Caduet Tablet, Film Coated
NDC 58151-063

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 58151-063?
  5. Caduet Uses
  6. Active Ingredients
  7. Active Ingredients UNII Codes
  8. Inactive Ingredients UNII Codes
  9. NDC to RxNorm Crosswalk
  10. Pharmacologic Classes

Product Information

Caduet (amlodipine and atorvastatin) is a NDA-approved product labeled by Viatris Specialty Llc. This product contains 2 medications: amlodipine and atorvastatin. It is supplied as a white tablet, film coated for oral administration. This product entry covers the primary NDC 58151-063 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
58151-063
Proprietary Name:
Caduet
Non-Proprietary Name: [1]
Amlodipine And Atorvastatin
Substance Name: [2]
Amlodipine Besylate; Atorvastatin Calcium Trihydrate
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:

Clinical Specifications

Dosage Form:
Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
Administration Route(s): [4]
Oral - Administration to or by way of the mouth.

Labeler & Regulatory Data

Labeler Name: [5]
Viatris Specialty Llc
Labeler Code:
58151
Product Label ID:
164394b3-d7ba-4bbf-b64b-e2dd15735ea8
FDA Application Number: [6]
NDA021540
Marketing Category: [8]
NDA - A product marketed under an approved New Drug Application.

Marketing Timeline

Start Marketing Date: [9]
02-25-2026
Listing Expiration Date: [11]
12-31-2027
Exclude Flag: [12]
N

Product Characteristics

Color(s):
WHITE (C48325)
BLUE (C48333)
Shape:
OVAL (C48345)
Size(s):
9 MM
11 MM
14 MM
17 MM
Imprint(s):
CDT;051
CDT;052
CDT;054
CDT;058
CDT;101
CDT;102
CDT;104
CDT;108
Score:
1

Code Structure Chart

Product Details

What is NDC 58151-063?

The NDC code 58151-063 is assigned by the FDA to the product Caduet. It is commonly known by its generic name, amlodipine and atorvastatin. This pharmaceutical product is labeled by Viatris Specialty Llc and is currently categorized as listed product. The medication is a tablet, film coated administered via oral route. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 58151-063-93. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.

What are the uses of this product?

This product contains 2 medications: amlodipine and atorvastatin. Amlodipine is a calcium channel blocker and is used to treat high blood pressure or prevent chest pain (angina). It works by relaxing the blood vessels so that blood can flow more easily and the heart does not need to work so hard. Lowering high blood pressure helps prevent strokes, heart attacks, and kidney problems. Preventing chest pain can help improve your ability to exercise. Atorvastatin is used along with a proper diet to help lower "bad" cholesterol and fats (such as LDL, triglycerides) and raise "good" cholesterol (HDL) in the blood. It belongs to a group of drugs known as "statins." It works by reducing the amount of cholesterol made by the liver. Lowering "bad" cholesterol and triglycerides and raising "good" cholesterol decreases the risk of heart disease and helps prevent strokes and heart attacks. In addition to eating a proper diet (such as a low-cholesterol/low-fat diet), other lifestyle changes that may help this medication work better include exercising, losing weight if overweight, and stopping smoking. Consult your doctor for more details.

What are Active Ingredients of this product?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
  • AMLODIPINE BESYLATE 10 mg/1 - A long-acting dihydropyridine calcium channel blocker. It is effective in the treatment of ANGINA PECTORIS and HYPERTENSION.
  • ATORVASTATIN CALCIUM TRIHYDRATE 80 mg/1 - A pyrrole and heptanoic acid derivative, HYDROXYMETHYLGLUTARYL-COA REDUCTASE INHIBITOR (statin), and ANTICHOLESTEREMIC AGENT that is used to reduce serum levels of LDL-CHOLESTEROL; APOLIPOPROTEIN B; and TRIGLYCERIDES. It is used to increase serum levels of HDL-CHOLESTEROL in the treatment of HYPERLIPIDEMIAS, and for the prevention of CARDIOVASCULAR DISEASES in patients with multiple risk factors.

Which are the associated UNII Codes?

The UNII codes for the active ingredients in this product are:

Which are the Inactive Ingredients associated UNII Codes?

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

What is the NDC to RxNorm Crosswalk for this product?

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
  • RxCUI: 404011 - amLODIPine besylate 5 MG / atorvastatin calcium 80 MG Oral Tablet
  • RxCUI: 404011 - amlodipine 5 MG / atorvastatin 80 MG Oral Tablet
  • RxCUI: 404011 - amlodipine (as amlodipine besylate) 5 MG / atorvastatin (as atorvastatin calcium) 80 MG Oral Tablet
  • RxCUI: 404013 - amLODIPine besylate 10 MG / atorvastatin calcium 80 MG Oral Tablet
  • RxCUI: 404013 - amlodipine 10 MG / atorvastatin 80 MG Oral Tablet

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Product & Regulatory Definitions
What is the Non-Proprietary Name? The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
What is the Substance Name? An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
What kind of product is this? Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
What are the Administration Routes? The translation of the route code submitted by the firm, indicating route of administration.
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
What is the FDA Application Number? This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
What is the Marketing Category? Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
What is the Listing Expiration Date? This is the date when the listing record will expire if not updated or certified by the product labeler.
What is the NDC Exclude Flag? This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".