Prescription medicine

Amlodipine Brand names: Norvasc, Sdamlo, Norliqva, Katerzia

Amlodipine (Norvasc) is a prescription medicine with an FDA approval on record since 1992. FDA's NDC Directory lists it from 42 generic labelers, and pharmacies paid $0.0102 per amlodipine besylate 5 mg tablet in the October 7, 2026 NADAC survey.

Generic listed

Check it at the source: the amlodipine FDA label on DailyMed (effective February 15, 2023, Viatris Specialty LLC); the NDA 19787 record on Drugs@FDA; every amlodipine label on DailyMed.

Highlights of the record

FDA label of February 15, 2023; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026

Used for

From the label: indications and usage
NORVASC is a calcium channel blocker and may be used alone or in combination with other antihypertensive and antianginal agents for the treatment of:
Hypertension ( 1.1 ) o NORVASC is indicated for the treatment of hypertension, to lower blood pressure.

Forms and strengths

2.5 mg
5 mg
10 mg
1 mg/ml

Tablet; solution; suspension.

On the market

Earliest approval on file: July 31, 1992 Norvasc, Viatris; Drugs@FDA’s file, where older or withdrawn approvals can be missing
Generic approvals: 40 first October 3, 2005; 19 with a marketed status in Drugs@FDA
Labelers listed (NDC): 48 of which 42 under generic applications, 5 under brand applications, repackagers included
Last listed patent: February 24, 2041 Norliqva oral solution; not a generic launch date

Supply and safety

Pharmacy cost (NADAC): $0.0102 per tablet Amlodipine besylate 5 mg tablet
Shortage (FDA): No current entry
Recalls by its makers (FDA): 30 since 2013 0 Class I among all firms' recalls; latest June 27, 2023
FAERS reports: 409,186 through July 30, 2026

What is amlodipine used for?

From the label: indications and usage
NORVASC is a calcium channel blocker and may be used alone or in combination with other antihypertensive and antianginal agents for the treatment of:
Hypertension ( 1.1 ) o NORVASC is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. […]

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

From other amlodipine labels
Angina: Disease (CAD) Chronic Stable Angina NORVASC is indicated for the symptomatic treatment of chronic stable angina.
Heart attack and coronary artery disease: Coronary Artery Disease

FDA pharmacologic class: Calcium Channel Blocker and Dihydropyridine Calcium Channel Blocker.

Source: FDA drug label (Norvasc), Viatris Specialty LLC, effective February 15, 2023 (SPL set 7367289c-b0b0-466a-83e2-558e2985c29f), via openFDA; the full label on DailyMed

What does the patient leaflet for amlodipine say first?

The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.

From the patient leaflet: What should I avoid while taking NORVASC?
Do not start any new prescription or non-prescription medicines or supplements, unless you check with your doctor first.

Source: FDA drug label (Norvasc), Viatris Specialty LLC, effective February 15, 2023 (SPL set 7367289c-b0b0-466a-83e2-558e2985c29f), via openFDA; the full label on DailyMed

Is there a generic for amlodipine (Norvasc)?

The FDA approved the first generic amlodipine on October 3, 2005. 40 generic applications are approved; 19 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 amlodipine from 42 labelers under a generic (ANDA) application and from 5 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 no patent for Norvasc tablets; a patent listed only for Norliqva oral solution runs to February 24, 2041. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.

1992 earliest approval on file
2005 first generic approved
2041 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 amlodipine (Norvasc)?

In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.0102 per Amlodipine besylate 5 mg tablet, down 10% from $0.0113 on October 8, 2025. Prices per unit in the table differ many-fold by strength, form and brand, so compare like with like. 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.

Amlodipine besylate 5 mg tablet (generic)
Norvasc 5 mg tablet (brand)

$8.70

$0.0095

January 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
Amlodipine besylate 10 mg tablet	Generic	$0.0148 per tablet	$0.444	-12%
Amlodipine besylate 2.5 mg tablet	Generic	$0.0106 per tablet	$0.318	+3%
Amlodipine besylate 5 mg tablet	Generic	$0.0102 per tablet	$0.305	-10%
Katerzia 1 mg/mL suspension	Brand	$4.20 per mL	n/a	+3%
Norliqva 1 mg/mL solution	Brand	$3.22 per mL	n/a	-2%
Norvasc 10 mg tablet	Brand	$11.94 per tablet many times the lowest per-tablet cost; NADAC records the price, not why	$358.25	+6%
Norvasc 2.5 mg tablet	Brand	$8.70 per tablet many times the lowest per-tablet cost; NADAC records the price, not why	$261.11	+5%
Norvasc 5 mg tablet	Brand	$8.69 per tablet many times the lowest per-tablet cost; NADAC records the price, not why	$260.79	+5%

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

Has amlodipine been recalled?

The FDA's Enforcement Report lists 30 recalls naming amlodipine since 2013: 0 Class I (the most serious), 24 Class II, 6 Class III; 9 still ongoing. A recall names products and lots, not every product of the medicine.

