Amlodipine
Amlodipine is a calcium channel blocker used to treat high blood pressure and certain types of chest pain (angina) and coronary artery disease.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 147 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
Amlodipine is a calcium channel blocker that relaxes and widens the arteries to treat high blood pressure, angina (chest pain from the heart) and coronary artery disease. It is one of the most prescribed blood pressure medicines, often a first choice, on the market since about 1992 and available as a generic. Most people tolerate it well; ankle and foot swelling is what they notice most, more so at higher doses. Call your doctor if chest pain gets worse after starting it or raising the dose, especially with severe coronary artery disease. It raises simvastatin levels, so check with your pharmacist before adding new medicines.
Clinical pearls
- Amlodipine ankle swelling comes from widened blood vessels, not extra fluid, so water pills usually help little; mention it rather than stopping.
- Clarithromycin, itraconazole and diltiazem can raise amlodipine levels, so watch for new dizziness or swelling when one is added.
- If you take tacrolimus or cyclosporine after a transplant, expect more frequent blood level checks once amlodipine starts.
- Grapefruit juice and aluminum or magnesium antacids did not change amlodipine levels, so they need no special spacing.
Patient information guide A plain-language walkthrough of Amlodipine, written from its FDA label.
What Amlodipine is used for
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Amlodipine is used for several heart and blood vessel conditions.
- High blood pressure (hypertension), to lower blood pressure and reduce the risk of strokes and heart attacks
- Chronic stable angina (predictable chest pain)
- Vasospastic angina (Prinzmetal's or variant angina)
- Angiographically documented coronary artery disease in patients without heart failure or an ejection fraction below 40%
- Sdamlo oral solution: high blood pressure in adults and children 6 years and older; the coronary artery disease uses are listed for adults
How Amlodipine works
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Amlodipine is a calcium channel blocker. It stops calcium from moving into blood vessel and heart muscle cells. Because it acts more on blood vessels, it relaxes and widens the arteries. This lowers blood pressure and reduces the heart's workload and oxygen needs. In vasospastic angina, it helps block spasm in the heart's arteries.
Amlodipine dosage
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Amlodipine is taken by mouth, usually once a day. Your prescriber adjusts the dose to your blood pressure goals, usually waiting 1 to 2 weeks between steps.
- Smaller, frail, or older adults and people with liver problems may start lower
- Katerzia suspension should be shaken before use
- Follow your prescriber and product label
Dosing details from the FDA-approved label
From the Amlodipine prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.
- Adults - hypertension (usual initial dose)
- 5 mg once daily
- Adjust according to blood pressure goals, in general waiting 7 to 14 days between titration steps, titrating more rapidly if clinically warranted provided the patient is assessed frequently
- Maximum: 10 mg once daily
- Small, fragile, or elderly patients, or patients with hepatic insufficiency (hypertension)
- May be started on 2.5 mg once daily
- This dose may be used when adding amlodipine to other antihypertensive therapy
- small, fragile, elderly or hepatic insufficiency
- Chronic stable or vasospastic angina
- 5 to 10 mg once daily
- Most patients will require 10 mg for adequate effect
- lower dose suggested in the elderly and in patients with hepatic insufficiency
- Coronary artery disease
- 5 to 10 mg once daily
- In clinical studies, the majority of patients required 10 mg
- Pediatric patients ages 6 to 17 years - hypertension
- 2.5 mg to 5 mg once daily
- Maximum: Doses in excess of 5 mg daily have not been studied in pediatric patients
Read the label’s full dosing text
2 DOSAGE AND ADMINISTRATION • Adult recommended starting dose: 5 mg once daily with maximum dose 10 mg once daily. ( 2.1 ) o Small, fragile, or elderly patients, or patients with hepatic insufficiency may be started on 2.5 mg once daily. ( 2.1 ) • Pediatric starting dose: 2.5 mg to 5 mg once daily. ( 2.2 ) Important Limitation: Doses in excess of 5 mg daily have not been studied in pediatric patients. Error! Hyperlink reference not valid. 2.1 Adults The usual initial antihypertensive oral dose of amlodipine besylate tablets is 5 mg once daily, and the maximum dose is 10 mg once daily. Small, fragile, or elderly patients, or patients with hepatic insufficiency may be started on 2.5 mg once daily and this dose may be used when adding amlodipine besylate tablets to other antihypertensive therapy. Adjust dosage according to blood pressure goals. In general, wait 7 to 14 days between titration steps. Titrate more rapidly, however, if clinically warranted, provided the patient is assessed frequently. Angina: The recommended dose for chronic stable or vasospastic angina is 5 to 10 mg, with the lower dose suggested in the elderly and in patients with hepatic insufficiency. Most patients will require 10 mg for adequate effect . Coronary artery disease: The recommended dose range for patients with coronary artery disease is 5 to 10 mg once daily. In clinical studies, the majority of patients required 10 mg [ see Clinical Studies (14.4) ]. 2.2 Children The effective antihypertensive oral dose in pediatric patients ages 6 to 17 years is 2.5 mg to 5 mg once daily. Doses in excess of 5 mg daily have not been studied in pediatric patients [see Clinical Pharmacology (12.4) , Clinical Studies (14.1) ].
