Quick answers
- What is Amlodipine used for?
- The FDA-approved label (Norvasc, Viatris Specialty LLC, February 15, 2023) says: “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 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. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Amlodipine have a boxed warning?
- No. None of the 123 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Amlodipine?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Amlodipine been recalled?
- FDA enforcement reports list 6 recalls of products of this medicine; the newest started June 27, 2023 (Class III). A recall usually concerns specific lots, not every product.
- Who makes Amlodipine?
- 44 companies list prescription products of Amlodipine in the FDA NDC Directory, including Aphena Pharma Solutions - Tennessee, LLC, A-S Medication Solutions and Bryant Ranch Prepack.
What Amlodipine is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
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 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. …
— FDA label: Norvasc, Viatris Specialty LLC, effective February 15, 2023. Read the full label on DailyMed →
The FDA has 123 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 123 FDA labels for this medicine have a boxed warning.
Forms and how it is given
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 |
|---|---|---|
| amlodipine 1 mg/mL solution | Brand: Norliqva | $3.21 per mL |
| amlodipine besylate 10 mg tablet | Generic | $0.0144 per tablet |
| amlodipine besylate 10 mg tablet | Brand: Norvasc | $11.92 per tablet |
| amlodipine besylate 2.5 mg tablet | Generic | $0.0111 per tablet |
| amlodipine besylate 2.5 mg tablet | Brand: Norvasc | $8.70 per tablet |
| amlodipine besylate 5 mg tablet | Generic | $0.0101 per tablet |
| amlodipine besylate 5 mg tablet | Brand: Norvasc | $8.69 per tablet |
NADAC list of November 4, 2026; these prices took effect between January 1, 2026 and October 21, 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.
- Aphena Pharma Solutions - Tennessee, LLC17 products
- A-S Medication Solutions14 products
- Bryant Ranch Prepack13 products
- Proficient Rx LP11 products
- PD-Rx Pharmaceuticals, Inc.9 products
- Preferred Pharmaceuticals Inc.8 products
- Remedyrepack Inc.8 products
- NuCare Pharmaceuticals, Inc.7 products
- Cipla USA Inc.6 products
- Exelan Pharmaceuticals Inc.6 products
- Ascend Laboratories, LLC6 products
- Northwind Health Company, LLC5 products
- NCS HealthCare of KY, LLC dba Vangard Labs5 products
- American Health Packaging4 products
- Direct_Rx4 products
- Unichem Pharmaceuticals (USA), Inc.3 products
- Epic Pharma, LLC3 products
- Quallent Pharmaceuticals Health LLC3 products
- Cardinal Health 107, LLC3 products
- Viatris Specialty LLC3 products
- Zydus Lifesciences Limited3 products
- Aurobindo Pharma Limited3 products
- Major Pharmaceuticals3 products
- Mylan Pharmaceuticals Inc.3 products
- Rising Pharma Holdings, Inc.3 products
- Lupin Pharmaceuticals, Inc.3 products
- Legacy Pharmaceutical Packaging, LLC3 products
- Teva Pharmaceuticals, Inc.3 products
- Pangea Pharmaceuticals, LLC3 products
- Safecor Health LLC3 products
- Redpharm Drug3 products
- Zydus Pharmaceuticals USA Inc.3 products
- Oxford Pharmaceuticals, LLC3 products
- Pfizer Laboratories Div Pfizer Inc3 products
- AvKARE3 products
- China Resources Saike Pharmaceutical Co., Ltd.3 products
- GSMS, Incorporated2 products
- Quality Care Products, LLC2 products
- Coupler LLC2 products
- Unit Dose Solutions, Inc.2 products
- QPharma, Inc.2 products
- CMP Pharma, Inc.2 products
- St. Mary's Medical Park Pharmacy1 product
- Boswell Pharmacy Services LLC d/b/a BPS Wholesale1 product
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 |
|---|---|---|---|
| NDA019787 NORVASC | Viatris | July 31, 1992 | 45, latest October 30, 2017 2017: Labeling · 2017: Labeling · 2015: Labeling |
| NDA214439 NORLIQVA | Cmp Dev LLC | February 24, 2022 | 1, latest February 2, 2026 2026: Labeling |
| NDA219531 SDAMLO | Brillian Pharma | July 24, 2025 | 1, latest May 8, 2026 2026: Labeling |
Generic approvals (14)
- ANDA076719Macleods Pharms · May 23, 2007
- ANDA076846Teva · June 28, 2007
- ANDA078226Zydus Pharms USA · July 9, 2007
- ANDA078043Lupin · July 12, 2007
- ANDA078021Aurobindo Pharma · July 17, 2007
- ANDA077955Invagen Pharms · August 28, 2007
- ANDA077073Cipla · September 26, 2007
- ANDA078552Epic Pharma LLC · April 8, 2009
- ANDA078925Alkem · May 4, 2009
- ANDA078414Oxford Pharms · April 7, 2010
- ANDA090752China Resources · April 15, 2011
- ANDA201380Graviti Pharms · April 13, 2012
- ANDA203245Unichem · October 21, 2013
- ANDA206367Invagen Pharms · December 10, 2015
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.
-
June 27, 2023 · Class III · Terminated · D-0899-2023
Subpotent Drug: Out-of-Specification test results observed in assay test at 21-month long term stability study.
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 India, NDC 68180-721-03 — Lupin Pharmaceuticals Inc.
-
October 3, 2018 · Class III · Terminated · D-0012-2019
Subpotent Drug: One lot of product does not meet the product specification for Assay test at 3 month long term stability condition.
Amlodipine Besylate USP 10 mg Tablets, 1000-count bottles, Rx Only, Manufactured by: Cipla Ltd., Verna Goa, India, Manufactured for: Cipla USA, Inc. 1560 Sawgrass Corporate Parkway, Suite 130, Sunrise FL 33323 UPC 369097 — InvaGen Pharmaceuticals, Inc.
-
May 5, 2017 · Class III · Terminated · D-1134-2017
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 Amlodipine Besylate 10 mg.
AMLODIPINE BESYLATE TABLET, USP, 10 mg, 1000 count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013, India, Distributed by: Ascend Laboratories, LLC Montvale, NJ 07645, NDC 67877-199-10 — Ascend Laboratories LLC
-
February 19, 2016 · Class III · Terminated · D-1493-2016
CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
Amlodipine Besylate Tablets USP, 10mg, 1000-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited Goa 403 722 INDIA, NDC 68180-752-03 — Lupin Limited
-
February 19, 2016 · Class III · Terminated · D-1492-2016
CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
Amlodipine Besylate Tablets USP, 2.5mg, 90-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited Goa 403 722 INDIA, NDC 68180-750-09 — Lupin Limited
-
October 1, 2014 · Class III · Terminated · D-0257-2015
Discoloration: Brown spots were noted embedded in Amlodipine Besylate Tablets, 10 mg, Lot # MP4344.
Amlodipine Besylate Tablets, USP 10 mg, Rx Only, 90 Tablets per bottle, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals USA Inc., Pennington, NJ 08534, NDC 68382-123-16 — Zydus Pharmaceuticals USA 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) — Norvasc, Viatris Specialty LLC, effective February 15, 2023; 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 →