Started	Class	Company	Reason
June 27, 2023	Class III	Lupin Pharmaceuticals Inc.	Subpotent Drug: Out-of-Specification test results observed in assay test at 21-month long term stability study.
November 27, 2018	Class II	Teva Pharmaceuticals USA	CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
October 3, 2018	Class III	InvaGen Pharmaceuticals, Inc.	Subpotent Drug: One lot of product does not meet the product specification for Assay test at 3 month long term stability condition.
August 17, 2018	Class II	Torrent Pharma Inc.	CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
May 5, 2017	Class III	Ascend Laboratories LLC	PRESENCE OF FOREIGN TABLETS/CAPSULES: A 2.5 mg Amlodipine Besylate tablet was found co-mingled with 10 mg Amlodipine Besylate tablets in a bottle labeled as …
February 19, 2016	Class III	Lupin Limited	CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
June 1, 2015	Class II	American Health Packaging	CGMP Deviations: Firm did not adequately investigate customer complaints.
April 22, 2015	Class II	Wockhardt Usa Inc.	CGMP Deviations: Firm did not adequately investigate customer complaints.

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

What does the amlodipine label say about other medicines?

The amlodipine label names 14 other medicines in its interaction, contraindication or warning sections. The labels of 28 other medicines name amlodipine. 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
Atorvastatin	drug interactions	Co-administered amlodipine does not affect the exposure to atorvastatin, digoxin, ethanol and the warfarin prothrombin response time.
Cimetidine	drug interactions	Impact of other drugs on amlodipine Co-administered cimetidine, magnesium-and aluminum hydroxide antacids, sildenafil, and grapefruit juice have no impact on the exposure to amlodipine.
Clarithromycin	drug interactions	However, strong inhibitors of CYP3A (e.g., itraconazole, clarithromycin) may increase the plasma concentrations of amlodipine to a greater extent [see Drug Interactions (7.1) ].
Cyclosporine	drug interactions	Immunosuppressants Amlodipine may increase the systemic exposure of cyclosporine or tacrolimus when co-administered.
Digoxin	drug interactions	Co-administered amlodipine does not affect the exposure to atorvastatin, digoxin, ethanol and the warfarin prothrombin response time.
Diltiazem	drug interactions	CYP3A inhibitors: Co-administration of a 180 mg daily dose of diltiazem with 5 mg amlodipine in elderly hypertensive patients resulted in a 60% increase in amlodipine systemic exposure.
Erythromycin	drug interactions	Erythromycin co-administration in healthy volunteers did not significantly change amlodipine systemic exposure.
Indomethacin	drug interactions	Drug interactions In vitro data indicate that amlodipine has no effect on the human plasma protein binding of digoxin, phenytoin, warfarin, and indomethacin.
Itraconazole	drug interactions	However, strong inhibitors of CYP3A (e.g., itraconazole, clarithromycin) may increase the plasma concentrations of amlodipine to a greater extent [see Drug Interactions (7.1) ].
Phenytoin	drug interactions	Drug interactions In vitro data indicate that amlodipine has no effect on the human plasma protein binding of digoxin, phenytoin, warfarin, and indomethacin.
Sildenafil	drug interactions	Sildenafil Monitor for hypotension when sildenafil is co-administered with amlodipine [see Clinical Pharmacology (12.2) ].
Simvastatin	drug interactions	Amlodipine on Other Drugs Simvastatin Co-administration of simvastatin with amlodipine increases the systemic exposure of simvastatin.
Tacrolimus	drug interactions	Immunosuppressants Amlodipine may increase the systemic exposure of cyclosporine or tacrolimus when co-administered.
Warfarin	drug interactions	Co-administered amlodipine does not affect the exposure to atorvastatin, digoxin, ethanol and the warfarin prothrombin response time.

Other labels that name amlodipine

Check amlodipine against other medicines

Source: FDA drug label (Norvasc), Viatris Specialty LLC, effective February 15, 2023 (SPL set 7367289c-b0b0-466a-83e2-558e2985c29f), via openFDA; the full label on DailyMed

What do FAERS reports show for amlodipine?

The FDA Adverse Event Reporting System holds 409,186 reports that list amlodipine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 42,260 are coded as a death and 159,402 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

Fatigue (named in the label)25,352
Diarrhoea (named in the label)22,134
Nausea (named in the label)21,663
Dyspnoea (named in the label)20,898
Drug Ineffective (a use or a product term, not a reaction)19,317
Dizziness (named in the label)17,259
Off Label Use (a use or a product term, not a reaction)16,714
Headache16,232

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 amlodipine?

65 other medicines are given the same way (oral) and in the same FDA class as amlodipine 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
Diltiazem	High blood pressure, Angina	42 labelers	$0.144 per capsule 24h ER(cd) 120 mg capsule	A presentation being discontinued
Nifedipine	High blood pressure, Angina	32 labelers	$0.130 per tablet 30 mg tablet	No current entry
Verapamil	High blood pressure, Angina	24 labelers	$0.191 per tablet 180 mg tablet	A presentation being discontinued
Felodipine	High blood pressure	14 labelers	$0.123 per tablet 5 mg tablet	No current entry
Nicardipine	High blood pressure, Angina	9 labelers	$1.12 per capsule 20 mg capsule	No current entry
Nisoldipine	High blood pressure	1 labeler	$5.24 per tablet 34 mg tablet	No current entry
Isradipine	High blood pressure	3 labelers	$1.70 per capsule 5 mg capsule	No current entry
Trandolapril and verapamil	High blood pressure	1 labeler	n/a	No current entry

Every medicine labeled for the same conditions as amlodipine

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

How does amlodipine compare with medicines for the same use?

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

What next?

Alternatives to amlodipine: 65 medicines for the same use
Other calcium channel blockers: the pharmacologic class, with prices and generics
Amlodipine side effects: the label's list beside FAERS reports
Check an interaction: what two or more labels say about each other