2.1 Adults The usual initial antihypertensive oral dose of amlodipine besylate tablets is 5 mg once daily, and the maximum dose is 10 mg once daily. Small, fragile, or elderly patients, or patients with hepatic insufficiency may be started on 2.5 mg once daily and this dose may be used when adding amlodipine besylate tablets to other antihypertensive therapy. Adjust dosage according to blood pressure goals. In general, wait 7 to 14 days between titration steps. Titrate more rapidly, however, if clinically warranted, provided the patient is assessed frequently.
Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →
Amlodipine side effects
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Amlodipine is generally well tolerated. Common side effects include:
Common side effects
- Swelling (edema), especially of the ankles and feet, which is more likely at higher doses
- Tiredness (fatigue)
- Dizziness
- Flushing (feeling warm or red in the face)
- Palpitations (feeling your heartbeat)
- Nausea
- Stomach pain
- Sleepiness (somnolence)
When to get medical help
- Call your doctor if your chest pain gets worse or you have a heart attack after starting amlodipine or raising the dose
- Get help if you feel faint or very dizzy from low blood pressure
- Report yellowing of the skin or eyes (jaundice), which may signal liver problems
- Seek urgent care for signs of a serious allergic reaction, such as swelling of the face or throat (angioedema)
- Tell your doctor about severe or worsening swelling
- In a suspected overdose, get emergency help right away
Amlodipine warnings and precautions
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- Worsening angina or heart attack can occur after starting or increasing the dose, especially with severe obstructive coronary artery disease
- Symptomatic low blood pressure is possible, especially with severe aortic stenosis
- Severe liver problems require slow dose increases
- Liver enzyme elevations and jaundice have been reported after the drug reached the market
Amlodipine interactions
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Some medicines change how amlodipine or other drugs work.
- Simvastatin: levels rise, so the dose should be limited
- Cyclosporine and tacrolimus: levels may rise, so monitoring is needed
- CYP3A inhibitors such as diltiazem, itraconazole, and clarithromycin: increase amlodipine exposure
- Sildenafil: both lower blood pressure
- Grapefruit juice: did not change amlodipine exposure
Interactions listed in the FDA-approved label
From the Amlodipine prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.
- CYP3A inhibitors (moderate and strong): Co-administration results in increased systemic exposure to amlodipine. May require dose reduction; monitor for symptoms of hypotension and edema to determine the need for dose adjustment.
- CYP3A inducers: No information is available on the quantitative effects of CYP3A inducers on amlodipine. Closely monitor blood pressure when co-administered.
- Sildenafil: When used in combination, each agent independently exerted its own blood pressure lowering effect. Monitor for hypotension when co-administered with amlodipine.
- Simvastatin: Co-administration with amlodipine increases the systemic exposure of simvastatin (77% increase with 10 mg amlodipine and 80 mg simvastatin). Limit the dose of simvastatin in patients on amlodipine to 20 mg daily.
- Cyclosporine: Amlodipine may increase systemic exposure of cyclosporine; an average 40% increase in trough levels was seen in renal transplant patients (N=11). Frequent monitoring of trough blood levels is recommended and adjust the dose when appropriate.
- Tacrolimus: Amlodipine may increase systemic exposure of tacrolimus; a 2.5- to 4-fold increase was seen in CYP3A5 expressers. Frequent monitoring of trough blood levels is recommended and adjust the dose when appropriate.
- Cimetidine, magnesium- and aluminum hydroxide antacids, grapefruit juice: Have no impact on the exposure to amlodipine.
