Quick answers
- What is Caduet?
- Caduet is a brand name of Amlodipine and atorvastatin, a prescription medicine. The FDA NDC Directory lists 16 Caduet products in 8 strengths and forms.
- Who makes Caduet?
- Pharmacia holds the FDA application for Caduet (NDA021540, approved January 30, 2004). 1 other company (repackagers or distributors) also list Caduet products.
- Is there a generic or store brand of Caduet?
- Yes. The FDA NDC Directory lists 47 other products with the same active ingredients, strength and form as a Caduet product, 47 of them generic. Ask your pharmacist whether one is right for you.
- Has Caduet been recalled?
- FDA enforcement reports list 2 recalls of Caduet products; the newest started February 5, 2020. A recall usually concerns specific lots, not every product.
What Caduet is
Each Caduet product as listed in the FDA NDC Directory, by active ingredient, strength and form, with its official label. “Same medicine, other names” counts the other products with exactly the same active ingredients, strength and form (generic versions, store brands and other brands); inactive ingredients can differ.
Amlodipine and atorvastatin · prescription medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| amlodipine besylate 10 mg · atorvastatin calcium trihydrate 10 mg tablet, film coated (oral) | Caduet | 7 products, 6 companies | DailyMed |
| amlodipine besylate 10 mg · atorvastatin calcium trihydrate 20 mg tablet, film coated (oral) | Caduet | 6 products, 6 companies | DailyMed |
| amlodipine besylate 10 mg · atorvastatin calcium trihydrate 40 mg tablet, film coated (oral) | Caduet | 6 products, 6 companies | DailyMed |
| amlodipine besylate 10 mg · atorvastatin calcium trihydrate 80 mg tablet, film coated (oral) | Caduet | 5 products, 5 companies | DailyMed |
| amlodipine besylate 5 mg · atorvastatin calcium trihydrate 10 mg tablet, film coated (oral) | Caduet | 6 products, 6 companies | DailyMed |
| amlodipine besylate 5 mg · atorvastatin calcium trihydrate 20 mg tablet, film coated (oral) | Caduet | 6 products, 6 companies | DailyMed |
| amlodipine besylate 5 mg · atorvastatin calcium trihydrate 40 mg tablet, film coated (oral) | Caduet | 6 products, 6 companies | DailyMed |
| amlodipine besylate 5 mg · atorvastatin calcium trihydrate 80 mg tablet, film coated (oral) | Caduet | 5 products, 5 companies | DailyMed |
Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Amlodipine and atorvastatin →
FDA approval
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Holder | First approved | Products |
|---|---|---|---|
| NDA021540 | Pharmacia | January 30, 2004 | 16 |
Companies that list Caduet
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Caduet products.
- Pfizer Laboratories Div Pfizer Inc8 products
- Viatris Specialty LLC8 products
Recalls
From FDA enforcement reports, matched by the product’s NDC code or label. A recall usually covers specific lots: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
February 5, 2020 · Class II · Terminated · D-0841-2020
Defective Container: products potentially could have been packaged in defective bottles, with a notched rim, that could cause inadequate foil sealing resulting in lack of moisture protection.
Caduet (amlodipine besylate/atorvastatin calcium) Tablets, 10 mg/20 mg*, 30-count bottle, Rx only, Distributed by: Pfizer Labs, Division of Pfizer Inc. NY, NY 10017, Made in Germany, NDC 0069-2180-30. — Pfizer Inc.
-
February 5, 2020 · Class II · Terminated · D-0842-2020
Defective Container: products potentially could have been packaged in defective bottles, with a notched rim, that could cause inadequate foil sealing resulting in lack of moisture protection.
Caduet (amlodipine besylate/atorvastatin calcium) Tablets, 10 mg/10 mg*, 30-count bottle, Rx only, Distributed by: Pfizer Labs, Division of Pfizer Inc. NY, NY 10017, Made in Germany, NDC 0069-2160-30. — Pfizer Inc.
Sources
- 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 labeling (SPL, 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
- NADAC (National Average Drug Acquisition Cost) 2026 — Centers for Medicare & Medicaid Services (CMS), data.medicaid.gov, list of November 4, 2026, retrieved November 7, 2026
Which names get a brand page: a name the NDC Directory lists for a medicine, held by one company (the FDA application holder, or the company named on most of its products), that is not just a description, and that is not the only product of its medicine.