tacrolimus plasma levels.
Warfarin	drug interactions	The plasma protein binding of nicardipine was not altered when therapeutic concentrations of furosemide, propranolol, dipyridamole, warfarin, quinidine, or naproxen were added to human plasma in vitro.

Other labels that name nicardipine

Check nicardipine against other medicines

What do FAERS reports show for nicardipine?

The FDA Adverse Event Reporting System holds 4,340 reports that list nicardipine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 582 are coded as a death and 2,314 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

Acute Kidney Injury243
Off Label Use (a use or a product term, not a reaction)211
Premature Baby205
Foetal Exposure During Pregnancy (a use or a product term, not a reaction)195
Drug Ineffective (a use or a product term, not a reaction)192
Maternal Exposure During Pregnancy (a use or a product term, not a reaction)183
Hypotension (named in the label)172
Drug Interaction (a use or a product term, not a reaction)167

Side effects: the label's list and every FAERS reaction

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026

What else is labeled for the same conditions as nicardipine?

73 other medicines are given the same way (oral) and in the same FDA class as nicardipine 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, Angina	42 labelers	$0.0102 per tablet 5 mg tablet	No current entry
Nifedipine	High blood pressure, Angina	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, Angina	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 nicardipine

Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)

How does nicardipine compare with medicines for the same use?

7 side-by-side pages set nicardipine beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.

What next?

Alternatives to nicardipine: 73 medicines for the same use
Other calcium channel blockers: the pharmacologic class, with prices and generics
Nicardipine side effects: the label's list beside FAERS reports
Check an interaction: what two or more labels say about each other