- Diltiazem: 180 mg daily diltiazem with 5 mg amlodipine in elderly hypertensive patients resulted in a 60% increase in amlodipine systemic exposure.
- Erythromycin: Did not significantly change amlodipine systemic exposure in healthy volunteers.
- Digoxin, phenytoin, warfarin, indomethacin, atorvastatin, ethanol: In vitro, amlodipine has no effect on plasma protein binding of digoxin, phenytoin, warfarin and indomethacin; amlodipine does not affect exposure to atorvastatin, digoxin, ethanol and the warfarin prothrombin response time.
Read the label’s full interactions text
7 DRUG INTERACTIONS • Do not exceed doses greater than 20 mg daily of simvastatin. ( 7.2 ) 7.1 Impact of Other Drugs on Amlodipine CYP3A Inhibitors Co-administration with CYP3A inhibitors (moderate and strong) results in increased systemic exposure to amlodipine and may require dose reduction. Monitor for symptoms of hypotension and edema when amlodipine is co-administered with CYP3A inhibitors to determine the need for dose adjustment [see Clinical Pharmacology (12.3) ] . CYP3A Inducers No information is available on the quantitative effects of CYP3A inducers on amlodipine. Blood pressure should be closely monitored when amlodipine is co-administered with CYP3A inducers. Sildenafil Monitor for hypotension when sildenafil is co-administered with amlodipine [see Clinical Pharmacology (12.2) ] . 7.2 Impact of Amlodipine on Other Drugs Simvastatin Co-administration of simvastatin with amlodipine increases the systemic exposure of simvastatin. Limit the dose of simvastatin in patients on amlodipine to 20 mg daily [see Clinical Pharmacology (12.3) ] . Immunosuppressants Amlodipine may increase the systemic exposure of cyclosporine or tacrolimus when co-administered. Frequent monitoring of trough blood levels of cyclosporine and tacrolimus is recommended and adjust the dose when appropriate [see Clinical Pharmacology (12.3) ] .
Drug interactions Sildenafil: When amlodipine and sildenafil were used in combination, each agent independently exerted its own blood pressure lowering effect [see Drug Interactions (7.1) ] .
Drug interactions In vitro data indicate that amlodipine has no effect on the human plasma protein binding of digoxin, phenytoin, warfarin, and indomethacin. 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.
Excerpted — the section continues on the label. Read the full Drug Interactions section on DailyMed →
Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.
Before taking Amlodipine
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- Do not use if you are allergic to amlodipine
- Tell your doctor about liver problems
- Older adults usually start at a lower dose
- Not established for children under 6
- Discuss pregnancy and breastfeeding with your doctor
- Kidney problems do not usually require a lower starting dose
Amlodipine overdose
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Too much amlodipine can cause marked low blood pressure and possibly a fast heartbeat. A large overdose needs emergency care with heart and breathing monitoring and blood pressure support. Dialysis is unlikely to help.
What Amlodipine does in the body
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Amlodipine widens blood vessels, lowering blood pressure while standing and lying down. Heart rate does not change significantly with long-term use. Its blood pressure effect lasts at least 24 hours with once-daily dosing. It does not change heart conduction.
How your body processes Amlodipine
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Amlodipine is absorbed slowly, with peak levels at 6 to 12 hours. It is mostly broken down by the liver into inactive products, then cleared in the urine. Its half-life is about 30 to 50 hours, and steady levels are reached after 7 to 8 days. Older adults and people with liver problems clear it more slowly.
How to store Amlodipine
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Store bottles at controlled room temperature, 59° to 86°F (15° to 30°C) and dispense in tight, light-resistant containers (USP). store amlodipine besylate tablets? Keep amlodipine besylate tablets away from children.
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Supplements & herbs that interact with Amlodipine
232 supplements and herbal products have documented interactions with Amlodipine in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 7
- Moderate · 183
- Minor · 42
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
Nutrient depletion considerations
Amlodipine has been associated with lower levels of 2 nutrients in the clinical literature. This does not mean a deficiency will occur — it means these may be worth discussing with your pharmacist or healthcare provider, especially with long-term use.
Educational information from a licensed clinical database (Natural Medicines) — not medical advice. Do not start or stop medications or supplements without professional guidance.
Amlodipine: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Amlodipine — the kind of thing our pharmacy team would talk through with you at the counter.
What is amlodipine for?
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How do I take it?
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What side effects should I expect?
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When should I call my doctor right away?
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Can I take it with other medicines?
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Is it safe in pregnancy or breastfeeding?
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Is Amlodipine available over the counter?
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When was Amlodipine first available?
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Who makes Amlodipine?
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Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More about Amlodipine on HelloPharmacist
Amlodipine forms and strengths (how it comes)
Amlodipine is available in 3 forms. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Tablet
How this form is used
- Amlodipine besylate tablets are used for high blood pressure, chronic stable angina, vasospastic angina, and coronary artery disease
- Norvasc is used for high blood pressure and angina
- Norvasc is taken by mouth once daily
- Amlodipine besylate tablets are taken by mouth once daily
Oral solution
How this form is used
- Sdamlo is used to treat high blood pressure in adults and children 6 years and older
- Sdamlo is also used for angina and coronary artery disease in adults
- Norliqva is taken by mouth once daily
- Sdamlo is taken by mouth once daily
- Follow your prescriber's directions for your dose
Oral suspension
How this form is used
- Katerzia is used for high blood pressure, angina, and coronary artery disease
- Katerzia should be shaken before using
- Katerzia is taken by mouth once daily
Amlodipine on the U.S. market: products, makers and brands
How Amlodipine appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
44 companies list 196 Amlodipine product records with the FDA, mostly as tablet, oral solution, oral suspension; the earliest marketing or approval year on record is 1992. Brand names on the directory include Katerzia, Norvasc, Amvaz and 3 more; the rest are generics.
FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
Also listed with the FDA, not a patient dose form: Powder (28) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
How widely Amlodipine is used (Medicaid data)
A general measure of how commonly Amlodipine is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Amlodipine is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Amlodipine prescribed? Of the 1,601 medications we measure, Amlodipine ranks #16 by Medicaid prescriptions — more than 99% of them.
Utilization by Amlodipine product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
amlodipine 10 MG Oral Tablet Most dispensed
Summed across the 28 of 340 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 308135
amlodipine 5 MG Oral Tablet
Summed across the 32 of 289 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 197361
amlodipine 2.5 MG Oral Tablet
Summed across the 21 of 190 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 308136
amlodipine 1 MG/ML Oral Suspension
Summed across the 1 of 1 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2184120
amlodipine 1 MG/ML Oral Solution
Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2599173
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Amlodipine, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 83 of 822 listed Amlodipine NDCs with Medicaid activity.
Compare Amlodipine products
A representative set of FDA-listed product records for Amlodipine — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Oral solution | ||||
| 1 mg/mL | Oral | CMP Pharma, Inc. × 2 listings | NDA | View NDC → |
| 5 mg/5 mg | Oral | Pangea Pharmaceuticals, LLC | NDA | View NDC → |
| 💊Oral suspension | ||||
| 1 mg/mL | Oral | Azurity Pharmaceuticals, Inc. | NDA | View NDC → |
| 💊Tablet | ||||
| 2.5 mg | Oral | A-S Medication Solutions × 4 listings | ANDA | View NDC → |
| 5 mg | Oral | A-S Medication Solutions × 4 listings | ANDA | View NDC → |
| 10 mg | Oral | A-S Medication Solutions × 6 listings | ANDA | View NDC → |
| 5 mg | Oral | American Health Packaging × 2 listings | ANDA | View NDC → |
| 10 mg | Oral | American Health Packaging × 2 listings | ANDA | View NDC → |
| 2.5 mg | Oral | Aphena Pharma Solutions - Tennessee, LLC × 2 listings | ANDA | View NDC → |
| 5 mg | Oral | Aphena Pharma Solutions - Tennessee, LLC × 7 listings | ANDA | View NDC → |
| 10 mg | Oral | Aphena Pharma Solutions - Tennessee, LLC × 7 listings | ANDA | View NDC → |
| 10 mg | Oral | Aphena Pharma Solutions - Tennessee, LLC | NDA AUTHORIZED GENERIC | View NDC → |
| 2.5 mg | Oral | Ascend Laboratories, LLC × 2 listings | ANDA | View NDC → |
| 5 mg | Oral | Ascend Laboratories, LLC × 2 listings | ANDA | View NDC → |
| 10 mg | Oral | Ascend Laboratories, LLC × 2 listings | ANDA | View NDC → |
| 2.5 mg | Oral | Aurobindo Pharma Limited | ANDA | View NDC → |
| 5 mg | Oral | Aurobindo Pharma Limited | ANDA | View NDC → |
| 10 mg | Oral | Aurobindo Pharma Limited | ANDA | View NDC → |
| 2.5 mg | Oral | AvKARE | ANDA | View NDC → |
| 5 mg | Oral | AvKARE | ANDA | View NDC → |
| 10 mg | Oral | AvKARE | ANDA | View NDC → |
| 10 mg | Oral | Boswell Pharmacy Services LLC d/b/a BPS Wholesale | ANDA | View NDC → |
| 2.5 mg | Oral | Bryant Ranch Prepack × 4 listings | ANDA | View NDC → |
| 5 mg | Oral | Bryant Ranch Prepack × 4 listings | ANDA | View NDC → |
| 10 mg | Oral | Bryant Ranch Prepack × 5 listings | ANDA | View NDC → |
| 2.5 mg | Oral | Cardinal Health 107, LLC | ANDA | View NDC → |
| 5 mg | Oral | Cardinal Health 107, LLC | ANDA | View NDC → |
| 10 mg | Oral | Cardinal Health 107, LLC | ANDA | View NDC → |
| 2.5 mg | Oral | China Resources Saike Pharmaceutical Co., Ltd. | ANDA | View NDC → |
| 5 mg | Oral | China Resources Saike Pharmaceutical Co., Ltd. | ANDA | View NDC → |
| 10 mg | Oral | China Resources Saike Pharmaceutical Co., Ltd. | ANDA | View NDC → |
| 2.5 mg | Oral | Cipla USA Inc. × 2 listings | ANDA | View NDC → |
| 5 mg | Oral | Cipla USA Inc. × 2 listings | ANDA | View NDC → |
| 10 mg | Oral | Cipla USA Inc. × 2 listings | ANDA | View NDC → |
| 2.5 mg | Oral | Coupler LLC | ANDA | View NDC → |
| 10 mg | Oral | Coupler LLC | ANDA | View NDC → |
| 2.5 mg | Oral | Direct Rx | ANDA | View NDC → |
| 2.5 mg | Oral | Direct_Rx | ANDA | View NDC → |
| 5 mg | Oral | Direct_Rx | ANDA | View NDC → |
| 10 mg | Oral | Direct_Rx | ANDA | View NDC → |
| 2.5 mg | Oral | Epic Pharma, LLC | ANDA | View NDC → |
| 5 mg | Oral | Epic Pharma, LLC | ANDA | View NDC → |
| 10 mg | Oral | Epic Pharma, LLC | ANDA | View NDC → |
| 2.5 mg | Oral | Exelan Pharmaceuticals, Inc. × 2 listings | ANDA | View NDC → |
| 5 mg | Oral | Exelan Pharmaceuticals, Inc. × 2 listings | ANDA | View NDC → |
| 10 mg | Oral | Exelan Pharmaceuticals, Inc. × 2 listings | ANDA | View NDC → |
| 5 mg | Oral | GSMS, Incorporated | ANDA | View NDC → |
| 10 mg | Oral | GSMS, Incorporated | ANDA | View NDC → |
| 5 mg | Oral | Lake Erie Medical DBA Quality Care Products LLC | ANDA | View NDC → |
| 5 mg | Oral | Legacy Pharmaceutical Packaging, LLC | ANDA | View NDC → |
| 10 mg | Oral | Legacy Pharmaceutical Packaging, LLC × 2 listings | ANDA | View NDC → |
| 2.5 mg | Oral | Lupin Pharmaceuticals, Inc. | ANDA | View NDC → |
| 5 mg | Oral | Lupin Pharmaceuticals, Inc. | ANDA | View NDC → |
| 10 mg | Oral | Lupin Pharmaceuticals, Inc. | ANDA | View NDC → |
| 2.5 mg | Oral | Major Pharmaceuticals | ANDA | View NDC → |
| 5 mg | Oral | Major Pharmaceuticals | ANDA | View NDC → |
| 10 mg | Oral | Major Pharmaceuticals | ANDA | View NDC → |
| 2.5 mg | Oral | Mylan Pharmaceuticals Inc. | NDA AUTHORIZED GENERIC | View NDC → |
| 5 mg | Oral | Mylan Pharmaceuticals Inc. | NDA AUTHORIZED GENERIC | View NDC → |
| 10 mg | Oral | Mylan Pharmaceuticals Inc. | NDA AUTHORIZED GENERIC | View NDC → |
| 2.5 mg | Oral | NCS HealthCare of KY, LLC dba Vangard Labs | ANDA | View NDC → |
| 5 mg | Oral | NCS HealthCare of KY, LLC dba Vangard Labs | ANDA | View NDC → |
| 10 mg | Oral | NCS HealthCare of KY, LLC dba Vangard Labs | ANDA | View NDC → |
Showing 110 of 196 products — FDA National Drug Code Directory. See every product, package size and price: browse all 196 Amlodipine NDCs →
Amlodipine side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Amlodipine — a signal of what to watch for, not proof the drug caused it.
The effects most often named in FDA reports that mention Amlodipine are fatigue, diarrhoea, nausea; about 74% of the reports were classed as serious. These are voluntary reports, so they show what people report, not how often it happens.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Amlodipine in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
Amlodipine FDA approval history
How Amlodipine went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Amlodipine was first approved by the FDA in 1992 (Brand: NORVASC · Viatris); the first generic version was approved in 2005. It remains available in U.S. pharmacies today.
Source: Drugs@FDA.
Amlodipine recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
The FDA’s enforcement reports list one Amlodipine recall since July 2021. It is no longer listed as ongoing. A recall names specific lots from one company, so check the lot number on your own bottle rather than assuming every product is affected; your pharmacist can check whether your supply came from an affected lot.
- Amlodipine Besylate Tablets, USP 10 mg, 1000-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 U.S, Manufactured by: Lupin Limited, Aurangabad 431 210 In… Lots: Lot #: A102887, Exp. 6/2023 FDA record D-0899-2023 →
Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 17767 6 dose forms · 12 strengths
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Dose form (SCDF) Chewable Tablet RxCUI 2748468No current FDA listingClinical drug / strength (SCD) 1.25 MGRxCUI 2748469 -
Dose form (SCDF) Disintegrating Oral Tablet RxCUI 757673In current FDA listingsClinical drug / strength (SCD) 2.5 MGRxCUI 7576755 MGRxCUI 75767610 MGRxCUI 757674 -
Dose form (SCDF) Oral Solution RxCUI 2599172In current FDA listingsClinical drug / strength (SCD) 1 MG/MLRxCUI 2599173 -
Dose form (SCDF) Oral Suspension RxCUI 2184119In current FDA listingsClinical drug / strength (SCD) 1 MG/MLRxCUI 2184120 -
Dose form (SCDF) Oral Tablet RxCUI 370573In current FDA listings -
Dose form (SCDF) Powder for Oral Solution RxCUI 2726057In current FDA listings
Look up RxCUI 17767 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
Amlodipine supply and shortage status
Whether Amlodipine is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
💵 What Amlodipine costs pharmacies (NADAC benchmark)
The national average invoice price pharmacies pay for the drug itself, from CMS's NADAC survey (data as of Sep 30, 2026). This is a supply-cost benchmark — not a retail price and not what you'd pay at the counter.
| Form | Strength | Pharmacy acquisition benchmark | |
|---|---|---|---|
| Tablet · Oral | 10 mg | $11.19–$11.94 per tablet | NDC details & price history |
| Tablet · Oral | 5 mg | $8.14–$8.69 per tablet | NDC details & price history |
| Tablet · Oral | 2.5 mg | $8.70 per tablet | NDC details & price history |
| Solution · Oral | 1 mg/mL | $3.22 per mL | NDC details & price history |
| Suspension · Oral | 1 mg/mL | $4.20 per mL | NDC details & price history |
Source: CMS National Average Drug Acquisition Cost (NADAC), a survey of retail pharmacy invoice prices. Benchmarks shown are the range across package sizes of a representative product for each form and strength — other manufacturers' products may differ.
Amlodipine brand names
Amlodipine is sold under 6 brand names in the FDA directory — Katerzia, Norvasc, Amvaz, Norliqva and others. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Amlodipine: manufacturers and labelers
44 companies list Amlodipine products with the FDA. By number of product records, the largest are Aphena Pharma Solutions - Tennessee, LLC, A-S Medication Solutions, Bryant Ranch Prepack. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
…and 20 more on the FDA NDC directory.
Sources for this Amlodipine page
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How this page is built
HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Pangea Pharmaceuticals, LLC is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →